Compensating patients in trials: Perspectives from an ethical committee versus sponsor.

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.

A New Procedure for Guidewire Exchange of Tunneled Hemodialysis Catheters in Chronic Hemodialysis Patients: A Pilot Study.

INTRODUCTION: Different techniques of guidewire exchange of tunneled catheters for hemodialysis (HD) have been reported. This study was carried out to assess the feasibility of a new procedure in chronic HD patients who needed catheter exchange because of mechanical dysfunction. METHODS: The guidewire exchange method was based on the creation of a new exit site and a new subcutaneous tunnel while using the same venous insertion site. This was a retrospective study of exchanged tunneled catheters because of mechanical complications in patients on chronic HD between June 1, 2015, and December 31, 2019. The feasibility of the procedure was defined by successful exchange and catheter patency at 6 months. Catheter survival and immediate complications were reported. RESULTS: A total of 49 procedures were performed in 34 HD patients. There was no catheter insertion failure. At 6 months, 6 catheters have lost their patency because of a mechanical complication. Thus, the success rate of the procedure was 43/49 (87.8%). Catheter survival censored on death, transplantation, or vascular access creation was 97.8% at 90 days, 86.2% at 180 days, and 74.5% at 1 year. The median catheter survival was 10.2 months. Among the 49 procedures, there were 9 hematomas at the insertion site that did not require surgical intervention. Discussion/Conlusion: Our study shows that guidewire exchange of a tunneled HD catheter by creating a new exit site and a new subcutaneous tunnel by using the same venous access is a newer method in chronic HD patients. This procedure should not be used in patients with coagulation issues. Additional studies are needed to compare the different methods of HD catheter exchange.

What Total Body Water Measurement Should Be Used for Prescribing the Dialysis Dose in Low-Flow Home Daily Dialysis?

INTRODUCTION: In low-flow home daily dialysis (HDD), the dialysis dose is evaluated from the total body water (TBW). TBW can be estimated by anthropometric methods or bioimpedance spectroscopy. METHODS: A multicentric cross-sectional study of patients in HDD for >3 months was conducted to assess the correlation and the difference between the anthropometric estimate of TBW (Watson-TBW) and the bioimpedance estimate (BIS-TBW) and to analyse the impact on the dialysate volume prescribed. RESULTS: Forty patients from 10 centres were included. The median BIS-TBW and Watson-TBW were 35.1 (29.1-41.4 L) and 36.9 (32-42.4 L), respectively. The 2 methods had a good correlation (r = 0.87, p < 0.05). However, Bland-Altman analysis showed an overestimation of TBW with Watson's formula, with a bias of 2.77 L. For 4, 5, or 6 sessions per week, the use of Watson-TBW increases the dialysate prescription per week by 100 L, 45 L, or 10 L, respectively, over our entire cohort. There is no increase in the volume of dialysate prescribed with the 7 sessions per week schedule. CONCLUSION: BIS-TBW and Watson-TBW estimation have a good correlation; however, Watson's equation overestimates TBW. This overestimation is negligible for a prescription frequency of >5 sessions per week.

Assisted peritoneal dialysis and transfer to haemodialysis: a cause-specific analysis with data from the RDPLF.

BACKGROUND: Technique failure, defined as death or transfer to haemodialysis (HD), is a major concern in peritoneal dialysis (PD). Nurse-assisted PD is globally associated with a lower risk of transfer to HD. We aimed to evaluate the association between assisted PD and the risk of the different causes of transfer to HD. METHODS: This was a retrospective study using data from the French Language PD Registry of patients on incident PD from 2006 to 2015. The association between the use of assisted PD and the causes of transfer to HD was evaluated using survival analysis with competing events in unmatched and propensity score-matched cohorts. RESULTS: The study included 11 093 incident PD patients treated in 123 French PD units. There were 4273 deaths, 3330 transfers to HD and 2210 renal transplantations. The causes of transfer to HD were inadequate dialysis (1283), infection (524), catheter-related problems (334), social issues (250), other causes linked to PD (422), other causes not linked to PD (481) and encapsulating peritoneal sclerosis (6). Nurse-assisted PD patients were older and more comorbid. Assistance by nurse was associated with a higher risk of death [cause-specific hazard ratio (cs-HR) 2.49, 95% confidence interval (CI) 2.26-2.74], but with a lower risk of transfer to HD [subdistributionHR (sd-HR) 0.68, 95% CI 0.62-0.76], especially due to inadequate dialysis (cs-HR 0.83, 95% CI 0.75-0). CONCLUSIONS: The lower risk of transfer to HD associated with nurse assistance should encourage decision makers to launch reimbursement programmes in countries where it is not available.

