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Introduction Atrial fibrillation is highly prevalent in patients on chronic dialysis. It is unclear whether anticoagulant therapy for stroke prevention is beneficial in these patients. Vitamin K-antagonists (VKA) remain the predominant anticoagulant choice. Importantly, anticoagulation remains inconsistently used and a possible benefit remains untested in randomised clinical trials comparing oral anticoagulation with no treatment in patients on chronic dialysis. The Danish Warfarin-Dialysis (DANWARD) trial aims to investigate the safety and efficacy of VKAs in patients with atrial fibrillation on chronic dialysis. The hypothesis is that VKA treatment compared with no treatment is associated with stroke risk reduction and overall benefit. Methods and analysis The DANWARD trial is an investigator-initiated trial at 13 Danish dialysis centres. In an open-label randomised clinical trial study design, a total of 718 patients with atrial fibrillation on chronic dialysis will be randomised in a 1:1 ratio to receive either standard dose VKA targeting an international normalised ratio of 2.0–3.0 or no oral anticoagulation. Principal analyses will compare the risk of a primary efficacy endpoint, stroke or transient ischaemic attack and a primary safety endpoint, major bleeding, in patients allocated to VKA treatment and no treatment, respectively. The first patient was randomised in October 2019. Patients will be followed until 1 year after the inclusion of the last patient. Ethics and dissemination The study protocol was approved by the Regional Research Ethics Committee (journal number H-18050839) and the Danish Medicines Agency (case number 2018101877). The trial is conducted in accordance with the Helsinki declaration and standards of Good Clinical Practice. Study results will be disseminated to participating sites, at research conferences and in peer-reviewed journals., Introduction Atrial fibrillation is highly prevalent in patients on chronic dialysis. It is unclear whether anticoagulant therapy for stroke prevention is beneficial in these patients. Vitamin K-antagonists (VKA) remain the predominant anticoagulant choice. Importantly, anticoagulation remains inconsistently used and a possible benefit remains untested in randomised clinical trials comparing oral anticoagulation with no treatment in patients on chronic dialysis. The Danish Warfarin-Dialysis (DANWARD) trial aims to investigate the safety and efficacy of VKAs in patients with atrial fibrillation on chronic dialysis. The hypothesis is that VKA treatment compared with no treatment is associated with stroke risk reduction and overall benefit. Methods and analysis The DANWARD trial is an investigator-initiated trial at 13 Danish dialysis centres. In an open-label randomised clinical trial study design, a total of 718 patients with atrial fibrillation on chronic dialysis will be randomised in a 1:1 ratio to receive either standard dose VKA targeting an international normalised ratio of 2.0-3.0 or no oral anticoagulation. Principal analyses will compare the risk of a primary efficacy endpoint, stroke or transient ischaemic attack and a primary safety endpoint, major bleeding, in patients allocated to VKA treatment and no treatment, respectively. The first patient was randomised in October 2019. Patients will be followed until 1 year after the inclusion of the last patient. Ethics and dissemination The study protocol was approved by the Regional Research Ethics Committee (journal number H-18050839) and the Danish Medicines Agency (case number 2018101877). The trial is conducted in accordance with the Helsinki declaration and standards of Good Clinical Practice. Study results will be disseminated to participating sites, at research conferences and in peer-reviewed journals. Trial registration numbers NCT03862859, EUDRA-CT 2018-000484-86 and CTIS ID 2022-502500-75-00.

