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Approximately 10 years have passed since the Peritoneal Dialysis Guidelines were formulated in 2009. Much evidence has been reported during the succeeding years, which were not taken into consideration in the previous guidelines, e.g., the next peritoneal dialysis PD trial of encapsulating peritoneal sclerosis (EPS) in Japan, the significance of angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs), the effects of icodextrin solution, new developments in peritoneal pathology, and a new international recommendation on a proposal for exit-site management. It is essential to incorporate these new developments into the new clinical practice guidelines. Meanwhile, the process of creating such guidelines has changed dramatically worldwide and differs from the process of creating what were “clinical practice guides.” For this revision, we not only conducted systematic reviews using global standard methods but also decided to adopt a two-part structure to create a reference tool, which could be used widely by the society’s members attending a variety of patients. Through a working group consensus, it was decided that Part 1 would present conventional descriptions and Part 2 would pose clinical questions (CQs) in a systematic review format. Thus, Part 1 vastly covers PD that would satisfy the requirements of the members of the Japanese Society for Dialysis Therapy (JSDT). This article is the duplicated publication from the Japanese version of the guidelines and has been reproduced with permission from the JSDT.

Peritoneal equilibration test (PET) is the gold standard for evaluating peritoneal transport, and measurement of the drain volume after 4-h dwell time with glucose 4.25% is a simple means of evaluating failure of ultrafiltration. The study objective was to verify if the measurement of the volume drained after 4 h dwell of icodextrin at 7.5% (ICO), has a better correlation with the parameters of PET. Patients in a peritoneal dialysis program (N = 35) underwent three procedures: PET; determination of the drain volume after a 4-h dwell with glucose 4.25%; and determination of the drain volume after a 4-h dwell with ICO. Among patients who were classified as high transporters, the ultrafiltration volume was greater after ICO use. The ICO ultrafiltration volume correlated negatively with the ratio between the 4- and 0-h dialysate glucose concentrations (D4/D0 ratio, r = -0.579; P = 0.002), correlating positively with the dialysate-to-plasma ratio for creatinine (D/PCr ratio, r = 0.474; P = 0.002). For ICO, the area under the receiver operating characteristic curve was 0.867 and 0.792 for the D/PCr and D4/D0 ratios (P

Objective: To evaluate the effectiveness of different adhesion barriers in the prevention of de-novo adhesion development after laparoscopic myomectomy. Method: A systematic review was performed by searching seven electronic databases for all randomized clinical trials (RCT) comparing the use of any absorbable adhesion barrier (i.e. intervention group) with either no treatment or placebo (i.e. control group) in the prevention of adhesion development after laparoscopic myomectomy. Results: Eight RCT with a total of 748 participants (392 in the intervention group and 356 in the control group) were included. The assessed adhesion barrier methods were: the oxidized regenerated cellulose (ORC) in 2 studies, the auto-crosslinked hyaluronic acid (HA) gel in 2 studies, the 4% icodextrin solution in one study, the modified HA and carboxy-methylcellulose in one study, the polyethylene glycol ester trilysine amine solution plus a borate buffer solution in one study, and the polyethylene glycol amine plus dextran aldehyde polymers in another study. Conclusions: Adhesion barriers methods showing the most promising results were: ORC, auto-crosslinked HA gel and polyethylene glycol amine plus dextran aldehyde polymers.

Background and objective: During peritoneal dialysis (PD), the period of effective net peritoneal ultrafiltration during long dwells can be extended by using the colloidal osmotic agent icodextrin but there are few detailed studies on ultrafiltration with icodextrin solution exceeding 12 hours. We analysed kinetics of peritoneal ultrafiltration in relation to icodextrin and its metabolites for 16-hours dwells with icodextrin. Design, setting, participants, & measurements: In 20 clinically stable patients (mean age 54 years; 8 women; mean preceding time on PD 26 months), intraperitoneal dialysate volume (VD) was estimated from dilution of 125I-human serum albumin during 16-h dwell studies with icodextrin 7.5% solution. Osmolality and sodium were measured in dialysate and plasma. In 11 patients, fractional absorption of icodextrin from dialysate, dialysate and plasma amylase, and high and low (Mw

Emergency cesarean sections are associated with more postoperative complications than with elective cesarean sections. Seprafilm and Adept are commonly used adhesion reduction devices and have been applied in abdominal or pelvic surgery for a long time. This study focuses on comparing the short-term postoperative outcomes of emergency cesarean sections between two groups. We performed a retrospective study that included all patients who received emergency caesarean sections from the same surgeon at MacKay Memorial Hospital between August 2014 and November 2017, We analyzed the overall cases and conducted a subgroup analysis of cases with contaminated or dirty/infected wounds in regard to the rates of surgical-site infection (SSI), bandemia, delayed flatus passage, and length of hospital stay. The two groups were similar with respect to the rates of SSI, bandemia, and length of hospital stay. However, Seprafilm was associated with higher risk of delayed flatus passage over 48 h (OR: 2.67, 95% CI = 2.16&ndash, 7.64, p = 0.001). It also needs less time for recovery of the digestive system and less medical management postoperatively. In cases of contaminated or dirty/infected wounds, Adept user also had significantly lower rates (10.3% vs. 32%, p = 0.048, OR: 4.12, CI = 1.09&ndash, 15.61) of postcesarean metritis.

The 7.5% icodextrin solution is widely used for long-dwell in peritoneal dialysis (PD) regimens as an alternative osmotic agent to glucose. It has been defined as a biocompatible agent because of its iso-osmolarity and is generally safe and well tolerated. Icodextrin and its hydrolyzed metabolites are found in systemic circulation. In serum, icodextrin interferes with amylase determination causing a significantly decreased plasma amylase level making it unreliable for the diagnosis of acute pancreatitis. Lipase measurement provides an alternative and accurate method for diagnosing acute pancreatitis (AP) in patients using icodextrin. Icodextrin-induced acute pancreatitis is not well described. The literature appears limited to two case reports. We describe a case of a man with end-stage renal disease (ESRD) on PD who developed acute pancreatitis following icodextrin use. We also provide a novel possible mechanism for understanding how icodextrin causes AP. .

Background This study aimed to evaluate the longitudinal changes in cardiac structure and function in incident-automated peritoneal dialysis (APD) patients. Methods We conducted a 2-year prospective, randomized, open-label, parallel-group study to compare the efficacy of icodextrin solution versus glucose-based solution. Echocardiography was performed at baseline, 1 and 2 years. Echocardiographic parameters over 2 years were evaluated for each group, using the Friedman test. Generalized linear regression analysis was used to test the associations between baseline clinical variables and echocardiographic changes, and a multivariate model was used to analyze cardiac function between the two groups. Results A total of 43 APD patients were enrolled in the beginning of this study. Twenty patients in the icodextrin group (ICO) and 18 patients in the glucose group (GLU) completed the study. In left ventricular (LV) systolic function measurements, ejection fraction (EF) increased significantly in the GLU group. Measurements of LV diastolic function and septal early mitral annulus velocity (EMV) increased significantly from baseline to 24-months in the ICO group (5.43–5.51 ms). The GLU group showed a significant decrease in peak early diastolic velocity (EDV) (70.67–68.25 cm/s), but a significant increase in septal EMV (5.94–7.57 ms) from baseline to 24-months. No significant association was found between the baseline clinical variables and echocardiographic changes within 24 months in the generalized linear regression analysis. Multivariate models were used to investigate changes in the four primary endpoints, namely, myocardial performance index (MPI), left ventricular ejection fraction (LVEF), deceleration time (DT), and E/e′ ratio. These primary endpoints show no significant association with the baseline values in both the ICO and GLU groups. Conclusion The present study demonstrates that long-dwell icodextrin solution can maintain reasonable cardiac structure and function in incident-APD patients. Trial registration ISRCTN14931270 (retrospectively registered on 23/03/2018).