Using more frequent haemodialysis to manage volume overload in dialysis patients with heart failure, obesity or pregnancy.

Managing dialysis in patients with heart failure, pregnancy or obesity is complex. More frequent haemodialysis 5-6 days/week in randomized clinical trials has shown benefits for controlling volume overload, blood pressure and phosphorus, reducing left ventricular hypertrophy (LVH), and improving patient tolerance to therapy. Therapy prescriptions were guided by volume of urea cleared, time-integrated fluid loading control and increased phosphate-ß2 microglobulin removal, with greater treatment frequency to address clinical efficacy targets. Case studies in all three categories show that treatment with more frequent haemodialysis in low-dialysate flow systems (Qd <200 mL/min, dialysate of 25-30 L/session, 5-7 days/week for 2.5-3.0 h/session) improves control of heart failure. In pregnancy, treatment 7 days/week with 30 L and 3 h/session of dialysis enabled successful delivery of infants at 32-34 weeks, with all doing well 2-5 years after birth. Obese patients with a body mass index (BMI) >35 achieved control of volume, blood pressure and uraemic symptoms compared to their prior 3 times/week in-centre haemodialysis. Greater application of more frequent haemodialysis should be considered, particularly in high-risk populations, to improve clinical care.

Is self-care dialysis associated with social deprivation in a universal health care system? A cohort study with data from the Renal Epidemiology and Information Network Registry.

BACKGROUND: Socioeconomic status is associated with dialysis modality in developed countries. The main objective of this study was to investigate whether social deprivation, estimated by the European Deprivation Index (EDI), was associated with self-care dialysis in France. METHODS: The EDI was calculated for patients who started dialysis in 2017. The event of interest was self-care dialysis 3 months after dialysis initiation [self-care peritoneal dialysis (PD) or satellite haemodialysis (HD)]. A logistic model was used for the statistical analysis, and a counterfactual approach was used for the causal mediation analysis. RESULTS: Among the 9588 patients included, 2894 (30%) were in the most deprived quintile of the EDI. A total of 1402 patients were treated with self-care dialysis. In the multivariable analysis with the EDI in quintiles, there was no association between social deprivation and self-care dialysis. Compared with the other EDI quintiles, patients from Quintile 5 (most deprived quintile) were less likely to be on self-care dialysis (odds ratio 0.81, 95% confidence interval 0.71-0.93). Age, sex, emergency start, cardiovascular disease, chronic respiratory disease, cancer, severe disability, serum albumin and registration on the waiting list were associated with self-care dialysis. The EDI was not associated with self-care dialysis in either the HD or in the PD subgroups. CONCLUSIONS: In France, social deprivation estimated by the EDI is associated with self-care dialysis in end-stage renal disease patients undergoing replacement therapy.

Effects of educational practices on the peritonitis risk in peritoneal dialysis: a retrospective cohort study with data from the French peritoneal Dialysis registry (RDPLF).

