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Sylvie Brégigeon-Ronot,1 Antoine Cheret,2,3 André Cabié,4 Thierry Prazuck,5 Alain Volny-Anne,6 Shehzad Ali,7 Catherine Bottomley,7 Laurent Finkielsztejn,8 Caroline Philippe,9 Jean-Jacques Parienti10–12 1Clinical Immunohematology Department, Marseille Public University Hospital System (AP-HM), Sainte-Marguerite Hospital, Aix-Marseille University, Marseille, 2Department of Infectious Diseases, Guy-Chatilliez Hospital, Tourcoing, 3Internal Medicine Department, Paris Public University Hospital System (AP-HP), Bicêtre University Hospital Center, EA 7327, University Paris Descartes, Paris, 4Infectious and Tropical Diseases Department, French National Institute of Health and Medical Research (INSERM), CIC 1424, Martinique University Hospital Center, Fort De France, Martinique, 5Infectious Diseases Department, Orleans Regional Hospital Center, Orléans, 6Patient, Paris, France; 7ICON, Contract Research Organization, Patient Reported Outcomes Department, Oxford, United Kingdom; 8ViiV Healthcare, Medical affairs, Marly le Roi, 9Qualees, Contract Research Organization, Epidemilogy Department, Paris, 10Infectious Diseases Department, Caen University Hospital Center, 11Biostatistics and Clinical Research Unit, Caen University Hospital Center, 12EA2656 Microbial Adaptation Research Group (GRAM 2.0), Caen Normandy University, Caen, France Objectives: The objectives were 1) to elicit relative preferences for attributes of antiretroviral therapies (ART) in people living with HIV (PLWH) and 2) to explore satisfaction and adherence with current ART.Patients and methods: We conducted a multicenter cross-sectional study, consecutively enrolling PLWH receiving an ART. The quantitative part estimated the strength of preference for different attributes using an online discrete choice experiment (DCE). DCE data were analyzed using a mixed logit regression model. Qualitative data were collected through individual interviews. A preliminary coding framework was developed which was then further refined and applied during thematic analysis of factors influencing satisfaction and adherence.Results: A total of 101 PLWH took part in the quantitative part and 31 in the qualitative part. Over 90% had an undetectable viral load. Quantitative data revealed a strong preference for a treatment with limited drug–drug interactions, diarrhea and long-term health problems (P

OBJECTIVE: Catheter-associated infections are common, costly, and potentially lethal. The impact of catheter insertion site on infection risk remains controversial. We aimed to establish whether nontunneled central venous catheters inserted in the subclavian vein are associated with lower risk of catheter-associated infection compared to femoral or internal jugular vein insertion. DATA SOURCES: We searched MEDLINE (2000-2011), EMBASE (2000-2011), and Cochrane Library plus meta-analyses, gray literature, reference lists, and articles recommended by experts. STUDY SELECTION AND EXTRACTION: We selected peer-reviewed, randomized, or prospective cohort studies with systematic catheter culture using semiquantitative or quantitative catheter culture techniques and data available for catheter-associated infection by insertion site. Two reviewers independently performed study selection, assessed study quality, and extraction. Discrepancies were resolved by discussion and consensus. Outcomes were mean catheter duration and catheter-associated infection expressed as incidence density per 1000 catheter days. DATA SYNTHESIS: Ten studies (3250 subclavian, 3053 internal jugular, and 1554 femoral vein) met the inclusion criteria, one of which was randomized (136 subclavian vein and 134 femoral vein). Subclavian vein catheters were left in place significantly longer than alternative catheters (mean difference: 2 days, 95% confidence interval [0.9-3.1], I=92%, p<.001). The subclavian vein site was associated with fewer catheter-associated infections (1.3 compared to 2.7 per 1000 catheter days for alternative sites, incidence density ratio 0.50; 95% confidence interval [0.33- 0.74], I=0%, p<.001). The same was true when comparisons were stratified by alternative sites (subclavian vein vs. internal jugular vein, incidence density ratio 0.46; 95% confidence interval [0.30-0.70], I=0%; subclavian vein vs. femoral vein, incidence density ratio 0.27; 95% confidence interval [0.15-0.48], I=31%). CONCLUSION: Shortcomings in study design, including channeling, confounding bias, and study heterogeneity, may limit the interpretation of our preliminary study results. Our analysis suggests that the subclavian site may be associated with a lower risk of catheter-associated infection. However, a large, randomized, controlled trial comparing each catheter site complication is warranted before the subclavian site can be unequivocally recommended as a first choice for central venous catheter insertion. [ABSTRACT FROM AUTHOR]

Context: Based on concerns about the risk of infection, the jugular site is often preferred over the femoral site for short-term dialysis vascular access.Objective: To determine whether jugular catheterization decreases the risk of nosocomial complications compared with femoral catheterization.Design, Setting, and Patients: A concealed, randomized, multicenter, evaluator-blinded, parallel-group trial (the Cathedia Study) of 750 patients from a network of 9 tertiary care university medical centers and 3 general hospitals in France conducted between May 2004 and May 2007. The severely ill, bed-bound adults had a body mass index (BMI) of less than 45 and required a first catheter insertion for renal replacement therapy.Intervention: Patients were randomized to receive jugular or femoral vein catheterization by operators experienced in placement at both sites.Main Outcome Measures: Rates of infectious complications, defined as catheter colonization on removal (primary end point), and catheter-related bloodstream infection.Results: Patient and catheter characteristics, including duration of catheterization, were similar in both groups. More hematomas occurred in the jugular group than in the femoral group (13/366 patients [3.6%] vs 4/370 patients [1.1%], respectively; P = .03). The risk of catheter colonization at removal did not differ significantly between the femoral and jugular groups (incidence of 40.8 vs 35.7 per 1000 catheter-days; hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.62-1.16; P = .31). A prespecified subgroup analysis demonstrated significant qualitative heterogeneity by BMI (P for the interaction term < .001). Jugular catheterization significantly increased incidence of catheter colonization vs femoral catheterization (45.4 vs 23.7 per 1000 catheter-days; HR, 2.10; 95% CI, 1.13-3.91; P = .017) in the lowest tercile (BMI <24.2), whereas jugular catheterization significantly decreased this incidence (24.5 vs 50.9 per 1000 catheter-days; HR, 0.40; 95% CI, 0.23-0.69; P < .001) in the highest tercile (BMI >28.4). The rate of catheter-related bloodstream infection was similar in both groups (2.3 vs 1.5 per 1000 catheter-days, respectively; P = .42).Conclusion: Jugular venous catheterization access does not appear to reduce the risk of infection compared with femoral access, except among adults with a high BMI, and may have a higher risk of hematoma.Trial Registration: clinicaltrials.gov Identifier: NCT00277888. [ABSTRACT FROM AUTHOR]