Background: 4% icodextrin is a fluid that can be instilled laparoscopically to prevent adhesion formation. There are few complications reported in the literature associated with its use. Case: A 38-year-old woman, gravida 2, para 0, abortus 2 underwent laparoscopic salpingectomy. 4% icodextrin was instilled in an effort to prevent adhesion formation. Postoperatively, the patient experienced urinary retention and gross vulvar edema that required foley catheter use until the 4% icodextrin solution had absorbed. Conclusion: Postoperative complications that may be associated with the use of 4% icodextrin include urinary retention and vulvar edema.

To assess the effectiveness of using sodium hyaluronate-based bioresorbable membrane (Seprafilm(®)) versus 4 % icodextrin solution (Adept(®)) versus no additive intraoperatively and to prevent postoperative small-bowel obstruction in patients undergoing colorectal cancer (CRC) surgery.The subjects of this retrospective study were 454 patients, who underwent CRC surgery between February 2007 and January 2010. Among the 454 enrolled patients, 114 patients received Seprafilm(®), 180 patients received Adept(®), and 160 patients received no additive, based on the year of their surgery.The overall incidences of small-bowel obstruction were 8.8, 4.3, and 6.9 %, for the Adept(®), Seprafilm(®), and no additive (control) groups, respectively. The cumulative incidence was significantly higher in the Adept(®) group than in the Seprafilm(®) and control groups (Adept(®) vs. Seprafilm(®), P = 0.043; Adept(®) vs. control group, P = 0.002). No significant difference was found between the Seprafilm group and the control group (P = 0.549). Adept(®) solution and Seprafilm(®) did not alter the liver and renal function, as assessed by blood chemistry.The use of Adept(®) significantly increased the incidence of small-bowel obstruction in patients undergoing CRC surgery.

Infections are major complications in peritoneal dialysis (PD) with a multifactorial etiology that comprises patient, microbial and dialytic factors. This study aimed at investigating the contribution of microbial biofilms on PD catheters to recalcitrant infections and their interplay with PD related-factors. A prospective observational study was performed on 47 patients attending Centro Hospitalar of Porto and Vila Nova de Gaia/Espinho to whom the catheter was removed due to infectious (n = 16) and non-infectious causes (n = 31). Microbial density on the catheter was assessed by culture methods and the isolated microorganisms identified by matrix-assisted laser desorption/ionization time-of-flight intact cell mass spectrometry. The effect of conventional and three biocompatible PD solutions on 16 Coagulase Negative Staphylococci (CNS) and 10 Pseudomonas aeruginosa strains planktonic growth and biofilm formation was evaluated. Cultures were positive in 87.5% of the catheters removed due infectious and 90.3% removed due to non-infectious causes. However, microbial yields were higher on the cuffs of catheters removed due to infection vs. non-infection. Staphylococci (CNS and Staphylococcus aureus) and P. aeruginosa were the predominant species: 32% and 20% in the infection and 43.3% and 22.7% in the non-infection group, respectively. In general, PD solutions had a detrimental effect on planktonic CNS and P. aeruginosa strains growth. All strains formed biofilms in the presence of PD solutions. The solutions had a more detrimental effect on P. aeruginosa than CNS strains. No major differences were observed between conventional and biocompatible solutions, although in icodextrin solution biofilm biomass was lower than in bicarbonate/lactate solution. Overall, we show that microbial biofilm is universal in PD catheters with the subclinical menace of Staphylococci and P. aeruginosa. Cuffs colonization may significantly contribute to infection. PD solutions differentially impact microbial species. This knowledge is important for the development of infection diagnosis, treatment and preventive strategies., This work received support from a Sociedade Portuguesa de Nefrologia (http://www.spnefro.pt) research grant to AR and a Fundação para a Ciência e Tecnologia (http://www.fct.pt) post doc grant (SFRH/BPD/73663/2010) to MM. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Post-surgical adhesions are common and can cause substantial co-morbidity. The aim of this review was to investigate the efficacy of 4 % icodextrin solution, a widely used adhesion prevention agent, in gynaecological surgery. Randomised-controlled trials comparing the use of 4 % icodextrin solution vs. Ringer’s-lactated saline (control) in women of any age undergoing fertility-conserving surgery either by laparoscopy or laparotomy were searched and meta-analysis performed. Compared to Ringer’s-lactated saline, there was no significant difference in the number of patients free from de novo adhesions at second-look laparoscopy (SLL) (odds ratio, 1.21 [0.76, 1.93]), the adhesion score reduction at SLL (mean difference (MD), 0.71 [−0.66, 2.08]), the percentage reduction in adhesion extent (MD, 5.47 [−4.18, 15.12]) or severity (MD, 13.49 [−23.78, 50.75]). The included studies reported the effect of 4 % icodextrin in different ways thus limiting meta-analysis. This is the first meta-analysis of icodextrin and the lack of evidence found to support the use of icodextrin suggests further research is required which should be presented in a uniform manner.

Skin autofluorescence (SAF) measurement is a simple, noninvasive method to assess tissue advanced glycation end products (AGE). In patients with end-stage renal disease and in those on hemodialysis AGE production is increased. Less is known about those treated with peritoneal dialysis (PD). In this study we tested if SAF is influenced by clinical and treatment characteristics in PD patients.This cross-sectional study included 198 PD patients (of those, 128 were on traditional glucose-based solutions and 70 patients were partially switched to icodextrin-based PD). SAF measurements were done with a specific AGE Reader device. The impact of patients' age, gender, current diabetes, duration of PD, cumulative glucose exposure, body mass index, smoking habits and use of icodextrin on SAF values were tested with multiple regression analysis.Our analysis revealed that patients' age, current diabetes and icodextrin use significantly increase patients' SAF values (p = 0.015, 0.012, 0.005, respectively). AGE exposure of PD patients with diabetes and on icodextrin solution is increased. Further investigation is required whether this finding is due to the icodextrin itself or for a still unspecified clinical characteristic of PD population treated with icodextrin.

Background. The purpose of this study was to analyse the changes of body composition and the effects of icodextrin dialysis solution over time on peritoneal dialysis (PD) in continuous ambulatory peritoneal dialysis (CAPD) patients. Methods. Among 183 incident patients, 75 patients finished a complete 36-month protocol. Clinical indices including daily glucose absorption and body composition, by bioelectrical impedance analysis (BIA), were measured in both groups (icodextrin group: 36 patients, non-icodextrin group: 39 patients) at the 1 st (baseline), 12th, 24th and 36th months. Results. There were significant increases in body weight and fat mass during the 36 months after initiation of CAPD. It was found that 78% of 3 years of weight gain occurred during the first year and 88% of weight gain at the end of the first year was fat mass gain. The icodextrin group showed a significantly lower percent of fat mass during the first 36 months (P < 0.05) and also less changes in body weight, fat mass, percent (%) fat mass, visceral fat area and waist/hip ratio at 1, 2 and 3 years than the non-icodextrin group. There were no significant changes in total body water (TBW), extra cellular fluid (ECF), oedema index and lean body mass (LBM) through comparable daily and ultrafiltration volume (UFV) between the two groups during the initial 3 years. Factors associated with the higher percent of fat mass gain over time on peritoneal dialysis were age, diabetes, gender (female) and non-icodextrin group (all, P < 0.01, generalized estimating equation). Conclusion. The application of icodextrin solution may be a better option to alleviate excessive fat gain over time for patients on PD.