Introduction Fluid overload is a major challenge in hemodialysis patients and might cause hypervolemia. We speculated that hemodialysis patients reaching dry weight could have undetected hypervolemia and low hemoglobin (Hb) concentration (g/dL) due to hemodilution. Methods The study included hemodialysis patients (n = 22) and matched healthy controls (n = 22). Blood volume, plasma volume, red blood cell volume, and total Hb mass were determined using a carbon monoxide (CO)-rebreathing method in hemodialysis patients reaching dry weight and controls. Blood volume measurements were also obtained by a dual-isotope labeling technique in a subgroup for validation purposes. Findings In the hemodialysis group, the median specific blood volume was 89.3 mL/kg (interquartile range [IQR]: 76.7–95.4 mL/kg) and was higher than in the control group (79.9 mL/kg [IQR: 70.4–88.0 mL/kg]; p < 0.037). The median specific plasma volume was 54.7 mL/kg (IQR: 47.1–61.0 mL/kg) and 44.0 mL/kg (IQR: 38.7–49.5 mL/kg) in the hemodialysis and control groups, respectively (p < 0.001). Hb concentration was lower in hemodialysis patients (p < 0.001), whereas no difference in total Hb mass was observed between groups (p = 0.11). A correlation was found between blood volume measured by the CO-rebreathing test and the dual-isotope labeling technique in the control group (r = 0.83, p = 0.015), but not the hemodialysis group (r = 0.25, p = 0.60). Discussion The hemodialysis group had increased specific blood volume at dry weight due to high plasma volume, suggesting a hypervolemic state. However, correlation was not established against the dual-isotope labeling technique underlining that the precision of the CO-rebreathing test should be further validated. The total Hb mass was similar between hemodialysis patients and controls, unlike Hb concentration, which emphasizes that Hb concentration is an inaccurate marker of anemia among hemodialysis patients, Introduction: Fluid overload is a major challenge in hemodialysis patients and might cause hypervolemia. We speculated that hemodialysis patients reaching dry weight could have undetected hypervolemia and low hemoglobin (Hb) concentration (g/dL) due to hemodilution. Methods: The study included hemodialysis patients (n = 22) and matched healthy controls (n = 22). Blood volume, plasma volume, red blood cell volume, and total Hb mass were determined using a carbon monoxide (CO)-rebreathing method in hemodialysis patients reaching dry weight and controls. Blood volume measurements were also obtained by a dual-isotope labeling technique in a subgroup for validation purposes. Findings: In the hemodialysis group, the median specific blood volume was 89.3 mL/kg (interquartile range [IQR]: 76.7–95.4 mL/kg) and was higher than in the control group (79.9 mL/kg [IQR: 70.4–88.0 mL/kg]; p < 0.037). The median specific plasma volume was 54.7 mL/kg (IQR: 47.1–61.0 mL/kg) and 44.0 mL/kg (IQR: 38.7–49.5 mL/kg) in the hemodialysis and control groups, respectively (p < 0.001). Hb concentration was lower in hemodialysis patients (p < 0.001), whereas no difference in total Hb mass was observed between groups (p = 0.11). A correlation was found between blood volume measured by the CO-rebreathing test and the dual-isotope labeling technique in the control group (r = 0.83, p = 0.015), but not the hemodialysis group (r = 0.25, p = 0.60). Discussion: The hemodialysis group had increased specific blood volume at dry weight due to high plasma volume, suggesting a hypervolemic state. However, correlation was not established against the dual-isotope labeling technique underlining that the precision of the CO-rebreathing test should be further validated. The total Hb mass was similar between hemodialysis patients and controls, unlike Hb concentration, which emphasizes that Hb concentration is an inaccurate marker of anemia among hemodialysis patients.