Background: Anoxic coma following cardiac arrest is a common problem with ethical, social, and legal consequences. Except for unfavorable somatosensory-evoked potentials (SSEP) results, predictors of unfavorable outcome with a 100% specificity and a high sensitivity are lacking. The aim of the current research was to construct a clinical and EEG scoring system that predicts early cortical response (N20) to somatosensory evoked potentials and 6-months outcome in comatose patients after cardiac arrest.Methods: We retrospectively reviewed the records of all consecutive patients who suffered cardiac arrest outside our hospital and were subsequently admitted to our facility from November 2002 to July 2006. We scored each case based on early clinical and EEG factors associated with unfavorable SSEPs, and we assessed the ability of this score to predict SSEP results and outcome.Results: Sixty-six patients qualified for inclusion in the cohort. Among them, 34 (52%) had unfavorable SSEP results. At day three, factors independently associated with unfavorable SSEPs were: absence of corneal (14 points) and pupillary (21 points) reflexes, myoclonus (25 points), extensor or absent motor response to painful stimulation (28 points), and malignant EEG (11 points). A score >40 points had a sensitivity of 85%, a specificity of 84%, and a positive predictive value (PPV) of 85% to predict unfavorable SSEP results. A score >88 points had a PPV of 100%, but a sensitivity of 18%. Overall, this score had an area under ROC curves of 0.919. In addition, at day three, a score > 69 points had a PPV of 100% with a sensitivity of 32% to predict death or vegetative state.Conclusion: A scoring system based on a combination of clinical and EEG findings can predict the absence of early cortical response to SSEPs. In settings without access to SSEPs, this score may help decision-making in a subset of comatose survivors after a cardiac arrest. [ABSTRACT FROM AUTHOR]

Background: Daptomycin stands as a key IV antibiotic in treating MRSA infections. However, patients facing challenges with difficult venous access require alternative administration routes. This study aimed to evaluate the pharmacokinetic (PK) profile and safety of subcutaneous (SC) daptomycin., Patients and Methods: In a two-period, two-treatment, single-blind crossover Phase I trial (ClinicalTrials.gov NCT04434300), participants with no medical history received daptomycin (10 mg/kg) both IV and SC in a random order, with a minimum 2 week washout period together with matched placebo (NaCl 0.9%). Blood samples collected over 24 h facilitated PK comparison. Monte Carlo simulations assessed the PTA for various dosing regimens. Adverse events were graded according to Common Terminology Criteria for Adverse Events(CTCAE) v5.0., Results: Twelve participants (aged 30.9 ± 24.4 years; 9 male,75%) were included. SC daptomycin exhibited delayed (median Tmax 0.5 h for IV versus 4 h for SC) and lower peak concentration than IV (Cmax = 132.2 ± 16.0 μg/mL for IV versus 57.3 ± 8.6 μg/mL for SC; P < 0.001). SC AUC0-24 (937.3 ± 102.5 μg·h/mL) was significantly lower (P = 0.005) than IV AUC0-24 (1056.3 ± 123.5 μg·h/mL) but was deemed bioequivalent. PTA demonstrated target AUC0-24 attainment for 100% of simulated individuals, for both 8 and 10 mg/kg/24 h SC regimens. Adverse events (AEs) related to SC daptomycin were more frequent than for SC placebo (25 versus 13, P = 0.016). No serious AEs were reported., Conclusions: Single-dose SC daptomycin infusion proved to be safe, exhibiting a bioequivalent AUC0-24 compared with the IV route. The SC route emerges as a potential and effective alternative when IV administration is not possible., (© The Author(s) 2024. Published by Oxford University Press on behalf of British Society for Antimicrobial Chemotherapy. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: Borderline Personality Disorder (BPD) is a prevalent and debilitating psychiatric condition often accompanied by Post-Traumatic Stress Disorder (PTSD), with a substantial prevalence of trauma history among affected individuals. The clinical, cognitive, and cerebral parallels shared with PTSD suggest a trauma-related etiology for BPD. Studies consistently demonstrate a reduction in hippocampal volume in individuals with BPD, echoing findings in PTSD. However, the interpretation of this shared neurobiological profile remains contentious, with ongoing debates regarding the independence of these pathologies or the potential exacerbation of diminished hippocampal volume in BPD due to concurrent PTSD. Differential impacts on hippocampal subfields across both disorders may further complicate interpretation, suggesting the volume of hippocampal subfields as a potential discriminant biomarker. This study aims to characterize the multidimensional specific and shared profiles of BPD and PTSD-related alterations, with a particular emphasis on hippocampal subfields during adolescence, a crucial period in BPD development., Methods: This study focuses on female adolescents, who are more prevalent in the BPD population. Participants are categorized into three groups: BPD, BPD with comorbid PTSD, and a control group of matched healthy individuals. Data collection encompasses clinical, cognitive, and neuroimaging domains commonly affected in both disorders, utilizing various imaging markers (including gray matter macrostructure, white matter microstructural integrity, and regional functional connectivity)., Discussion: This study examines adolescent BPD with and without comorbid PTSD on clinical, neuroimaging, and cognitive levels. It is the first to use a comprehensive multi-modal approach within the same sample. Additionally, it uniquely explores hippocampal subfield volume differences in adolescents. Analysis of the relationship between the investigated domains and the effects of PTSD comorbidity will elucidate specific and shared alteration profiles in both disorders., Trial Registration: IDRCB number 2019-A00366-51 / clinicaltrials.gov ID: NCT0485274. Registered on 21/04/2021., (© 2024. The Author(s).)