Conventional peritoneal dialysis solutions are mostly bioincompatible in relationship with a low pH, a high glucose and glucose degradation products (GDP) concentrations inducing anatomical and functional peritoneal membrane alterations. Use of icodextrin solution instead of glucose hypertonic solution preserves peritoneal membrane minimizing glucose exposure and its peritoneal absorption. Physiological fluids with a neutral pH and less GDP seem to have a positive effect on residual renal function which declines more slowly when they are early prescribed, before highly damaged and sclerotic kidneys. Preliminary data show that patients and technique survivals are better when physiological solutions are used either for diabetic and non diabetic patients. However, these new solutions do not improve peritonitis rates except for bicarbonate solutions but this fact must still be confirmed by other studies. In spite of a higher cost, physiological solutions must be proposed mainly for patients with a low comorbidity index and a high life expectancy.

Icodextrin peritoneal dialysis solution reportedly benefits patients suffering from metabolic derangement due to glucose load from dialysate. However, the effects of icodextrin on insulin resistance and adipocytokine profile remain unclear. Subjects comprised 14 stable patients on peritoneal dialysis for6 months. Their mean age was 57 +/- 11 years and the mean duration of peritoneal dialysis was 49 +/- 30 months. Patients were classified into groups according to the index of insulin resistance (index of homeostasis model assessment: HOMA-IR): Group A, HOMA-IR2.0 (n = 7); and Group B, HOMA-IRor= 2.0 (n = 7). Glucose peritoneal dialysis solution was subsequently switched to icodextrin once daily during the night. Changes in HOMA-IR and adipocytokine profiles were examined after three months. The glucose absorption dose tended to decrease in both groups after icodextrin introduction, with significant reductions in Group B. No changes were seen in body mass index, fluid status, peritoneal dialysis dose, residual renal function or fasting plasma glucose levels in either group. Plasma insulin levels were unchanged in Group A, but decreased significantly in Group B. The index of insulin resistance was thus unchanged in Group A (from 1.4 +/- 0.4 to 1.5 +/- 0.8) and significantly decreased in Group B (from 5.9 +/- 2.2 to 3.2 +/- 0.6; P0.01). Regarding plasma adipocytokine profiles, no changes were found in plasma leptin, tissue necrosis factor-alpha or total plasminogen activator inhibitor-1 levels in either group. Plasma adiponectin levels were unchanged in Group A, but significantly increased in Group B. Icodextrin solution could ameliorate insulin resistance by decreasing insulin levels due to a reduction in the glucose load and an increase in plasma adiponectin levels.

A statistical survey conducted at the end of 2005 covered 3985 medical facilities across Japan, and 3940 facilities (98.87%) responded. The dialysis population in Japan at the end of 2005 was 257,765, which showed an increase of 9599 patients (3.87%) from the end of the previous year. The number of patients per million was 2017.6. The crude death rate for one year (from the end of 2004 to the end of 2005) was 9.5%. The mean age of the patients who began dialysis (in 2005) was 66.2 years, and the mean age of the entire dialysis population was 63.9 years. The primary diseases of the patients who began dialysis were diabetic renal disease (42.0%) and chronic glomerulonephritis (27.3%). The mean (+/-SD) serum ferritin concentration of all the dialysis patients was 191 (+/-329) ng/mL. The percentages of antihypertensive agents administered to the hemodialysis patients were as follows: calcium-channel blocker, 50.3%; angiotensin-converting enzyme inhibitor, 11.5%; and angiotensin II-receptor blocker, 33.9%. Of the peritoneal dialysis patients, 33.4% used automated peritoneal dialysis devices. Moreover, 7.3% of the peritoneal dialysis patients received dialysis treatment only in the daytime, and 15% received the treatment only at night. Icodextrin solution was used by 37.2% of the peritoneal dialysis patients. The average amount of dialysis solution used by the peritoneal dialysis patients was 7.43 (+/-2.52) L/day and the average amount of removal fluid was 0.81 (+/-0.60) L/day. A peritoneal equilibration test was conducted on 67% of the patients, and the mean dialysate to plasma creatinine ratio was 0.65 (+/-0.13). The annual incidence of peritonitis in the peritoneal dialysis patients was 19.7%. Of the 126 040 patients who responded to the inquiry of the therapeutic situation of peritoneal dialysis, 676 (0.7%) had a history of encapsulated peritoneal sclerosis and 66 (0.1%) were treated for encapsulated peritoneal sclerosis. The mean life expectancy of the dialysis population in 2003 was calculated according to sex and age. Results showed that the mean life expectancy of the dialysis population was approximately 40-60% of that of the general population of the same sex and age.

CAPD (continuous ambulatory peritoneal dialysis) にイコデキストリン透析液を使用することにより, 残腎機能が温存されるとの報告がなされている. 今回, われわれは移植残腎機能低下による腹膜透析への再導入にあたり, イコデキストリン透析液を使用して体液管理をすることにより, 移植残腎機能を保持し, さらにはQOLの改善を得た症例を経験したので報告する. 症例は70歳, 女性. 1999年に原疾患不明の慢性腎不全にて血液透析導入となり, 2001年に屍体腎移植術を施行した. その後, 徐々に移植腎機能低下を認め, 2004年6月からCAPD導入となった. 同年8月から, 夜間の腹膜透析を1.5%ブドウ糖透析液からイコデキストリン透析液に変更したところ, 1日尿量が平均542.9±248.6mL/日であったのに対し, ICO導入後から2005年6月までの1日尿量は平均1,033.0±340.5mLに増加し, それに伴う飲水量の増加も認めた. またイコデキストリン導入後より下腿浮腫の改善を認め, その後の体重は増加し標準体重に徐々に近づいてきている. 体液量に関しては, hANP (human atrial natriuretic peptide) が平均110.2±28.7pg/mLから平均36.2±6.9pg/mL, 心胸郭比が50.8%から44.7%と各々減少し, 体液量貯留が是正されていた. 移植残腎機能に関しては, イコデキストリン透析液導入後の平均s-Cr値, eGFR値 (estimated glomerular filtration rate) は安定しており, 悪化傾向を認めていない. 加えて, イコデキストリン導入後は総コレステロール値と中性脂肪値の低下を認めており, 脂質代謝は改善されていた. QOLに関しては, SF-36 (short form 36) を用いた結果によると, イコデキストリン導入前後で明らかな改善を認めている.

Summary: Background: The aim of the study was to assess plasma homocysteine concentration in peritoneal dialysis patients, and to compare the effect of different peritoneal solutions (glucose-based and icodextrin-based) on peritoneal clearance of homocysteine. Methods: The study group comprised 10 chronic peritoneal dialysis patients; the control group comprised 15 healthy, age-matched non-obese subjects with normal renal function. Patients with vitamin B12 or folate deficiency were excluded. In all subjects, plasma homocysteine and dialysis adequacy parameters were assessed at baseline. The clearance study was carried out with 2.27% glucose and 7.5% icodextrin solutions (12-h dwell time). Results: Mean dialysate concentration of homocysteine was similar for both glucose and icodextrin solutions (8.3 ± 3.2 and 8.4 ± 1.9 µmol/L, respectively), but homocysteine clearance was significantly higher for icodextrin than glucose solution (1.82 ± 0.57 vs 1.39 ± 0.53 mL/min per 1.73 m2P = 0.01). Net ultrafiltration after icodextrin solution was also higher than after glucose solution (599 ± 136 mL vs 134 ± 337 mL, P

ObjectivesTo establish intraperitoneal pressure (IPP) in a relatively large pediatric study group and to study the effects of a 3.86% glucose solution and a 7.5% icodextrin solution on IPP during a 4-hour dwell.DesignIPP was measured with the patient in a supine position. The intraperitoneal volume (IPV) was 1200 mL/m2with a 1.36% glucose solution. The influence of dialysis solutions was obtained by performing two 4-hour peritoneal equilibration tests (PETs) with 3.86% glucose and 7.5% icodextrin as test solution, using an IPV of 1200 mL/m2and dextran 70 as volume marker. IPP was measured at two consecutive time points ( t = 0 and t = 240 minutes). Transcapillary ultrafiltration, net ultrafiltration, and marker clearance were calculated.PatientsIPP was established in 30 patients with median age of 4.5 years (range 1.0 – 14.9 years). Influence of dialysis solutions on IPP was studied in 9 children with median age of 4.2 years (range 1.7 – 10.9 years) and median treatment period of 12 months (range 5.6 – 122.3 months).ResultsMean IPP was 12.0 ± 6.5 cm H2O. Significant relations were found between the change in IPP and transcapillary ultrafiltration and body surface area during the PET with 3.86% glucose. No relations were seen during the PET with icodextrin.ConclusionsIPP was established in a large pediatric study group and was similar to previously published values of IPP in a small number of patients. Differences in fluid kinetics have different effects on the change in IPP during a 4-hour dwell period.