BACKGROUND: Peritoneal dialysis (PD) is a home-based therapy performed by patients or their relatives in numerous cases, and the role of patients' educational practices in the risk of peritonitis is not well assessed. Our aim was to evaluate the effect of PD learning methods on the risk of peritonitis. METHODS: This was a retrospective multicentric study based on data from a French registry. All incident adults assisted by family or autonomous for PD exchanges in France between 2012 and 2015 were included. The event of interest was the occurrence of peritonitis. Cox and hurdle regression models were used for statistical analysis to asses for the survival free of peritonitis, and the risk of first and subsequent peritonitis. RESULTS: 1035 patients were included. 967 (93%) received education from a specialized nurse. Written support was used for the PD learning in 907 (87%) patients, audio support in 221 (21%) patients, and an evaluation grid was used to assess the comprehension in 625 (60%) patients. In the "zero" part of the hurdle model, the use of a written support and starting PD learning with hands-on training alone were associated with a lower survival free of peritonitis (respectively HR 1.59, 95%CI 1.01-2.5 and HR 1.94, 95%CI 1.08-3.49), whereas in the "count" part, the use of an audio support and starting of PD learning with hands-on training in combination with theory were associated with a lower risk of presenting further episodes of peritonitis after a first episode (respectively HR 0.55, 95%CI 0.31-0.98 and HR 0.57, 95%CI 0.33-0.96). CONCLUSIONS: The various PD education modalities were associated with differences in the risk of peritonitis. Prospective randomized trials are necessary to confirm causal effect. Caregivers should assess the patient's preferred learning style and their literacy level and adjust the PD learning method to each individual.

Assessment for Assisted Peritoneal Dialysis by Peritoneal Dialysis Nurses: Results of a Cohort Study.

BACKGROUND: Selection of patients for assisted peritoneal dialysis (PD) is based on the nurse's assessment of the patient. There is no data available about the nurse's assessment of the PD patient at the initiation of PD to estimate the need for assisted PD at the national level. This study was carried out to evaluate the association between the nurse's subjective assessment of the patient's inability to be treated by self-care PD, the nurse evaluation of the patient disabilities and the utilization of nurse or family assisted PD. METHODS: This was a retrospective study of patients starting PD between July 1, 2010 and 2015 and registered in the nurse section of the French Language PD Registry (RDPLF). Poisson regression and a linear regression model with a robust variance estimator were used for the statistical analysis to determine relative risks (RRs) and risk differences (RDs). RESULTS: Of 4,101 PD patients, 403 were treated by family assisted PD, and 1,695 were treated by nurse-assisted PD. In the multivariate analysis, the nurse's subjective assessment of the patient's inability to be treated by self-care PD was associated with nurse-assisted PD (5.40 [4.58-6.35], 67% [64-70%]) and family assisted PD (11.11 [8.49-14.56], RD 62% [57-67%]). Nurse-assisted PD and family assisted PD were associated with functional impairment (RR 1.25 [95% CI 1.16-1.36], RD 14% [95% CI 10-19%] and RR 2.02 [95% CI 1.69-2.41], RD 27% [95% CI 20-34%] respectively), cognitive dysfunction (RR 1.23 [95% CI 1.15-1.32], RD 15% [95% CI 11-18%] and RR 1.73 [95% CI 1.39-2.16], RD 12% [95% CI 7-18%] respectively) and deafness (RR 1.10 [95% CI 1.04-1.16], RD 8% [95% CI 5-11%] and RR 1.46 [95% CI 1.22-1.74], RD 10% [95% CI 6-14%] respectively). CONCLUSION: Our results showed that the nurse's subjective assessment of the patient's inability to be treated by self-care PD and the patient's disabilities were strongly associated with the utilization of nurse- and family assisted PD.

Impact of Assisted Peritoneal Dialysis Modality on Outcomes: A Cohort Study of the French Language Peritoneal Dialysis Registry.