Introduction: Several randomised controlled trials have demonstrated that novel oral anticoagulants are safer compared with vitamin K antagonists for the management of non-valvular atrial fibrillation (NVAF) to prevent thromboembolic events in the general population. There is a growing interest in the use of apixaban in patients with end-stage renal disease (ESRD) undergoing peritoneal dialysis (PD) but there is a lack of randomised data in this population., Methods and Analysis: APIDP2 is a prospective parallel, randomised, open-label, blinded endpoint trial involving patients with ESRD undergoing chronic PD who have NVAF. A total of 178 participants will be recruited from 20 French PD centres. Eligible patients will be randomly assigned to receive either apixaban at a reduced dose of 2.5 mg two times per day (dose determined with the previous pharmacokinetic study APIDP1) or dose-adjusted to international normalised ratio (INR) target (2-3) coumadin therapy. Anticoagulation to prevent thromboembolic events will be initiated or changed according to the randomisation for a duration of 1 year. The primary outcome is a major or clinically relevant non-major bleeding from randomisation up to month 12, assessed according to the International Society on Thrombosis and Haemostasis Score. Secondary outcomes encompass an efficacy composite criterion combining stroke or transient ischaemic attack (TIA), cardiovascular death and thrombosis including myocardial infarction cumulated at 12 months. Bleeding events will be also classified according to Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) and Thrombolysis In Myocardial Infarction (TIMI) criteria and pharmacodynamics outcomes will evaluate the time within the INR target range of 2-3 in the warfarin arm over 1 year, and anti-Xa apixaban activity in case of bleeding events and at 1 month, 6 months and 12 months of follow-up in the apixaban arm. To demonstrate that apixaban is safer than warfarin at 1 year, assuming two interim analyses after 60 and 118 patients, a bilateral alpha risk of 5% and a power of 80%, 178 patients are needed in this randomised trial (effect size found from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) Study among patients with creatinine clearance 25-30 ml/min), that is, 89 patients per group., Ethics and Dissemination: The study has been approved by the ethics committee Comité de Protection des Personnes Sud Est III - Lyon - FRANCE, CT number 2023-507544-37-00. Written informed consent is required for each participant. Findings will be presented at scientific meetings and published in peer-reviewed journals., Trial Registration: ClinicalTrials.gov, NCT06045858; European Clinical Trial System, CT number 2023-507544-37-00., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Competing Interests: Declaration of competing interest The authors declare no conflict of interest.

Competing Interests: Potential conflicts of interest. The authors: J.-J.P. received honoraria and grants from ViiV, Gilead and Merck outside of this study. Both authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

Purpose: Intraoperative alveolar recruitment maneuvers (ARM) used during protective ventilation strategy may have severe adverse hemodynamic effects, reported mainly during abrupt continuous positive airway pressure (CPAP). Stepwise increase and decrease in positive end expiratory pressure (PEEP) may be used. We compared the hemodynamic effects of these two maneuvers., Methods: We enrolled patients scheduled for intermediate to high-risk surgery with continuous arterial pressure and stroke volume (esophageal Doppler) monitoring in a prospective, single-centre, randomized, double-blind study. After induction of anesthesia, we ensured preload independence of stroke volume before an ARM was randomly performed: 30 cm H 2 O CPAP for 30 sec (CPAP group) or stepwise increase in PEEP from 8 to 20 cm H 2 O with inspiratory pressure of 10 cm H 2 O followed by a stepwise decrease in PEEP from 20 to 8 cm H 2 O (STEP group). The primary outcome was the relative variation in stroke volume., Results: Thirty-five patients were included in the CPAP and STEP groups. Mean (standard deviation) relative variation in stroke volume was -57 (24)% in the CPAP group and -32 (24)% in the STEP group (difference, -25; 95% confidence interval, -37 to -14; P < 0.001). Changes in systolic, mean, and diastolic arterial pressure over time were not different between groups. The ARM was stopped because of a systolic arterial pressure < 70 mm Hg in four patients in the CPAP group and in one patient in the STEP group., Conclusions: Alveolar recruitment maneuvers through stepwise increase and decrease in PEEP have a better hemodynamic tolerance than transient CPAP., Trial Registration: ClinicalTrials.gov (NCT04802421); first submitted 15 March 2021., (© 2023. Canadian Anesthesiologists' Society.)