♦ Objectives To assess the efficacy and safety of icodextrin in Japanese patients and to investigate the relationship between net ultrafiltration (UF) during the long dwell and plasma oligosaccharides. ♦ Design Open-labeled clinical trial involving patients on continuous ambulatory peritoneal dialysis (CAPD) receiving icodextrin during the 12-hour long dwell for 6 weeks, preceded by and followed by a 2-week baseline period and a follow-up period during which 1.36% glucose was used for the 8-hour long dwell. ♦ Setting A prospective, randomized multicenter study done in tertiary medical centers. ♦ Patients 18 stable patients on CAPD for 3 months or longer. ♦ Main Outcomes Measures Net UF (in milliliters), UF rate (in milliliters per hour), plasma oligosaccharides, serum osmolarity (in milliosmoles per liter), peritoneal absorption of icodextrin, and peritoneal clearances of icodextrin, creatinine, and urea were assessed. Adverse events, laboratory findings, and vital signs were also monitored. ♦ Results Long-dwell net UF (544.4 ± 96.7 mL at day 3, p < 0.001; 309.4 ± 60.7 mL at week 4, p < 0.001; and 391.7 ± 61.1 mL at week 6, p< 0.001) and UF rate (48.2 ± 38.8 mL/hour at day 3, p < 0.001; 26.9 ± 22.1 mL/hr at week 4, p < 0.002; and 35.3 ± 22.9 mL/hr at week 6, p = 0.0002) were significantly greater during the icodextrin period than at baseline (-25.9 ± 46.0 mL and -2.2 ± 22.1 mL/hr, respectively). Plasma oligosaccharides reached steady state within 2 weeks, remained stable during the treatment period, and returned to baseline level 2 weeks after discontinuation of icodextrin. Serum osmolarity increased during the use of icodextrin by approximately 5 mOsm/L. No statistically significant relationship was found between plasma oligosaccharides and net UF. Peritoneal absorption of icodextrin (36.3% ± 5.1% at day 3,42.2% ± 5.9% at week 4, and 38.0% ± 6.3% at week 6) and peritoneal clearance of icodextrin (10.1 mL/minute at day 3,10.1 mL/min at week 4, and 10.3 mL/min at week 6) showed no major change over time. Serum sodium and serum chloride both decreased by 5 mEq/L with icodextrin but remained within the normal range during the treatment period and returned to baseline levels immediately after discontinuation. No serious adverse events were observed during the study. ♦ Conclusion The results of this study do not support the hypothesis that an increased blood oligosaccharide level and the concomitant elevation in serum osmolarity have a negative impact on peritoneal UF. Therefore, the increase in plasma oligosaccharides appears to be too small to be of clinical significance.

BACKGROUND To assess the need to adapt dietary prescriptions, we studied potential effects of increasing the dialysis dose by adding a daytime icodextrin dwell, in children on Nocturnal Intermittent Peritoneal Dialysis (NIPD), on peritoneal amino acids (AA) and albumin loss, AA, albumin, cholesterol and fibrinogen plasma levels and nutritional intake. METHODS A cross-over study in eight children (age 2-12 years) on NIPD at baseline (week 1). INTERVENTION to increase dialysis dose we added a daytime dwell with 1100 ml/m(2) icodextrin solution for a week (week 2). MAIN OUTCOME MEASURES peritoneal albumin loss (quantified by nephelometry) and AA loss (quantified by liquid chromatography mass spectrometry) in the last 72 h dialysate collections of weeks 1 and 2. On days 7 and 14, morning blood sample was taken for urea, creatinine, plasma AA levels, serum albumin, cholesterol and fibrinogen determination. Nutritional intake diaries were kept throughout the study period. RESULTS Weekly dialysis creatinine clearance increased from 35 to 65 l/1.73 m(2) (P

UNLABELLED Icodextrin (Extraneal) is a high molecular weight glucose polymer developed specifically for use as an alternative osmotic agent to dextrose during the once-daily long-dwell exchange in peritoneal dialysis (PD). Isosmotic 7.5% icodextrin solution induces transcapillary ultrafiltration (UF) by a mechanism resembling 'colloid' osmosis (unlike hyper-osmolar dextrose-based solutions, which induce UF by crystalline osmosis). In addition, absorption of icodextrin from the peritoneal cavity is relatively slow compared with that of dextrose; this results not only in UF of longer duration, but also a lower carbohydrate load compared with medium (2.5%) and strong (4.25%) dextrose exchanges. In randomised clinical trials of up to 2 years in duration, administration of icodextrin for the long (8- to 16-hour) overnight exchange in continuous ambulatory peritoneal dialysis (CAPD) or daytime exchange in automated peritoneal dialysis (APD) produced net UF which exceeded that with 1.5% and 2.5% dextrose solutions (thereby improving fluid balance), and was equivalent to that with 4.25% dextrose solution. Icodextrin also increased peritoneal clearances of creatinine and urea nitrogen compared with 2.5% dextrose solution. The increase in UF volume with icodextrin was enhanced in CAPD patients with high peritoneal membrane permeability (i.e. high and high-average transporters), maintained in the small number of patients followed-up for 2 years and sustained during episodes of peritonitis. Icodextrin reduced the percentage of patients with net negative UF in contrast to 1.5% and 2.5% dextrose and, in noncomparative studies, extended PD technique survival in patients who had failed dextrose-based dialysis. The use of icodextrin was also associated with some symptomatic improvements and health-related quality of life advantages, and no adverse effect on patient survival, compared with dextrose, although confirmation of these findings is ideally required in appropriately designed studies. The tolerability of icodextrin was generally similar to that of dextrose-based solutions in controlled clinical trials, although there was an approximate three-fold increase in the risk of new skin rash (5.5% vs 1.7%). However, reports of severe cutaneous hypersensitivity reactions remain rare; this possibility should not preclude the use of the polymer. CONCLUSION 7.5% icodextrin solution offers the first feasible alternative to conventional dextrose solutions for the once-daily long-dwell exchange in PD. It is effective, generally well tolerated and appears to be most useful in situations of reduced or inadequate UF with dextrose, including in high and high-average transporters, during episodes of peritonitis and patients who have failed dextrose-based dialysis.