BACKGROUND: Patients on peritoneal dialysis (PD) can be assisted by a nurse or a family member and treated either by automated PD (APD) or continuous ambulatory PD (CAPD). The aim of this study was to evaluate the effect of PD modality and type of assistance on the risk of transfer to haemodialysis (HD) and on the peritonitis risk in assisted PD patients. METHOD: This was a retrospective study based on data from the French Language PD Registry. All adults starting assisted PD in France between 2006 and 2015 were included. Events of interest were transfer to HD, peritonitis and death. Cox regression models were used for statistical analysis. RESULTS: Among the 12,144 incident patients who started PD in France during the study period, 6,167 were assisted. There were 5,060 nurse-assisted and 1,095 family-assisted PD patients. Overall, 5,171 were treated by CAPD and 996 by APD. In multivariate analysis, CAPD, compared to APD, was not associated with the risk of transfer to HD (cause specific hazard ratios [cs-HR] 0.96 [95% CI 0.84-1.09]). Patients on nurse-assisted PD had a lower risk of transfer to HD than family assisted PD patients (cs-HR 0.85 [95% CI 0.75-0.97]). Neither PD modality nor type of assistance were associated with peritonitis risk. CONCLUSIONS: In assisted PD, technique survival was not associated with PD modality. Nurse-assisted patients had a lower risk of transfer to HD than family assisted patients. Peritonitis risk was not influenced either by PD modality, or by type of assistance. Both APD and CAPD should be offered to assisted-PD patients.

Factors associated with nurse assistance among peritoneal dialysis patients: a cohort study from the French Language Peritoneal Dialysis Registry.

Background: No information is available regarding nurse-assisted peritoneal dialysis (PD) in non-elderly subjects. This study was carried out to estimate the rate of nurse-assisted PD among non-elderly patients and to assess which individual and centre factors were associated with nurse-assisted PD. The other objective was to estimate the magnitude of the centre effect on the utilization of nurse-assisted PD using hierarchical modelling. Methods: This was a retrospective study based on data from the French Language Peritoneal Dialysis Registry. Patients incident on PD > 18 and < 65 years of age were included. Results: There were 2269 incidents of PD initiation between January 2008 and December 2012 in 127 PD centres with 114 (5%) on family-assisted PD and 272 (12%) on nurse-assisted PD. At the individual level, compared with autonomous patients, nurse assistance was associated with age {odds ratio [OR] 1.79 [95% confidence interval (CI) 1.51-2.13]}, gender [OR 0.47 (95% CI 0.35-0.64)], comorbidities and underlying nephropathy. There was significant heterogeneity between centres in the nurse assistance utilization (variance of random effect 0.12). At the centre level, the type of centre, centre experience, centre organization and private nurse density were not associated with nurse-assisted PD. Conclusions: The rate of nurse-assisted PD among non-elderly patients was 12%. There was a significant centre effect in the utilization of nurse assistance that was not explained by the centres' characteristics. Nurse-assisted PD utilization in non-elderly patients is associated with patient characteristics and also with centre practices.

Does the Blood Pump Flow Rate have an Impact on the Dialysis Dose During Low Dialysate Flow Rate Hemodialysis?

We conducted a prospective study to assess the impact of the blood pump flow rate (BFR) on the dialysis dose with a low dialysate flow rate. Seventeen patients were observed for 3 short hemodialysis sessions in which only the BFR was altered (300,350 and 450 mL/min). Kt/V urea increased from 0.54 ± 0.10 to 0.58 ± 0.08 and 0.61 ± 0.09 for BFR of 300, 400 and 450 mL/min. For the same BFR variations, the reduction ratio (RR) of ß2microglobulin increased from 0.40 ± 0.07 to 0.45 ± 0.06 and 0.48 ± 0.06 and the RR phosphorus increased from 0.46 ± 0.1 to 0.48 ± 0.08 and 0.49 ± 0.07. In bivariate analysis accounting for repeated observations, an increasing BFR resulted in an increase in spKt/V (0.048 per 100 mL/min increment in BPR [p < 0.05, 95% CI (0.03-0.06)]) and an increase in the RR ß2m (5% per 100 mL/min increment in BPR [p < 0.05, 95% CI (0.03-0.07)]). An increasing BFR with low dialysate improves the removal of urea and ß2m but with a potentially limited clinical impact.

Home hemodialysis treatment and outcomes: retrospective analysis of the Knowledge to Improve Home Dialysis Network in Europe (KIHDNEy) cohort.