Introduction Patients receiving haemodialysis are at increased risk of arrhythmias and sudden cardiac death, but data on arrhythmia burden and the pathophysiology remain limited. Among potential risk factors, hypoglycaemia is proposed as a possible trigger of lethal arrhythmias. The development of implantable loop recorders (ILR) and continuous glucose monitoring (CGM) enables long-term continuous ECG and glycaemic monitoring. The current article presents the protocol of a study aiming to increase the understanding of arrhythmias and risk factors in patients receiving haemodialysis. The findings will provide a detailed exploration of the burden and nature of arrhythmias in these patients including the potential association between hypoglycaemia and arrhythmias. Methods and analysis The study is an investigator-initiated, prospective, multicentre cohort study recruiting 70 patients receiving haemodialysis: 35 with diabetes and 35 without diabetes. Participants are monitored with ILRs and CGM for 18 months follow-up. Data collection further includes a monthly collection of predialysis blood samples and dialysis parameters. The primary outcome is the presence of clinically significant arrhythmias defined as a composite of bradycardia, ventricular tachycardia, or ventricular fibrillation. Secondary outcomes include the characterisation of clinically significant arrhythmias and other arrhythmias, glycaemic characteristics, and mortality. The data analyses include an assessment of the association between arrhythmias and hypoglycaemia and hyperglycaemia, baseline clinical variables, and parameters related to kidney failure and the haemodialysis procedure. Ethics and dissemination The study has been approved by the Ethics Committee of the Capital Region of Denmark (H-20069767). The findings will be presented at national and international congresses as well as in international peer-reviewed scientific journals., Introduction Patients receiving haemodialysis are at increased risk of arrhythmias and sudden cardiac death, but data on arrhythmia burden and the pathophysiology remain limited. Among potential risk factors, hypoglycaemia is proposed as a possible trigger of lethal arrhythmias. The development of implantable loop recorders (ILR) and continuous glucose monitoring (CGM) enables long-term continuous ECG and glycaemic monitoring. The current article presents the protocol of a study aiming to increase the understanding of arrhythmias and risk factors in patients receiving haemodialysis. The findings will provide a detailed exploration of the burden and nature of arrhythmias in these patients including the potential association between hypoglycaemia and arrhythmias. Methods and analysis The study is an investigator-initiated, prospective, multicentre cohort study recruiting 70 patients receiving haemodialysis: 35 with diabetes and 35 without diabetes. Participants are monitored with ILRs and CGM for 18 months follow-up. Data collection further includes a monthly collection of predialysis blood samples and dialysis parameters. The primary outcome is the presence of clinically significant arrhythmias defined as a composite of bradycardia, ventricular tachycardia, or ventricular fibrillation. Secondary outcomes include the characterisation of clinically significant arrhythmias and other arrhythmias, glycaemic characteristics, and mortality. The data analyses include an assessment of the association between arrhythmias and hypoglycaemia and hyperglycaemia, baseline clinical variables, and parameters related to kidney failure and the haemodialysis procedure. Ethics and dissemination The study has been approved by the Ethics Committee of the Capital Region of Denmark (H-20069767). The findings will be presented at national and international congresses as well as in international peer-reviewed scientific journals. Trial registration number NCT04841304.

Introduction: There is a substantial risk of developing stenosis and dysfunction in the arteriovenous fistula (AVF) in patients on hemodialysis (HD). Far infrared radiation (FIR) is a non-invasive local intervention with a potentially beneficial effect on AVF patency. The underlying mechanism is not clear. It was hypothesized that a single FIR treatment reduces factors of inflammation and promotes endothelial vasodilators in the AVF. Methods: Forty HD patients with an AVF were included in an open-label intervention study. Patients were randomized to receive either FIR (FIR group) or no FIR (control group). Blood samples were drawn directly from the AVF and from a peripheral vein in the non-AVF arm before (T0) and 40 min after (T40) treatment during a HD session. The changes [median (interquartile range)] in circulating factors of inflammation, endothelial function and vasoreactivity during FIR were measured. Results: In the AVF a single FIR treatment during dialysis resulted in a significantly diminished decrease in soluble vascular cell adhesion molecule, sVCAM [-31.6 (-54.3; 22.1) vs -89.9 (-121.6; -29.3), P =. 005] and soluble intercellular adhesion molecule, sICAM [-24.2 (-43.5; 25.3) vs -49 (-79.9; -11.6), P =. 02] compared with the control group. Other factors, such as interleukins, nitrite, nitrate and tumor necrosis factor 1, also declined during dialysis, but with no significant differences related to FIR in either the AVF or the non-AVF arm. Conclusion: A single FIR treatment attenuated the decrease in sVCAM and sICAM in the AVF compared with a control group during HD. Findings do not support the hypothesis of a vaso-protective effect of FIR. The long-term effects of FIR on the AVF are unknown.