Introduction: Polypharmacy can lead to drug-drug interactions (DDIs), especially with ART. The burden of co-medications, including over-the-counter (OTC) drugs and self-medications, could be underestimated. We aimed to investigate the proportion of people living with HIV (PLHIV) with declared and undeclared co-medications, as well as their potential burden., Methods: We conducted a national, multicentre, 1 week cross-sectional study between 10 December and 16 December 2019 in 23 French hospitals amongst consecutive adult PLHIV presenting for a routine outpatient visit. A standardized questionnaire filled in by the physicians assessed all medications and other active chemical substances taken by the PLHIV., Results: Overall we enrolled 496 participants from 23 centres. Median age was 50.6 years; ART regimens included an integrase inhibitor in 61% (n = 302), an NNRTI in 34% (n = 169) and a PI in 14% (n = 70) of the cases. Co-medications involved 392 (79%) PLHIV, among which 85 (17%) received polypharmacy (≥5 medications). Previously unknown co-medications or other active substances were found for 32% (n = 159) of the participants. Corticosteroids (9%, n = 46) and proton pump inhibitors (10%, n = 50) were frequently administered. These co-medications did not differ according to age range. Illegal drug use was declared by 11% (n = 54) and OTC drugs by 23% (n = 113) of PLHIV. Potential DDIs were discovered for 11% (n = 53), leading to treatment modifications in 47% (25/53) of cases., Conclusions: Potential DDIs that lead to therapeutic modifications remain significant whatever the age of PLHIV. More devoted time to identify co-medications and OTC treatment is needed in all PLHIV., (© The Author(s) 2023. Published by Oxford University Press on behalf of British Society for Antimicrobial Chemotherapy. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Introduction: To analyze the safety and long-term result of bariatric surgery in patients with psychiatric disorders., Material and Methods: From January 2009 to December 2018, n = 961 patients underwent bariatric surgery in a tertiary center. Among them, two groups of patients were created: a group of patients with psychiatric disorders (PG) and a group without psychiatric disorders (CG), using a propensity score matched (PSM). Primary endpoint was long-term outcomes and secondary endpoints were the postoperative morbidity 90 days after surgery, late morbidity, occurrence of psychiatric adverse events, and resolution of obesity-related comorbidities., Results: Analysis with PSM permitted to compare 136 patients in each group, with a ratio 1:1. TWL% at 2 years in the PG was 32.7% versus 36.6% in the CG (p = 0.002). Overall surgical morbidity was higher in the PG than the CG (28% vs 17%, p = 0.01). Severe surgical complications were not statistically significant (4% vs 3%, p = 0.44). Psychiatric adverse events were significantly more frequent in the PG than in the CG. The resolution of obesity comorbidities was equivalent for both groups at 2 years., Conclusion: Substantial weigh loss was reported among patients with psychiatric disorders receiving bariatric surgery at the cost of more non-severe surgical complications. Further, a psychiatric postoperative follow-up visit may be warranted for patients with preoperative psychiatric disorders, given the incidence of psychiatric adverse events., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: As strength sports gain popularity, there is a growing need to explore the impact of sustained strength training on cardiac biventricular structure and function, an area that has received less attention compared to the well-established physiological cardiac adaptation to endurance training., Objective: This study aims to implement a 20-week high-intensity strength training program to enhance maximal muscle strength and evaluate its impact on cardiac biventricular adaptation in healthy, untrained men., Methods: A total of 27 healthy and untrained young men (mean age 22.8, SD 3.2 years) participated in a strength training program designed to increase muscle strength. The training program involved concentric, eccentric, and isometric exercise phases, conducted over a consecutive 20-week time frame with a frequency of 3 weekly training sessions. Participants were evaluated before and after 12 and 20 weeks of training through body composition analysis (bioelectrical impedance), a 12-lead resting electrocardiogram, 3D transthoracic echocardiography, cardiopulmonary exercise testing, and muscle isokinetic dynamometry. The progression of strength training loads was guided by 1-repetition maximum (RM) testing during the training program., Results: Of the initial cohort, 22 participants completed the study protocol. No injuries were reported. The BMI (mean 69.8, SD 10.8 kg/m² vs mean 72, SD 11 kg/m²; P=.72) and the fat mass (mean 15.3%, SD 7.5% vs mean 16.5%, SD 7%; P=.87) remained unchanged after training. The strength training program led to significant gains in 1-RM exercise testing as early as 4 weeks into training for leg extension (mean 69.6, SD 17.7 kg vs mean 96.5, SD 31 kg; P<.001), leg curl (mean 43.2, SD 9.7 kg vs mean 52.8, SD 13.4 kg; P<.001), inclined press (mean 174.1, SD 41.1 kg vs mean 229.2, SD 50.4 kg; P<.001), butterfly (mean 26.3, SD 6.2 kg vs mean 32.5, SD 6.6 kg; P<.001), and curl biceps on desk (mean 22.9, SD 5.2 kg vs mean 29.6, SD 5.2 kg; P<.001). After 20 weeks, the 1-RM leg curl, bench press, pullover, butterfly, leg extension, curl biceps on desk, and inclined press showed significant mean percentage gains of +40%, +41.1%, +50.3%, +63.5%, +80.1%, +105%, and +106%, respectively (P<.001). Additionally, the isokinetic evaluation confirmed increases in maximal strength for the biceps (+9.2 Nm), triceps (+11.6 Nm), quadriceps (+46.8 Nm), and hamstrings (+25.3 Nm). In this paper, only the training and muscular aspects are presented; the cardiac analysis will be addressed separately., Conclusions: This study demonstrated that a short-term high-intensity strength training program was successful in achieving significant gains in muscle strength among previously untrained young men. We intend to use this protocol to gain a better understanding of the impact of high-intensity strength training on cardiac physiological remodeling, thereby providing new insights into the cardiac global response in strength athletes., Trial Registration: ClinicalTrials.gov NCT04187170; https://clinicaltrials.gov/study/NCT04187170., (©Nicolas Pamart, Joffrey Drigny, Hélène Azambourg, Marion Remilly, Maxime Macquart, Alexandre Lefèvre, Kamal Lahjaily, Jean Jacques Parienti, Amélia Rocamora, Henri Guermont, Antoine Desvergée, Pierre Ollitrault, Francois Tournoux, Eric Saloux, Hervé Normand, Emmanuel Reboursière, Antoine Gauthier, Amir Hodzic. Originally published in JMIR Formative Research (https://formative.jmir.org), 24.10.2023.)

Background: According to European clinical research legislation, no undue influence, including financial incentives, should be used to encourage participation in clinical trials. Financial compensation should be based on the inconvenience experienced by patients and is determined by the sponsor., Objectives: The objective of this study was to assess the adequacy of patients' financial compensation by obtaining an external ethical opinion compared to the actual compensation provided., Methods: We randomly selected and reviewed 50 clinical drug trials, including 25 academic and 25 industry-sponsored studies. An external ethics group consisting of three members from French ethics committees, blinded to the actual compensation and the sponsor, retrospectively reviewed the study characteristics and assessed whether financial compensation was appropriate. Cohen's Kappa test measured agreement between actual compensation and the ethics group's opinion, and the McNemar test measured discrepancies., Results: There was no agreement between the actual financial compensation and the ethics group's opinion (K = -.07; 95% CI = [-.16-.02]). More discrepancies were found in favour of financial compensation according to the ethics group than provided by sponsors (12 vs. 2, p = .016). The ethics group recommended financial compensation in 12 out of 50 studies (24%), which were studies with a higher number of additional visits (p = .004) and were more frequently sponsored by industry (p = .008). Sponsors only provided financial compensation in 2 out of 50 studies (4%)., Conclusion: Patients are rarely compensated despite the perceived inconvenience. Both sponsors and ethics members struggle to determine the need for financial compensation, indicating a need for more precise recommendations for both parties., (© 2023 Stichting European Society for Clinical Investigation Journal Foundation. Published by John Wiley & Sons Ltd.)