Icodextrin is a new peritoneal dialysis fluid, with maltose polymers providing the osmotic drive, that may extend time on peritoneal dialysis in situations in which use of conventional glucose-based peritoneal dialysis fluid (Dianeal) has led to loss of ultrafiltration. Although cutaneous reactions have been reported, we report a new phenomenon of aseptic peritonitis that has arisen in our unit associated with icodextrin use.Icodextrin was first introduced in our unit in 1997 and was used extensively beginning in late 1999. From a combination of an observational study of 141 patients in our unit in whom icodextrin was used over 3.5 years and our unit 2000 and 2001 peritonitis audits, we identified an increase in the incidence of culture-negative peritonitis (CNP).The rate in 2000 of 12.3% rose to 17% in 2001, but this increase was seen only in patients on icodextrin (Percentage changes 2000 audit2001 audit: icodextrin patients, 14%--31% increase; Dianeal alone, 12%--10% increase; P0.05). Six patients were affected in the period 2000 to 2001 out of a total of 141 patients exposed to icodextrin (4.3%). Two index cases of relapsing CNP responded after withdrawal of the icodextrin. We then adopted a protocol of cessation and rechallenge with icodextrin when dealing with CNP, which successfully confirmed the phenomenon and led to resolution of relapsing CNP after icodextrin withdrawal. All these patients had been on icodextrin for some time, and none had had an immediate reaction or any skin reaction. Eosinophils were reported in the peritoneal effluent from two patients. All patients continued Dianeal without further CNP episodes.Icodextrin use carries the risk of CNP, and we suggest a cessation and rechallenge protocol in all patients on icodextrin who have CNP.

In a randomized, prospective, multicenter study, we compared the safety, efficacy, and metabolic effects of a 7.5% icodextrin solution (Extraneal) with a 2.27% glucose solution for long dwell exchanges in patients undergoing automated peritoneal dialysis. Thirty-nine stable patients on automated peritoneal dialysis were randomized to receive either icodextrin (n = 20) or glucose 2.27% solution (n = 19). The study included a 2-week baseline period followed by a 12-week icodextrin treatment phase and a 2-week follow-up period when switching back to glucose. The average net ultrafiltration during the long dwell period was 278 +/- 43 mL/d for the icodextrin group and -138 +/- 81 mL/d for the control group (P < 0.001). The higher ultrafiltration volume with icodextrin was associated with higher creatinine (2.59 +/- 0.09 mL/min versus 2.16 +/- 0.11 mL/min) and urea (2.67 +/- 0.09 mL/min versus 2.28 +/- 0.12 mL/min) peritoneal clearances for the long dwell (both P < 0.001). Ultrafiltration rate per mass of carbohydrate absorbed was +5.2 +/- 1.2 microL/min/g in the icodextrin group and -5.5 +/- 2.8 microL/min/g in the glucose group (P < 0.001). In the icodextrin group, there was a decrease in serum sodium and chloride compared with baseline (P < 0.01). Total dialysate sodium removal increased in the icodextrin group from 226.7 mEq to 269.6 mEq (week 12, P < 0.001). Serum alpha-amylase activity decreased from 103 U/L to 16 U/L (P < 0.001). The total icodextrin plasma levels reached a steady-state concentration of 6,187 +/- 399 mg/L after 1 week of treatment. Urine volume and residual renal function were not specifically affected by icodextrin compared with glucose. None of the laboratory changes resulted in any reported clinically meaningful side effect. Icodextrin produced increased, sustained ultrafiltration during the long dwell period, increasing (convective) peritoneal clearance and sodium removal in automated peritoneal dialysis patients.

The peritoneal equilibration test (PET) is an important tool for evaluating peritoneal membrane characteristics. The polyglucose icodextrin induces ultrafiltration caused by colloid osmosis through the small pores of the peritoneal membrane and therefore is especially effective during long dwell times. The main indications for polyglucose solutions are daytime dwells in patients on automated peritoneal dialysis and nighttime exchanges in continuous ambulatory peritoneal dialysis (CAPD) patients. In CAPD patients, PET is started immediately after the icodextrin exchange. Therefore, we performed two PETs in each of 15 CAPD patients. PET post-1.36% glucose was performed immediately after a preceding exchange with 2 L of 1.36% glucose dialysate solution (dwell time, 10 hours). PET postpolyglucose was started immediately after a preceding exchange with 2 L of 7.5% icodextrin solution (dwell time, 10 hours). The dialysate to plasma (D/P) ratio of creatinine, phosphate, and sodium during PET postpolyglucose was significantly greater than during PET post-1.36% glucose at 1, 2, 3, and 4 hours of dwell time. The quotient of dialysate glucose at 1, 2, and 4 hours of dwell time to dialysate glucose at 0 dwell time was significantly lower in PET postpolyglucose compared with PET post-1.36% glucose. In the case of creatinine, phosphate, and glucose, PET postpolyglucose curves tended to be steeper than those of PET post-1.36% glucose during the first hour of dwell time, whereas both curves were parallel between 1 and 4 hours of dwell time. The course of D/P ratio curves of urea nitrogen, protein, and albumin was nearly identical between PET postpolyglucose and PET post-1.36% glucose. In a subgroup of 5 patients, D/P ratios of creatinine and phosphate were also greater in PET postpolyglucose compared with PET performed after a long dwell with 2.27% glucose solution. Before a scheduled PET, CAPD patients using icodextrin solution during the nighttime should perform their nighttime exchange with conventional glucose solution.

Effect of peritonitis on peritoneal transport characteristics: Glucose solution versus polyglucose solution. Background Peritonitis is a common clinical problem and contributes to the high rate of technique failure in continuous ambulatory peritoneal dialysis treatment. The present study investigated the effect of peritonitis on peritoneal fluid and solute transport characteristics using glucose and polyglucose (icodextrin) solutions. Methods A four-hour dwell was performed in 32 Sprague-Dawley rats (8 rats in each group), with 131 I albumin as an intraperitoneal volume marker. Peritonitis was induced by an intraperitoneal injection of 2 mL lipopolysaccharide (100 μg/mL phosphate-buffered saline) four hours before the dwell. Each rat was intraperitoneally infused with 25 mL of 3.86% glucose [glucose solution control group (Gcon) and glucose solution peritonitis group (Gpts)] or 7.5% icodextrin solution [icodextrin solution control group (Pgcon) and icodextrin peritonitis group (PGpts)]. Results Net ultrafiltration was significantly lower (by 44%) in the Gpts as compared with the Gcon group, but was significantly higher (by 138%) in the PGpts as compared with the PGcon group. The peritoneal fluid absorption rate, including the direct lymphatic absorption rate, was significantly increased (by 78%) in the Gpts group as compared with the Gcon group. However, the total fluid absorption did not differ between the PGpts and the PGcon groups. The dialysate osmolality decreased much faster in the Gpts group as compared with the Gcon group, resulting in significantly lower (by 9%) transcapillary ultrafiltration in the Gpts group. In contrast, the dialysate osmolality increased faster in the PGpts group as compared with the PGcon group, resulting in higher (by 40%) transcapillary ultrafiltration in the PGpts group. The in vitro increase in dialysate osmolality was also higher in the PGpts group as compared with the PGcon group. The solute diffusive transport rates were, in general, increased in the two peritonitis groups as compared with their respective control groups. Conclusions Our results suggest the following: ( 1 ) Peritonitis results in decreased net ultrafiltration using glucose solution caused by (a) decreased transcapillary ultrafiltration and (b) increased peritoneal fluid absorption. ( 2 ) Ultrafiltration induced by the icodextrin solution appears to be related to the increase in dialysate osmolality (mainly because of the degradation of icodextrin). ( 3 ) Peritonitis results in increased degradation of icodextrin and a faster increase in dialysate osmolality and therefore better ultrafiltration, whereas the fluid absorption rate does not change. ( 4 ) Peritonitis results in increased peritoneal diffusive permeability.

Uterine leiomyomas are by far the most common benign genital tumors. The prevalence rates vary from 20% to 50%. Myomectomy is a standard surgical treatment and is prescribed for patients who wish to preserve their fertility. The laparoscopic approach allows a shorter hospital stay, faster recovery, less intraoperative blood loss, less postoperative pain, and possibly fewer adhesions than abdominal myomectomy when performed by skilled surgeons. Myomectomy is associated with the risk of excessive blood loss and adhesions formation. Reports of disseminated intravascular coagulation complicating this type of surgery are rare, and no prior cases have been reported in the literature after the use of 4% icodextrin. Randomized trials support the use of absorbable adhesion barriers to reduce adhesion formation. A case of disseminated intravascular coagulation after laparoscopic multiple myomectomy with the use of 4% icodextrin solution is described.