Background: The arteriovenous fistula (AVF) is the preferred vascular access for hemodialysis (HD) treatment and preservation of a stable vascular access is crucial. Long term Far Infrared Radiation (FIR) has been found to increase access flow together with an enhanced maturation and patency of the AVF. The acute effects of FIR on access flow have been sparsely described and the results are contradictory, perhaps due to differences in measurement conditions and other factors of importance for access flow. Methods: Twenty patients in HD with an AVF were included. Each patient was randomized to receive either FIR (FIR group) or no FIR (control group). The acute changes in access flow were investigated in both groups on the second dialysis day of the week and during the first 1.5 h of the dialysis session. Concomitant changes in hemodynamic parameters of importance for access flow were also explored. Results: There was no significant change in access flow in the FIR group compared with the control group (median (Interquartile Range)) (−10 (−413.8; 21.3) ml/min vs −17.5 (−83.8; 76.3) ml/min, p = 0.58). There was no significant difference in any of the hemodynamic parameters between the FIR and the control group; cardiac output (−0.7 (−1.2; −0.2) l/min vs −0.4 (−0.9; 0.1) l/min, p = 0.58), cardiac index (−0.3 (−0.5; −0.1)) l/min/m2 vs −0.3 (−0.4; 0) l/min/m2, p = 0.68), mean arterial pressure (5.5 (−1.8; 8.4) mmHg vs 1.5 (−3; 6.3) mmHg, p = 0.35) and total peripheral resistance (2 (1.8; 3.4) mmHg × min/l vs 1 (−0.3; 3.1) mmHg × min/l, p = 0.12). Conclusion: In this trial, with a highly standardized set-up, one session of FIR did not result in any acute changes in access flow. This was not due to differences in the hemodynamic parameters between the groups.

Introduction: The age and number of comorbidities in the hemodialysis population has increased over time. This may influence the construction and survival of the arteriovenous fistula (AVF). The present study explored the incidence and survival of AVFs over a period of 39 years. Methods: A retrospective cohort study was conducted based on Danish registries. Incident hemodialysis patients between 1977 and 2015 were included. The incidence of AVF and factors associated with the construction of an AVF were described. Risk factors for AVF survival and repair were explored by Kaplan Meier and Cox proportional hazard analysis. Results: The total number of arteriovenous accesses (AVF and arteriovenous grafts) were 10,187 and there were 4201 central venous catheters (CVC). No significant difference in the proportion of AVFs during the 39 years was seen. Age and renal diagnosis did not influence the proportion of AVFs. Patients with CVCs were found to have a significantly higher prevalence of comorbidities (p < 0.01). AVF survival remained stable during the 39 years. The first constructed AVF had the best survival, 35% still functioning after 15 years. Factors such as brachiocephalic AVF, female sex, and diabetic nephropathy increased the risk of AVF failure (Odds Ratio (OR): 2.46, 95% Confidence Interval (CI) (2.29–2.65), 1.17 (1.10–1.25), and 1.21 (1.12–1.3)), respectively. Conclusion: Despite an older dialysis population, the proportion and survival of the AVF in the Danish dialysis population has not changed, probably because of increased awareness of AVF as the first choice of vascular access and improved surveillance, surgery, and repair.

Rationale & Objective: Patients with kidney failure need kidney replacement therapy to maximize survival. Kidney transplant is a superior mode of kidney replacement therapy for most individuals with kidney failure. Patients with obesity often are not approved for kidney transplant until they lose sufficient weight, as obesity may complicate the surgical procedure, and the risk of graft loss increases with a higher body mass index. To help potential kidney transplant recipient candidates lose weight, further knowledge of their thoughts, feelings, and attitudes is needed.Study Design: Qualitative study with semi-structured interviews and an exploratory research design, guided by qualitative content analysis.Setting & Participants: Patients at a hospital in Denmark required to lose weight to achieve kidney transplant eligibility.Analytical Approach: From patients' responses, we identified descriptive themes using a phenomenological approach. The factors affecting outcomes were derived reflexively from these themes.Results: Ten interviews were analyzed. Experiences of obesity and weight-loss attempts were described across 4 themes; (1) restrictions and exhaustion, (2) hope and hopelessness, (3) support and self-discipline, and (4) motivation based on severity. A major motivating factor to achieving weight loss in the studied group of patients was their declining kidney function and the fact that kidney transplant cannot be considered until sufficient weight loss is achieved.Limitations: Thematic saturation was reached after an unexpectedly low number of participants. The patients were only interviewed once and over the phone.Conclusions: Patients with obesity who are seeking kidney transplant need additional help with the dietary restrictions brought on by kidney disease. They need assistance bridging between a kidney-friendly diet and a sustainable diet that will ensure weight loss. These patients also express not wa