Videolaryngoscopy is a suitable alternative to flexible bronchoscopy to facilitate awake tracheal intubation. The relative effectiveness of these techniques in clinical practice is unknown. We compared flexible nasal bronchoscopy with Airtraq ® videolaryngoscopy in patients with an anticipated difficult airway scheduled for awake tracheal intubation. Patients were allocated randomly to flexible nasal bronchoscopy or videolaryngoscopy. All procedures were performed with upper airway regional anaesthesia blockade and a target-controlled intravenous infusion of remifentanil. The success rate with the allocated technique was the primary outcome. A non-inferiority analysis with a predefined limit of 8% was planned. Seventy-eight patients were recruited, allocated randomly and analysed. The rate of successful intubation was 97% and 82% in the flexible bronchoscopy and videolaryngoscopy groups, respectively, p = 0.032. The median (IQR [range]) time to tracheal intubation was shorter with the Airtraq, 163 (105-332 [40-1004]) vs. 217 (180-364 [120-780]) s, p = 0.030. There were no significant differences for complications found between the groups. The median visual analogue scale for ease of intubation was 8 (7-9 [0-10]) for Airtraq vs. 8 (7-9 [0-10]) for flexible bronchoscopy, p = 0.710. The median visual analogue scale for patient comfort for Airtraq was 8 (6-9 [2-10]) vs. 8 (7-9 [3-10]) for flexible bronchoscopy, p = 0.370. The Airtraq videolaryngoscope is not non-inferior to flexible bronchoscopy for awake tracheal intubation in a clinical setting when awake tracheal intubation is indicted. It may be a suitable alternative when judged on a case-by-case basis., (© 2023 Association of Anaesthetists.)

Background: Advances have been made in the use of artificial intelligence (AI) in the field of diagnostic imaging, particularly in the detection of fractures on conventional radiographs. Studies looking at the detection of fractures in the pediatric population are few. The anatomical variations and evolution according to the child's age require specific studies of this population. Failure to diagnose fractures early in children may lead to serious consequences for growth., Objective: To evaluate the performance of an AI algorithm based on deep neural networks toward detecting traumatic appendicular fractures in a pediatric population. To compare sensitivity, specificity, positive predictive value and negative predictive value of different readers and the AI algorithm., Materials and Methods: This retrospective study conducted on 878 patients younger than 18 years of age evaluated conventional radiographs obtained after recent non-life-threatening trauma. All radiographs of the shoulder, arm, elbow, forearm, wrist, hand, leg, knee, ankle and foot were evaluated. The diagnostic performance of a consensus of radiology experts in pediatric imaging (reference standard) was compared with those of pediatric radiologists, emergency physicians, senior residents and junior residents. The predictions made by the AI algorithm and the annotations made by the different physicians were compared., Results: The algorithm predicted 174 fractures out of 182, corresponding to a sensitivity of 95.6%, a specificity of 91.64% and a negative predictive value of 98.76%. The AI predictions were close to that of pediatric radiologists (sensitivity 98.35%) and that of senior residents (95.05%) and were above those of emergency physicians (81.87%) and junior residents (90.1%). The algorithm identified 3 (1.6%) fractures not initially seen by pediatric radiologists., Conclusion: This study suggests that deep learning algorithms can be useful in improving the detection of fractures in children., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: Postoperative morbidity and mortality after cardiac surgery with cardiopulmonary bypass (CPB) remain high despite recent advances in both anesthesia and perioperative management. Among modifiable risk factors for postoperative complications, optimal arterial pressure during and after surgery has been under debate for years. Recent data suggest that optimizing arterial pressure to the baseline of the patient may improve outcomes. We hypothesize that optimizing the mean arterial pressure (MAP) to the baseline MAP of the patient during cardiac surgery with CPB and during the first 24 hours postoperatively may improve outcomes., Study Design: The OPTIPAM trial (NCT05403697) will be a multicenter, randomized, open-label controlled trial testing the superiority of optimized MAP management as compared with a MAP of 65 mm Hg or more during both the intraoperative and postoperative periods in 1,100 patients scheduled for cardiac surgery with CPB. The primary composite end point is the occurrence of acute kidney injury, neurological complications including stroke or postoperative delirium, and death. The secondary end points are hospital and intensive care unit lengths of stay, Day 7 and Day 90 mortality, postoperative cognitive dysfunction on Day 7 and Day 90, and quality of life at Day 7 and Day 90. Two interim analyses will assess the safety of the intervention., Conclusion: The OPTIPAM trial will assess the effectiveness of an individualized target of mean arterial pressure in cardiac surgery with CPB in reducing postoperative morbidity., Clinical Trial Registration: NCT05403697., Competing Interests: Conflict of interest None reported., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Retrospective studies in hematological unit have suggested that single red blood cell (1-RBC) unit transfusion policy may reduce the number of RBC used without negative clinical impact., Method: Acute leukemia patients requiring intensive chemotherapy or patients receiving autologous or allogeneic transplantation were randomly assigned to receive either single RBC (1-RBC arm) or double RBC (2-RBC arm) per transfusion with a hemoglobin trigger of 8 g/dL. The primary composite endpoint was the percentage of patients experiencing serious complications, such as a non-hematological adverse event grade ≥ 3 or intensive care admission or death., Findings: A total of 981 and 592 RBC transfusions were required in the 1-RBC arm (n = 125) and the 2-RBC arm (n = 120), respectively. The mean pre-transfusion hemoglobin levels were 7.49 ± 0.83 g/dL in the 1-RBC arm and 7.46 ± 0.67 g/dL in the 2-RBC arm (p = 0.275). The predefined non-inferiority criteria was achieved with 28/125 patients reaching the primary endpoint in the 1-RBC arm (22.4 %) and 28/120 patients in the 2-RBC arm (23.3 %) (Risk difference 0.009; 95 %, Confidence interval [-0.0791 to 0.0978], p = 0.021). The median (IQR) of RBC units transfused per patient was 7 (4-12) in the 1-RBC arm and 8 (4-12) in 2-RBC arm. Hemoglobin levels at discharge were also comparable in both arms., Interpretation: The results of this trial indicate that a single RBC transfusion policy is not inferior to a double RBC transfusion policy for patients receiving a bone marrow transplant or intensive chemotherapy in a hematological intensive care unit. However, the single RBC transfusion policy did not reduce the number of RBC units transfused per stay., Funding: This trial was funded by a grant from the French Ministry of Health., Competing Interests: Conflict of interest No conflict of interest were reported by authors., (Copyright © 2023. Published by Elsevier Ltd.)