BMC surgery 13, 34 (2013). doi:10.1186/1471-2482-13-34, Published by BioMed Central, London

♦BackgroundPeritoneal dialysis (PD) solutions containing icodextrin as the osmotic agent have advantages during long dwells. The glucose polymers that constitute icodextrin are a heterogeneous mix of molecules with a polydispersity [ratio of weight-average to number-average molecular weight (Mw/Mn)] of approximately 2.6. The present study evaluates whether modifications in the polydispersity and concentration of glucose polymers can improve ultrafiltration (UF) without an associated increase in carbohydrate absorption (CA).♦MethodsComputer simulations using a three-pore model of peritoneal transport during a long dwell in PD patients predict that, in general, compared with 7.5% icodextrin, glucose polymers with a Mw greater than or equal to 7.5 kDa, a polydispersity less than 2.6, and concentrations greater than 7% could achieve higher UF without higher CA. Based on the simulations, we hypothesized that, compared with 7.5% icodextrin, glucose polymers with a Mw of 18 – 19 kDa and a polydispersity of 2.0 at 11% concentration could achieve higher UF without a higher CA. We tested this hypothesis in experimental studies using 8-hour dwells in New Zealand White rabbits. In those studies, UF was measured by complete fluid collection, and CA was measured by subtracting the total carbohydrate in the collected fluid from the carbohydrate initially infused.♦ResultsThe UF was higher with 11% 19 kDa glucose polymer than with 7.5% icodextrin (mean ± standard deviation: 89 ± 31 mL vs 49 ± 15 mL; p = 0.004) without higher CA (5.2 ± 0.9 g vs 5.0 ± 0.9 g, p = 0.7). Similar results were seen with the 11% 18 kDa glucose polymer, which, compared with 7.5% icodextrin, resulted in higher UF (mean ± standard deviation: 96 ± 18 mL vs 66 ± 17 mL; p < 0.001) without higher CA (4.8 ± 0.7 g vs 5.2 ± 0.6 g, p = 0.2).♦ConclusionsThe findings demonstrate that, compared with 7.5% icodextrin solution, long-dwell PD solutions containing 11% glucose polymers with a Mw of 18–19 kDa and a polydispersity of 2.0 can provide higher UF without higher CA.

Background Urinary retention is a recognised complication of laparoscopic surgery. Previous work showed an association with 4% icodextrin solution and urinary retention. Aims To determine the incidence of urinary retention following laparoscopic gynaecological surgery with or without the use of 4% icodextrin. Methods A prospective observational study of 147 women undergoing laparoscopic gynaecological surgery for benign pathology. Women had their planned laparoscopic procedure and either received icodextrin solution or nothing as determined by their treating surgeon at the time of the operation. Results From May 2011 to February 2012, 147 women were approached to participate in the study; of whom, 124 women were included: 62 received icodextrin and 62 did not. The women in the non-icodextrin group were significantly older (P = 0.007) and had a higher BMI (P = 0.03) than those in the icodextrin group. Following surgery, 27/124 (21.8%) women had post-operative urinary retention. Icodextrin was associated with significantly more urinary retention (P = 0.017), but did not extend hospital admission significantly (P = 0.14). The administration of icodextrin was associated with resection of moderate- or severe-stage endometriosis involving multiple surgical sites, whereas women in the non-icodextrin group were more likely to be having a hysterectomy. Conclusions In this non-randomised study, there were significantly more women with post-operative urinary retention when icodextrin was used; however, this did not contribute to an extended hospital admission. While there may be confounding factors, women receiving icodextrin should be warned of the possibility of urinary retention post-operatively, but that this is unlikely to affect their stay in hospital.

Although icodextrin solution has been highlighted in the fluid management compared to glucose-based solutions, proof of a beneficial effect of icodextrin solution on residual renal function (RRF) is lacking. We conducted a multicenter prospective randomized controlled open-label trial to investigate whether icodextrin solution can preserve RRF. One hundred patients with urine volume ≥750 mL/day from 8 centers in Korea were randomly assigned to receive 1 exchange of icodextrin solution for a ≥8 hour-dwell time and 2 exchanges of 1.5% glucose-based biocompatible neutral pH solution or 1 exchange of ≥2.5% and 2 exchanges of 1.5% glucose-based biocompatible solutions. Using mixed-effects general linear models, we analyzed changes in residual glomerular filtration rate (GFR) and daily urine volume at 1 year. Forty-nine patients were assigned to the icodextrin group and 51 to the glucose solution group. During follow-up, the slope of the decline in residual GFR was −0.170 mL/min/month/1.73 m2 in the icodextrin group, while it was −0.155 mL/min/month/1.73 m2 in the glucose solution group (95% confidence interval [CI], −0.06 to 0.10; P = 0.701). Daily urine volume decreased faster in the glucose solution group than in the icodextrin group (−31.02 vs −11.88 mL per month; 95% CI, −35.85 to −2.44; P = 0.025). Results were consistent when we analyzed using intention-to-treat and per protocol principles. There were no differences in fluid status, peritoneal ultrafiltration, and peritoneal transport between groups during follow-up. This study clearly showed that icodextrin solution preserves residual urine volume better than glucose solution.

Adhesive small bowel obstruction is a frequent cause of hospital admission. Water soluble contrast studies may have diagnostic and therapeutic value and avoid challenging demanding surgical operations, but if bowel ischemia is suspected, prompt surgical intervention is mandatory. A 58-year-old patient was operated for extensive adhesive small bowel obstruction after having had two previous laparotomies for colorectal surgery, and had a complex clinical course with multiple operations and several complications. Different strategies of management have been adopted, including non-operative management with the use of hyperosmolar water soluble contrast medium, multiple surgical procedures, total parenteral nutrition (TPN) support, and finally use of antiadherences icodextrin solution. After 2 years follow-up the patient was doing well without presenting recurrent episodes of adhesive small bowel obstruction. For patients admitted several times for adhesive small bowel obstruction, the relative risk of recurring obstruction increases in relation to the number of prior episodes. Several strategies for non-operative conservative management of adhesive small bowel obstruction have already addressed diagnostic and therapeutic value of hyperosmolar water soluble contrast. According to the most recent evidence-based guidelines, open surgery is the preferred method for surgical treatment of strangulating adhesive small bowel obstruction as well as after failed conservative management. Research interest and clinical evidence are increasing in adhesions prevention. Hyaluronic acid-carboxycellulose membrane and icodextrin may reduce incidence of adhesions.

Peritoneal dialysis (PD) has achieved its current position as the most commonly used home-based dialysis therapy--and with patient survival equal to that seen with hemodialysis--despite the use of glucose-based dialysis solutions with high concentrations of glucose, glucose degradation products and lactate, high osmolality, and low pH, features that are harmful both for the peritoneum and the patient. Newer PD solutions with alternative buffers, a higher pH and fewer glucose degradation products, or ones that contain icodextrin or amino acids as osmotic agents, have been introduced in many countries and have been shown to improve peritoneal membrane health and viability. Icodextrin solution enhances fluid and sodium removal, and the once-daily use of icodextrin and/or amino acid solutions can lessen the harmful effects caused by the exposure of the peritoneal membrane to glucose. However, whether the newer PD solutions improve patient survival over the older solutions is not clear. Use of PD therapy, with or without the newer PD solutions, is associated with an improvement in patient survival that is equivalent to that obtained with hemodialysis. Therefore, the conventional glucose-based solutions--despite their known negative features--continue to have a well-established role in PD therapy, particularly in the many countries where the newer PD solutions are not easily available.