BACKGROUND: Utilization of home hemodialysis (HHD) is low in Europe. The Knowledge to Improve Home Dialysis Network in Europe (KIHDNEy) is a multi-center study of HHD patients who have used a transportable hemodialysis machine that employs a low volume of lactate-buffered, ultrapure dialysate per session. In this retrospective cohort analysis, we describe patient factors, HHD prescription factors, and biochemistry and medication use during the first 6 months of HHD and rates of clinical outcomes thereafter. METHODS: Using a standardized digital form, we recorded data from 7 centers in 4 Western European countries. We retained patients who completed ≥6 months of HHD. We summarized patient and HHD prescription factors with descriptive statistics and used mixed modeling to assess trends in biochemistry and medication use. We also estimated long-term rates of kidney transplant and death. RESULTS: We identified 129 HHD patients; 104 (81%) were followed for ≥6 months. Mean age was 49 years and 66% were male. Over 70% of patients were prescribed 6 sessions per week, and the mean treatment duration was 15.0 h per week. Median HHD training duration was 2.5 weeks. Mean standard Kt/Vurea was nearly 2.7 at months 3 and 6. Pre-dialysis biochemistry was generally stable. Between baseline and month 6, mean serum bicarbonate increased from 23.1 to 24.1 mmol/L (P = 0.01), mean serum albumin increased from 36.8 to 37.8 g/L (P = 0.03), mean serum C-reactive protein increased from 7.3 to 12.4 mg/L (P = 0.05), and mean serum potassium decreased from 4.80 to 4.59 mmol/L (P = 0.01). Regarding medication use, the mean number of antihypertensive medications fell from 1.46 agents per day at HHD initiation to 1.01 agents per day at 6 months (P < 0.001), but phosphate binder use and erythropoiesis-stimulating agent dose were stable. Long-term rates of kidney transplant and death were 15.3 and 5.4 events per 100 patient-years, respectively. CONCLUSIONS: Intensive HHD with low-flow dialysate delivers adequate urea clearance and good biochemical outcomes in Western European patients. Intensive HHD coincided with a large decrease in antihypertensive medication use. With relatively rapid training, HHD should be considered in more patients.

Centre characteristics associated with the risk of peritonitis in peritoneal dialysis: a hierarchical modelling approach based on the data of the French Language Peritoneal Dialysis Registry.

BACKGROUND.: This study investigated the centre effect on the risk of peritonitis in peritoneal dialysis (PD) patients. METHODS.: This was a retrospective cohort study based on data from the French Language Peritoneal Dialysis Registry. We analysed 5017 incident patients starting PD between January 2008 and December 2012 in 127 PD centres. The end of the observation period was 1 January 2014. The event of interest was the first peritonitis episode. The analysis was performed with a multilevel Cox model and a Fine and Gray model. RESULTS.: Among the 5017 patients, 3190 peritonitis episodes occurred in 1796 patients. There was significant heterogeneity between centres (variance of the random effect: 0.11). The variance of the centre effect was reduced by 9% after adjusting for patient characteristics and by 35% after adjusting on centre covariate. In the multivariate analysis with a multilevel Cox model, centre with a nurse specialized in PD or centre providing home visits before dialysis initiation decreased the centre effect on peritonitis. Patients treated in centres with a nurse specialized in PD or in centres providing home visits before dialysis initiation had a lower risk of peritonitis [cause-specific hazard ratio (cs-HR): 0.75 (95% confidence interval, CI, 0.67-0.83) and cs-HR: 0.87 (95% CI 0.76-0.97), respectively]. The data show that neither centre type nor centre volume influenced peritonitis risk. In the competing risk analysis, centre with a nurse specialized in PD and centre with home visits had a protective effect on peritonitis [sub-distribution HR (sd-HR): 0.77 (95% CI 0.70-0.85) and sd-HR: 0.85 (95% CI 0.77-0.94), respectively]. CONCLUSION.: There is a significant centre effect on the risk of peritonitis that can be decreased by home visits before dialysis initiation and by the presence of a nurse specialized in PD.