Background: Postoperative atrial fibrillation (PoAF) after cardiac surgery has a high incidence of 30%, but its management is controversial. Two strategies are recommended without evidence of a superiority of one against the other: rate control with beta-blocker or rhythm control with amiodarone. Landiolol is a new-generation beta-blocker with fast onset and short half-life. One retrospective, single-center study compared landiolol to amiodarone for PoAF after cardiac surgery with a better hemodynamic stability and a higher rate of reduction to sinus rhythm with landiolol, justifying the need for a multicenter randomized controlled trial. Our aim is to compare landiolol to amiodarone in the setting of PoAF after cardiac surgery with the hypothesis of a higher rate of reduction to sinus rhythm with landiolol during the 48 h after the first episode of POAF., Methods: The FAAC trial is a multicenter single-blind two parallel-arm randomized study, which planned to include 350 patients with a first episode of PoAF following cardiac surgery. The duration of the study is 2 years. The patients are randomized in two arms: a landiolol group and an amiodarone group. Randomization (Ennov Clinical®) is performed by the anesthesiologist in charge of the patient if PoAF is persistent for at least 30 min after correction of hypovolemia, dyskalemia, and absence of pericardial effusion on a transthoracic echocardiography done at bedside. Our hypothesis is an increase of the percentage of patients in sinus rhythm from 70 to 85% with landiolol in less than 48 h after onset of PoAF (alpha risk = 5%, power = 90%, bilateral test)., Discussion: The FAAC trial was approved by the Ethics Committee of EST III with approval number 19.05.08. The FAAC trial is the first randomized controlled trial comparing landiolol to amiodarone for PoAF after cardiac surgery. In case of higher rate of reduction with landiolol, this beta-blocker could be the drug of choice used in this context as to reduce the need for anticoagulant therapy and reduce the risk of complications of anticoagulant therapy for patients with a first episode of postoperative atrial fibrillation after cardiac surgery., Trial Registration: ClinicalTrials.gov NCT04223739. Registered on January 10, 2020., (© 2023. The Author(s).)

Introduction: Natalizumab, a therapy for relapsing-remitting multiple sclerosis (RRMS), is associated with a risk of progressive multifocal leukoencephalopathy (PML). Over the last several years, practitioners have used off-label extended interval dosing (EID) of natalizumab to reduce PML risk, despite the absence of a large-scale efficacy evaluation., Methods: We conducted a retrospective, multicenter cohort study among adults with RRMS receiving stable standard interval dosing (SID), defined as a ≥ 12-month consecutive period of ≥ 11 natalizumab infusions/year in France. We compared the 12-month risk difference of remaining relapse-free (primary endpoint) between patients who switched to EID (≤ 9 natalizumab infusions) and those who remained on SID, with a noninferiority margin of - 11%. We used propensity score methods such as inverse probability treatment weighting (IPTW) and 1:1 propensity score matching (PSM). Secondary endpoints were annualized relapse rate, disease progression, and safety., Results: Baseline characteristics were similar between patients receiving EID (n = 147) and SID (n = 156). The proportion of relapse-free patients 12 months postbaseline was 142/147 in the EID (96.6%) and 144/156 in the SID group (92.3%); risk difference (95% CI) 4.3% (- 1.3 to 9.8%); p < 0.001 for non-inferiority. There were no significant differences between relapse rates (0.043 vs. 0.083 per year, respectively; p = 0.14) or Expanded Disability Status Scale mean scores (2.43 vs. 2.72, respectively; p = 0.18); anti-JC virus index values were similar (p = 0.23); and no instances of PML were reported. The comparisons using IPTW (n = 306) and PSM (n = 204) were consistent., Conclusion: These results support the pertinence of using an EID strategy for RRMS patients treated with natalizumab., Clinical Trials: gov identifier (NCT04580381)., (© 2023. The Author(s).)

The clinical presentation of chronic myeloid leukemia (CML) at diagnosis differs in children compared to adults. At younger age, anemia appears to be frequent at diagnosis, but its prevalence and its impact on prognosis are not well known. In the International Registry of Childhood CML, we selected children and adolescents in chronic phase at diagnosis of CML and treated upfront with imatinib. We examined their hemoglobin level at diagnosis according to the WHO grades to assess the prevalence of anemia and its impact on response to tyrosine kinase inhibitors (TKIs). Data on 430 patients were included. Anemia at diagnosis was observed in 350 patients (81%), with a mean hemoglobin level of 96.4 g/l (SD 23.6). Among them, 182 patients (52%) presented with moderate anemia and 110 (31%) with severe anemia while 58 (17%) had mild anemia. Compared with mild and no anemia, moderate and severe forms were significantly associated with younger age at diagnosis, asthenia, splenomegaly, and increased leukocyte and basophil counts. Delays in achieving major and deep molecular responses were significantly increased for patients with moderate and severe anemia, and also failure of imatinib treatment was more frequent in these two sub-cohorts. However, hemoglobin level was not significantly associated with survival. Anemia at diagnosis of pediatric CML was frequent and may be considered as a prognostic factor., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: The anatomic site for central venous catheter insertion influences the risk of central venous catheter-related intravascular complications. We developed and validated a predictive score of required catheter dwell time to identify critically ill patients at higher risk of intravascular complications., Methods: We retrospectively conducted a cohort study from three multicenter randomized controlled trials enrolling consecutive patients requiring central venous catheterization. The primary outcome was the required catheter dwell time, defined as the period between the first catheter insertion and removal of the last catheter for absence of utility. Predictors were identified in the training cohort (3SITES trial; 2336 patients) through multivariable analyses based on the subdistribution hazard function accounting for death as a competing event. Internal validation was performed in the training cohort by 500 bootstraps to derive the CVC-IN score from robust risk factors. External validation of the CVC-IN score were performed in the testing cohort (CLEAN, and DRESSING2; 2371 patients)., Results: The analysis was restricted to patients requiring mechanical ventilation to comply with model assumptions. Immunosuppression (2 points), high creatinine > 100 micromol/L (2 points), use of vasopressor (1 point), obesity (1 point) and older age (40-59, 1 point; ≥ 60, 2 points) were independently associated with the required catheter dwell time. At day 28, area under the ROC curve for the CVC-IN score was 0.69, 95% confidence interval (CI) [0.66-0.72] in the training cohort and 0.64, 95% CI [0.61-0.66] in the testing cohort. Patients with a CVC-IN score ≥ 4 in the overall cohort had a median required catheter dwell time of 24 days (versus 11 days for CVC-IN score < 4 points). The positive predictive value of a CVC-IN score ≥ 4 was 76.9% for > 7 days required catheter dwell time in the testing cohort., Conclusion: The CVC-IN score, which can be used for the first catheter, had a modest ability to discriminate required catheter dwell time. Nevertheless, preference of the subclavian site may contribute to limit the risk of intravascular complications, in particular among ventilated patients with high CVC-IN score. Trials Registration NCT01479153, NCT01629550, NCT01189682., (© 2023. The Author(s).)