Five patients with advanced colorectal and gastric carcinoma with peritoneal deposits were treated by continuous weekdays intraperitoneal (i.p.) instillation of 5-fluorouracil (5-FU) 200 mg m-2 day-1 in a novel dialysate solution that ensures maximal exposure of peritoneal areas liable to bear tumours for 24 h. A solution of icodextrin, a glucose polymer, in a 21 twin-bag delivery system allowed a single daily exchange and demonstrated the feasibility of long-term continuous ambulatory treatment with up to 17.4 g of 5-FU, delivered intraperitoneally, in this initial study. During the entire study, there were 235 fluid exchanges or 470 connections and disconnections and no bacterial peritonitis or exit site infection were observed. There was no treatment-associated toxicity worse than WHO grade 2. Drug concentrations in both peritoneal and plasma compartments followed a first-order model with similar half-life value of 1.3 h. 5-FU pharmacokinetic parameters (half-life values, total body clearance, peritoneal clearance and pharmacological advantage of the i.p. route) with this novel icodextrin carrier solution were similar to those obtained in other referenced pharmacokinetic studies with other carrier solutions (dextrose dialysate and lactated Ringer's solutions). This confirms that icodextrin solution is physiologically neutral, drug compatible and allows adequate dwell times with constant fluid balance for long-term continuous intraperitoneal chemotherapy. The pharmacokinetic parameters from this study will be used to design a loading dose infusion schedule in an attempt to maintain steady-state i.p. 5-FU levels in a new multicentre phase I trial.

Summary Diuretic-resistant congestive heart failure in the form of type 2 cardiorenal syndrome is a problem of growing significance in everyday clinical practice because of high morbidity and mortality. There has been scant progress in the treatment of overhydration, the main cause of symptoms in this group of patients. The aim of our review is to present recent advances in the ultrafiltration therapy of congestive heart failure, with special attention to the new dedicated device for extracorporeal isolated ultrafiltration, as well as modifications of peritoneal dialysis in the form of peritoneal ultrafiltration with icodextrin solution and incremental peritoneal dialysis. Technical and clinical features, costs and potential risks of available devices for isolated ultrafiltration are presented. This method should be reserved for patients with true diuretic resistance as part of a more complex strategy aiming at the adequate control of fluid retention. Peritoneal ultrafiltration is presented as a viable alternative to extracorporeal ultrafiltration because of medical and psychosocial benefits of home-based therapy, lower costs and more effective daily ultrafiltration. In conclusion, large, properly randomized and controlled clinical trials with long-term follow-up will be essential in assessing the logistics and cost-effectiveness of both methods. Most importantly, however, they should be able to evaluate the impact of both methods on preservation of renal function and delaying the progression of heart failure by interrupting the vicious circle of cardiorenal syndrome. Our review is supplemented with the case report of the use of peritoneal ultrafiltration with a single 12-hour nighttime icodextrin exchange as a life-saving procedure in a patient with congestive heart failure resistant to pharmacological treatment.

Background Many studies have suggested clinical benefits of icodextrin in peritoneal dialysis (PD) patients regarding fluid management, glycaemic control and metabolic improvement. However, reports on whether icodextrin can improve patient and technique survival is sparse. Methods A total of 2163 patients from 54 centres in Korea who initiated PD from July 2003 to December 2006 were enrolled. Outcomes data were retrieved retrospectively from the Baxter Korea database. Among these patients, 641 patients who had been prescribed icodextrin for >50% of their PD duration were defined as the 'icodextrin' group and the remaining 1522 patients as the 'non-icodextrin' group. Propensity score matching yielded 640 matched pairs of patients. We compared all-cause mortality and technique failure rates between the two groups. Results There were no significant differences in age, gender, diabetes, cardiovascular comorbidity, socioeconomic status, biocompatible solution use in short dwells or centre experience between the two groups. Death occurred in 92 (14.4%) patients in the icodextrin group compared with 128 (20.0%) in the non-icodextrin group [hazard ratio (HR), 0.69; 95% confidence interval (CI), 0.53-0.90; P = 0.006]. In addition, icodextrin use was associated with a significantly lower risk of technique failure (HR, 0.60; 95% CI, 0.40-0.92; P = 0.018). The icodextrin group had fewer technique failures due to non-compliance compared with the non-icodextrin group whereas peritonitis- or ultrafiltration failure-related technique failure was not different between the two groups. Conclusion This study further supports previous findings of long-term utilization of icodextrin solution improving patient and technique survival in PD patients. To confirm these results, a large randomized prospective study is warranted.

Background. Peritoneal dialysis (PD) is associated with a depression of T cell function, as suggested by the impaired production of cytokines by Th cells collected from PD patients. Although treatment biocompatibility could be implicated in this immune dysfunction, it has been poorly investigated, thus far. Therefore, we undertook a study aiming to analyze the effects of different peritoneal dialysis fluids on the Th1/Th2 balance in PD patients. Methods. Twenty three patients on continuous ambulatory peritoneal dialysis (CAPD) were evaluated. Seven patients were on CAPD with icodextrin solution (ICO-PD), seven with glucose and lactate/bicarbonate-buffered solution (LAC/BIC-PD), and nine with glucose and lactate-buffered solution (LAC-PD). The Th1/Th2 balance was eval- uated by measuring IFN- (Th1 subset) and IL-4 (Th2 subset), both in circulating and peritoneum-derived Th lymphocytes unstimulated or stimulated by phytohemoagglutinin (PHA). Moreover inflammatory, nutritional and dialysis-related parameters were recorded. Eight normal subjects comprised the control group (CON). Results. Circulating T cells: IFN- was significantly lower in the LAC-PD group (p

Gynaecological laparoscopic surgery outcomes can be compromised by the formation of de novo adhesions. This randomized, double-blind study was designed to assess the efficacy and safety of 4% icodextrin solution (Adept(®)) in the reduction of de novo adhesion incidence compared to lactated Ringer's solution (LRS).Patients undergoing laparoscopic surgery for removal of myomas or endometriotic cysts were treated with randomized solution as an intra-operative irrigant and 1l post-operative instillate. De novo adhesion incidence (number of sites with adhesions), severity and extent were independently scored at a second-look procedure and the efficacy of the two solutions compared. The effect of surgical covariates on adhesion formation was also investigated. Initial exploratory analysis of individual anatomical sites of clinical importance was progressed. RESULTS Of 498 patients randomized, 330 were evaluable (160 LRS--75% myomectomy/25% endometriotic cysts; 170 Adept--79% myomectomy/21% endometriotic cysts). At study completion, 76.2% LRS and 77.6% Adept had ≥ 1 de novo adhesion. The mean (SD) number of de novo adhesions was 2.58 (2.11) for Adept and 2.58 (2.38) for LRS. The treatment effect difference was not significant (P = 0.909). Assessment of surgical covariates identified significant influences on the mean number of de novo adhesions regardless of treatment, including surgery duration (P = 0.048), blood loss in myomectomy patients (P = 0.019), length of uterine incision in myomectomy patients (P0.001) and number of suture knots (P0.001). There were 15 adverse events considered treatment-related in the LRS patients (7.2%) and 18 in the Adept group (8.3%). Of 17 reported serious adverse events (9 LRS; 8 Adept) none were considered treatment-related.The study confirmed the safety of Adept in laparoscopic surgery. The proportion of patients with de novo adhesion formation was considerably higher than previous literature suggested. Overall there was no evidence of a clinical effect but various surgical covariates including surgery duration, blood loss, number and size of incisions, suturing and number of knots were found to influence de novo adhesion formation. The study provides direction for future research into adhesion reduction strategies in site specific surgery.