Arteriovenous fistulas (AVFs) are iatrogenic vascular connections established to allow high-flow intravascular access for patients with chronic kidney disease requiring hemodialysis. The left-right flow shunt results in changes in extracellular fluid volume and blood pressure-controlling hormones that could affect the residual kidney function. We present a case where a female patient with a brachiocephalic AVF had a fistula flow of >4 L/min. To reduce the flow, a banding procedure was performed. The patient was examined prior to banding and 1 and 2 weeks thereafter. Banding resulted in a marked decrease in AVF flow from >4 to 1 L/min and was associated with reductions in N-terminal pro-brain natriuretic peptide of 51% and 67% at 1- and 2-weeks post-banding, respectively. Mid-regional pro-atrial natriuretic peptide concentrations were reduced post-banding by 17% after 1 week and 25% after 2 weeks. After 1 week, renin, angiotensin II, and aldosterone levels in plasma decreased transiently by 44%, 47%, and >86%, respectively, and returned to pre-banding levels after 2 weeks. Creatinine clearance tended to decrease while blood pressure and total body water increased 2 weeks after banding. This indicates that high-flow AVF is associated with increased natriuretic peptides and hormones of the renin–angiotensin–aldosterone system, that may balance each other regarding fluid retention and hypertension and support remaining kidney function.

Background and aims: Plasma apolipoprotein M (APOM) is bound to HDL-particles and has anti-atherogenic effects. The present study explored whether plasma APOM is reduced in patients with chronic kidney disease (CKD), and associated with cardiovascular disease (CVD). In addition, we tested the hypothesis that the excretion of APOM into the urine is increased in patients with kidney disease. Methods: Plasma samples were collected from a cohort of patients with CKD stages 1 to 5D (N = 409) and controls (N = 35). Urine was collected from 47 subjects. Plasma APOM was measured with sandwich ELISA and urine APOM with competitive ELISA. Results: Plasma APOM levels were reduced in patients with CKD stages 3-5D as compared to patients with CKD stages 1 + 2 and controls (p < 0.01). CKD patients with known CVD displayed even further reduction in plasma APOM levels than CKD patients without known CVD (p < 0.001). Fast-phase liquid chromatography showed that plasma APOM was primarily associated with HDL-cholesterol (HDL-C) across CKD stages. Accordingly, when plasma APOM values were corrected for HDL-C, a significant difference only persisted between patients with CKD stage 3 and stages 1 + 2 (p < 0.05), and the difference between CKD patients with and without known CVD disappeared. Urine APOM/creatinine ratio was not significantly increased in patients with kidney disease. Conclusions: The results show that the difference in plasma APOM levels observed between patients with mild and advanced CKD may mainly be due to differences in plasma HDL-C. Whether APOM plays a role in human uremic atherogenesis warrants further experimental studies.

The effects and side effects of medical cannabis are not well-established. In 2018, cannabis was approved as a medical drug in Denmark - giving all doctors the opportunity to subscribe medical cannabis to their patients. In this case report a 64-year-old kidney-transplanted woman started cannabis droplets due to chronic back pain, which resulted in increased appetite, weight gain and development of diabetes mellitus. Patients with an increased risk of developing diabetes may be more prone to this under the treatment with cannabis. Further studies are needed.

Ascites is common in patients with liver cirrhosis. It may present as a clinical manifestation in nephrotic syndrome in adults, typically with heart- or liver disease together with other oedema. We describe a 64-year-old male patient - with no liver or heart disease - with relapsing ascites and no other oedema, who was surprisingly diagnosed with primary membranous nephropathy (MN), and the autoantibody anti-PLA2R was positive. Through immunotherapy the ascites disappeared. Anti-PLA2R and anti-TSHD7A can be used in the diagnosis (primary/secondary MN) and may play a role in the treatment and prognosis.