Background: The link between immediate hypersensitivity reactions (HSR) following the first cetuximab infusion and the IgE sensitization against anti-galactose-α-1,3-galactose (α-Gal) is now well-established. An automated Fluoroenzyme-Immunoassay (FEIA) is available and may facilitate the screening of patients with anti-α-Gal IgE before treatment., Methods: This study aimed to evaluate its performances as compared to a previously validated anti-cetuximab IgE ELISA, using 185 samples from two previously studied cohorts., Results: Despite 21.1% of discrepancies between the two techniques, FEIA discriminated better positive patients and similarly negative ones with a ≥ 0.525 kU A /L threshold. Sensitivity was 87.5% for both tests, specificity was better for FEIA (96.3% vs ELISA: 82.1%). FEIA had a higher positive likelihood ratio (23.9 vs ELISA: 4.89) and a similar negative likelihood ratio (0.13 vs ELISA: 0.15). In our population, the risk of severe HSR following a positive test was higher with FEIA (56.7% vs ELISA: 19.6%) and similar following a negative test (0.7% vs ELISA: 0.8%)., Conclusion: Although the predictive value of the IgE screening before cetuximab infusion remains discussed, this automated commercial test can identify high-risk patients and is suitable for routine use in laboratories. It could help avoiding cetuximab-induced HSR by a systematic anti-α-Gal IgE screening before treatment., (© 2023. The Author(s).)

Background: Crushing or dissolving bictegravir/tenofovir alafenamide/emtricitabine (BIC/TAF/FTC) tablets is not recommended because there are no data supporting this practice., Methods: A crossover, randomized trial in healthy adults (NCT04244448) investigated the bioavailability of two off-label uses of BIC/TAF/FTC (50/200/25 mg), dissolved in water or crushed in apple compote, compared with the solid tablet. Pharmacokinetic (PK) parameters were estimated from sequential intensive plasma antiretroviral concentrations over a 72 h period post dose. Bioequivalence was met if the 90% CIs of the geometric least-squares means ratios comparing BIC/TAF/FTC exposures (AUC and Cmax) from the experimental phases were within 80%-125% of the reference., Results: Eighteen subjects participated in each of the three phases. Dissolved tablet Cmax geometric mean ratio (90% CI) for BIC/TAF/FTC was 105% (93-119)/97% (87-108)/96% (74-124), respectively. Dissolved tablet AUC geometric mean ratio (90% CI) for BIC/TAF/FTC was 111% (100-122)/100% (94 to 105)/99% (81 to 120), respectively. Crushed tablet Cmax geometric mean ratio (90%) CI for BIC/TAF/FTC was 110% (97 to 124)/70% (63-78)/66% (51-85), respectively. Crushed tablet AUC geometric mean ratio (90%) CI for BIC/TAF/FTC was 107% (96-118)/86% (82-91)/84% (69-103), respectively., Conclusions: Crushing BIC/TAF/FTC tablets may lead to suboptimal emtricitabine and tenofovir alafenamide drug exposures. Dissolving BIC/TAF/FTC in water may be acceptable if the tablet cannot be swallowed whole., (© The Author(s) 2022. Published by Oxford University Press on behalf of British Society for Antimicrobial Chemotherapy.)

Purpose: Intravenous maintenance fluid therapy (IV-MFT) prescribing in acute and critically ill children is very variable among pediatric health care professionals. In order to provide up to date IV-MFT guidelines, the European Society of Pediatric and Neonatal Intensive Care (ESPNIC) undertook a systematic review to answer the following five main questions about IV-MFT: (i) the indications for use (ii) the role of isotonic fluid (iii) the role of balanced solutions (iv) IV fluid composition (calcium, magnesium, potassium, glucose and micronutrients) and v) and the optimal amount of fluid., Methods: A multidisciplinary expert group within ESPNIC conducted this systematic review using the Scottish Intercollegiate Guidelines Network (SIGN) grading method. Five databases were searched for studies that answered these questions, in acute and critically children (from 37 weeks gestational age to 18 years), published until November 2020. The quality of evidence and risk of bias were assessed, and meta-analyses were undertaken when appropriate. A series of recommendations was derived and voted on by the expert group to achieve consensus through two voting rounds., Results: 56 papers met the inclusion criteria, and 16 recommendations were produced. Outcome reporting was inconsistent among studies. Recommendations generated were based on a heterogeneous level of evidence, but consensus within the expert group was high. "Strong consensus" was reached for 11/16 (69%) and "consensus" for 5/16 (31%) of the recommendations., Conclusions: Key recommendations are to use isotonic balanced solutions providing glucose to restrict IV-MFT infusion volumes in most hospitalized children and to regularly monitor plasma electrolyte levels, serum glucose and fluid balance., (© 2022. The Author(s).)

Objectives: We aimed to evaluate the association between proton pump inhibitor (PPI) exposure and nosocomial infection (NI) during PICU stay., Design: Propensity score matched analysis of a single-center retrospective cohort from January 1, 2017, to December 31, 2018., Setting: Tertiary medical and surgical PICU in France., Patients: Patients younger than 18 years old, admitted to the PICU with a stay greater than 48 hours., Intervention: Patients were retrospectively allocated into two groups and compared depending on whether they received a PPI or not., Measurements and Main Results: Seven-hundred fifty-four patients were included of which 231 received a PPI (31%). PPIs were mostly used for stress ulcer prophylaxis (174/231; 75%), but upper gastrointestinal bleed risk factors were rarely present (18%). In the unadjusted analyses, the rate of NI was 8% in the PPI exposed group versus 2% in the nonexposed group. After propensity score matching ( n = 184 per group), we failed to identify an association between PPI exposure and greater odds of NI (adjusted odds ratio 2.9 [95% CI, 0.9-9.3]; p = 0.082). However, these data have not excluded the possibility that there is up to nine-fold greater odds of NI., Conclusions: This study highlights the prevalent use of PPIs in the PICU, and the potential association between PPIs and nine-fold greater odds of NI is not excluded., Competing Interests: Dr. Goyer received funding from Braun Medical. Dr. Dupont received funding from Abbvie. The remaining authors have disclosed that they do not have any potential conflicts of interest., (Copyright © 2022 by the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies.)