Background: Adhesion is a common complication of gynecology surgery so different barrier agents and solutions have been used during these operations to separate and protect tissues from adhesion after surgery. Adept is one of these solutions that have been postulated to reduce the chance of adhesion following gynecolgy surgery.Objective: To evaluate the effect of 4% icodextrin in reducing adhesion formation in comparing with sterile water and human amniotic fluid in rabbits.Materials and Methods: In this prospective experimental study 30 white Newzealand female rabbits were selected and randomized in to three treatment groups. The rabbits were anesthetized and an abdominal incison was made, uterine horns were abrated with gauze until bleeding occurred. Before closing the abdomen, the traumatized area was irrigated either by 30cc of sterile water, 30cc of 4% Adept or 30cc of human amniotic fluid. The solutions were labeled only as solutions A (steriel water), B (icodextrin), or C (human amniotic fluid). On the seventh day after surgery, second laparotomy was performed to determine and compare adhesion formation in rabbits.Results: There was significant difference between mean score of adhesions in 4% icodextrin group (2.1±0.70) in comparison to sterile water group (10.4±0.60) and amniotic fluid group (8.7±0.84). But the difference between mean score of adhesions in amniotic fluid group in comparison to sterile water group was not significant (8.7±0.84) versus (10.4±0.60).Conclusion: The use of 4% icodextrin solution was more effective than human amniotic fluid and sterile water in reducing adhesion formation in a gynecological surgery model in rabbits

Objective A pilot randomized controlled clinical multicentre trail was established to compare intraperitoneal 4% icodextrin (ID) solution with lactated Ringer’s solution (LRS) on adhesion formation after Hartmann’s procedure. The adhesiolysis surgery time during Hartman’s reversal was used as a marker of the severity of adhesions. Method Patients scheduled for Hartmann’s resection were randomized at surgery to either of the two study solutions used as an irrigant during the operation and instilled (1000 ml) at the end of surgery. During the reversal procedure, the time for small bowel adhesiolysis was recorded. Results On completion of 17 eligible patients, an interim analysis was performed. There were no complications following the use of 4% ID solution. The mean (SD) total adhesiolysis times in patients treated with 4% ID solution and LRS were 30.8 (18.0) min and 47.6 (45.7) min, respectively. The mean reduction of 16.8 min, although greater than expected, was not statistically significant (P = 0.33) because of the large variance in adhesiolysis times. Further statistical analysis showed that to achieve significance for the observed differences and variance, a minimum of 240 patients in each group would be required. Conclusion Icodextrin treatment resulted in a decreasing trend in adhesiolysis time. The use of 4% ID solution in peritonitis patients seemed to be safe. Because of larger than expected variations in adhesiolysis times, this pilot study was underpowered to meet the study end-point and further statistical modelling estimated that significance cannot be reached within a reasonable time scale. Other models should be used to evaluate the efficacy of anti-adhesive agents.

Standard peritoneal dialysis (PD) solutions with low pH and containing high concentrations of lactate and glucose have been demonstrated to negatively affect the peritoneal membrane, mesothelial cell viability, residential peritoneal cells, and also to inhibit phagocytic functions. An increasing body of experimental evidence supports the idea that the peritoneal hypervascularization and fibrosis observed in long-term PD are causally related to the acute and chronic toxicity of conventional PD solutions. A Physioneal (lactate/bicarbonate mixed buffer pH 7–7.4), Physioneal, Extraneal (7.5% icodextrin), Nutrineal (1.1% amino-acid-containing solution) regimen, for example, offers a significant reduction in carbohydrate load (approximately 40–50%), lower exposure to and absorption of glucose degradation products, reduced oxidative stress, and improved volume control when compared with a first-generation DDDD (4 × Dianeal) regimen. The positive aspects of each solution that we have observed in our patients allow a recommendation on the potential benefit of using these solutions in children treated with PD. In fact, data from the literature as well as the results of the studies reported in this paper show that in children the application of neutral pH bicarbonate/lactate-buffered solution for the standard nighttime APD prescription, icodextrin solution for a long daytime dwell, and AA-based solution in malnourished patients is safe and effective. Extended clinical trials should be encouraged to better define the PD schedules for the combined use of these solutions that may be associated with the best clinical efficacy and the highest level of biocompatibility.

The use of icodextrin as an osmotic agent in solutions for peritoneal dialysis (PD) has important cardiovascular effects related with better control of extracellular volume. Among them, reduction of arterial pressure and an improvement in echocardiographic parameters stand out. In diabetic patients, icodextrin has additional potential advantages related with better metabolic control. In a multicenter, open-label randomized controlled trial, the effects of icodextrin solutions were compared to glucose solutions on echocardiographic, electrocardiographic, and blood pressure changes in diabetic patients on PD. Two phases were noted in the follow-up. In the early phase (6 months), reduction in ambulatory blood pressure (ABP) and left ventricular end diastolic diameter were found in the icodextrin group. These changes correlated with changes in body fluids. In the late phase (12 months), a trend towards baseline values in ABP was seen. Changes in inferior vena cava diameter and in low frequency R-R variability spectral analysis in the icodextrin group suggest that icodextrin increases circulating blood volume and sympathetic tone, probably by accumulation of icodextrin metabolites in the bloodstream and improvement in diabetic neuropathy as a result of lower peritoneal glucose absorption. The effects of icodextrin in diabetic patients were related to better fluid management and metabolic control.

Icodextrin, a mixture of polysaccharides of alpha-(1 --4) polyglucopyranose having 10% branched chains, is clinically available as a D-glucose substitute for peritoneal dialysis (PD). Due to the high intraperitoneal retention time of this glucose polymer (GP), water transport from the vessels to the peritoneal cavity is prolonged even in PD patients with high peritoneal permeability. The purpose of this study was to elucidate why 7.5% icodextrin solution has such a broad distribution of molecular weights. A gel permeation chromatography study indicated that the average molecular weight was about 18.0 kDa in terms of number average (Mn) and 31.3 kDa in terms of weight average (Mw), respectively, resulting in a polydispersity index (Mn/Mw) of 1.74. Five fractions of GP having Mn values of 41.3, 19.3, 8.3, 3.8, and 2.1 kDa, respectively, produced 0.24, 0.49, 0.50, 0.08, and 0.03 mOsmol/kg H2O of colloid osmotic pressure. Water transport through a membrane having a molecular cutoff of 15 kDa was simulated using the mass transfer coefficient and reflection coefficient for each fraction. Fractions with Mn values of 19.3 and 8.3 kDa contributed to water transport dominantly (approximately 76%), while only 18%, 5%, and 3% of total water removal was contributed by fractions with Mn values of 41.3, 3.8 and 2.1 kDa, respectively. As a result of enzymatic degradation for 10 h by 2, 10, or 20 U/l alpha-amylase, a decrease in the high molecular weight zone (40-60 kDa) and a rise in the low molecular weight zone (1-2 kDa) were seen with few change in the distribution profile between 4 and 30 kDa. These results suggested that fractions in the molecular range between 8.3 and 19.3 kDa, where the distribution profile was less influenced by enzymatic degradation, preferably contributed to water transport.

Severe vulval edema after laparoscopic ovarian cystectomy with instillation of adhesion-prevention solution (4% icodextrin) is a rare complication. A 17-year-old girl was readmitted to the hospital 2 days after laparoscopic ovarian cystectomy with massive vulval swelling, pain, and anxiety. Gross swelling was potentially caused by accumulation of fluid 4% icodextrin in the labia. The condition resolved spontaneously with application of ice packs and bed rest. Possible mechanisms of this complication are discussed as is the importance of adequate counseling and consent before surgery when adhesion prevention solutions are to be administered.