Cytochrome P450 2D6 (CYP2D6) gene polymorphisms influence the exposure to tramadol (T) and its pharmacologically active metabolite, O-demethyl tramadol (O-dT). Tramadol has been considered as a candidate probe drug for CYP2D6 phenotyping. The objective of the CYTRAM study was to investigate the value of plasma O-dT/T ratio for CYP2D6 phenotyping. European adult patients who received IV tramadol after surgery were included. CYP2D6 genotyping was performed and subjects were classified as extensive (EM), intermediate (IM), poor (PM), or ultra-rapid (UM) CYP2D6 metabolizers. Plasma concentrations of tramadol and O-dT were determined at 24 h and 48 h. The relationship between O-dT/T ratio and CYP2D6 phenotype was examined in both a learning and a validation group. Genotype data were obtained in 301 patients, including 23 PM (8%), 117 IM (39%), 154 EM (51%), and 7 UM (2%). Tramadol trough concentrations at 24 h were available in 297 patients. Mean value of O-dT/T ratio was significantly lower in PM than in non-PM individuals (0.061 ± 0.031 versus 0.178 ± 0.09, p < 0.01). However, large overlap was observed in the distributions of O-dT/T ratio between groups. Statistical models based on O-dT/T ratio failed to identify CYP2D6 phenotype with acceptable sensitivity and specificity. Those results suggest that tramadol is not an adequate probe drug for CYP2D6 phenotyping.

Introduction: The use of predictive low-glucose suspend (PLGS) sensor-augmented pumps has been shown to lead to a significant reduction in hypoglycemic episodes in patients with type 1 diabetes (T1D), but their effects on hyperglycemia exposure are heterogeneous. The aim of this study was to determine the settings of the Medtronic 640G system to obtain the optimal balance between occurrence of both hypoglycemia and hyperglycemia., Methods: The hypo- and hyperglycemia area under the curve (AUC), as well as system settings [hypoglycemic threshold, mean insulin total daily dose (TDD), mean basal insulin percentage, and mean daily duration of PLGS] were collected between 2 and 12 times during 1 year in patients from four university hospital centers. Univariate/multivariate analyses and receiver operating characteristics (ROC) curves were performed to determine factors associated with hyper- and hypoglycemia AUC., Results: A total of 864 observations were analyzed from 110 patients with T1D. Two preselected settings predictive of low hyperglycemia AUC were a basal insulin percentage < 52.0% [sensitivity (Se) = 0.66 and specificity (Sp) = 0.53] and a PLGS duration > 157.5 min/day (Se = 0.47 and Sp = 0.73). The preselected setting predictive of a low hypoglycemia AUC was a PLGS duration ≤ 174.4 min (Se = 0.83 and Sp = 0.51). Between-visit variation of PLGS and TDD was positively correlated (r = 0.61; p < 0.0001)., Conclusion: The most important Medtronic 640G setting was the mean daily PLGS duration, where a value between 157.5 and 174.4 min/day was associated with the best reduction in both hypo- and hyperglycemia AUC. In this study, we showed that PLGS duration could be indirectly modified through total daily insulin dose adaptation., Trial Registration: This study is registered in clinicaltrials.gov (NCT03047486)., (© 2022. The Author(s).)

Objective: Postoperative pulmonary complications (PPC) remain a main issue after cardiac surgery. The objective was to report the incidence and identify risk factors of PPC after cardiac surgery., Design: An international multicenter prospective study (42 international centers in 9 countries)., Participants: A total of 707 adult patients who underwent cardiac surgery under cardiopulmonary bypass., Interventions: None MEASUREMENTS AND MAIN RESULTS: During a study period of 2 weeks, the investigators included all patients in their respective centers and screened for PPCs. PPC was defined as the occurrence of at least 1 pulmonary complication among the following: atelectasis, pleural effusion, respiratory failure, respiratory infection, pneumothorax, bronchospasm, or aspiration pneumonitis. Among 676 analyzed patients, 373 patients presented with a PPC (55%). The presence of PPC was significantly associated with a longer intensive care length of stay and hospital length of stay. One hundred ninety (64%) patients were not intraoperatively ventilated during cardiopulmonary bypass. Ventilation settings were similar regarding tidal volume, respiratory rate, inspired oxygen. In the regression model, age, the Euroscore II, chronic obstructive pulmonary disease, preoxygenation modality, intraoperative positive end-expiratory pressure, the absence of pre- cardiopulmonary bypass ventilation, the absence of lung recruitment, and the neuromuscular blockade were associated with PPC occurrence., Conclusion: Both individual risk factors and ventilatory settings were shown to explain the high level of PPCs. These findings require further investigations to assess a bundle strategy for optimal ventilation strategy to decrease PPC incidence., Competing Interests: Conflict of Interest None., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Poor securement potentiates Peripherally inserted central catheters (PICC) complications. A dressing device (KT FIX Plus) offers stronger skin attachment, which may reduce the risk of dressing disruption. We aimed to evaluate this device., Methods: We conducted a single-center parallel-group open-label randomized controlled trial. Hospitalized and outpatient consecutive adults requiring PICCs were randomized to KT FIX Plus or standard of care (SOC). The primary endpoint was the composite of PICC-associated complications until removal, including occlusion, migration, accidental withdrawal, infection, thrombosis, and hematoma., Results: No statistically significant difference was observed in terms of complications: 67 (35%) in the KT FIX Plus group vs 36 (37%) in the SOC group (log-rank P = 0.76). In multivariate Cox analysis, independent risk factors for PICC-associated complications were obesity (adjusted hazard ratio (aHR), 1.08, P < .001) and diabetes (aHR, 1.85, P = .039), adjusting for chronic renal failure, number of lumens, catheter/vein diameter ratio and duration of home-based care. Multiple lumen catheters increased the risk of accidental withdrawal and migration (HR, 2.4, P = .008)., Conclusions: In our study, the use of KT FIX Plus did not reduce the risk of complications adjusting for other risk factors such as obesity and diabetes. The number of catheter lumens is one of the modifiable factors to reduce complications. Further studies are required to find the best securement and dressing system., (Copyright © 2022 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.)