Effect of assistance on peritonitis risk in diabetic patients treated by peritoneal dialysis: report from the French Language Peritoneal Dialysis Registry.

BACKGROUND: Diabetic patients treated by peritoneal dialysis (PD) have been reported to be at an increased risk of peritonitis. This has been attributed to impairment in host defense, visual impairment, disability and muscle wasting, which could compromise ability to safely perform catheter connections. This study aimed to evaluate whether assisted PD is associated with a lower risk of peritonitis in diabetic patients. METHODS: This was a retrospective study based on data from the French Language Peritoneal Dialysis Registry. We included diabetic patients starting PD between 1 January 2002 and 31 December 2012. The end of the observation period was 31 December 2013. Using complementary regression analysis (Fine and Gray, Hurdle models), we assessed the relationship between peritonitis occurrence, peritonitis number over time and the type of assisted PD. RESULTS: Of the 3598 diabetic patients, there were 2040 patients on nurse-assisted PD. These patients were older, more comorbid and more frequently on continuous ambulatory peritoneal dialysis (CAPD). In the multivariate analysis, nurse assistance was associated with a reduced risk of peritonitis in the Fine and Gray [subdistribution hazard ratio: 0.78 (95% confidence interval, CI, 0.68-0.89)] and in the first component of the Hurdle models [rate ratio: 0.82 (95% CI 0.71-0.93)], but not a lower incidence of peritonitis after an initial episode [rate ratio: 0.82 (95% CI 0.95-1.38)]. Transplant failure, glomerulonephritis and CAPD were associated with an increased risk. CONCLUSIONS: In France, nurse-assisted PD is associated with a lower risk of peritonitis in diabetic patients treated by PD but not a lower incidence of peritonitis.

Comparison between on-line high-efficiency hemodiafiltration and conventional high-flux hemodialysis for polyclonal free light chain removal.

BACKGROUND: Polyclonal free light chains (FLC) are considered as middle molecular weight uremic toxins in chronic kidney disease. In this study, we investigate polyclonal FLC removal by comparing conventional high-flux hemodialysis (HD) and online high-efficiency hemodiafiltration (ol-HDF) in end-stage renal disease patients. METHODS: We analyzed 31 chronic dialysis patients who were treated by HD then by postdilution ol-HDF during a prospective study. All patients were anuric and without monoclonal gammopathy. Serum pre- and postdialysis FLC were collected during 4 sessions: 1 HD session and 3 ol-HDF sessions. We calculated the reduction ratio using kinetic modeling. RESULTS: The κ reduction ratio was higher with ol-HDF than with HD (66 ± 14 vs. 52 ± 13%, p < 0.001). However, the λ reduction ratio was not significantly higher with ol-HDF (37 ± 20 vs. 37 ± 15%, p = 0.67). Furthermore, predialysis κ- and λ-FLC increased with ol-HDF compared with HD (κ 155 ± 82 vs. 87 ± 47 mg/l, p < 0.05; λ 101 ± 46 vs. 72 ± 41 mg/l, p < 0.05). Postdialysis FLC levels were raised only for λ-FLC with ol-HDF (74 ± 39 vs. 53 ± 31 mg/l, p < 0.05) and were not significantly different for κ. CONCLUSIONS: This study shows that κ-FLC removal is better in ol-HDF compared with HD, whereas there is no difference in λ-FLC removal. Surprisingly, predialysis κ and λ levels are both increased in ol-HDF, which is disturbing since polyclonal excess of λ-FLC is associated with mortality in chronic kidney disease.

Nurse-assisted arterio-venous fistula cannulation during home hemodialysis: first results of the DIADIDEAL study / La ponction de fistule assistée par infirmier libéral en hémodialyse à domicile : premiers résultats de l'étude DIADIDEAL.

Introduction: We have launched a pilot study, called DIADIDEAL, to propose nurse-assistance at home for arterio-venous fistula (AVF) cannulation in home hemodialysis (HHD) patients. The aim of the present study was to describe enrollment of the patients and their nurses. Materials: All prevalent HD patients on 30th November 2018 with no medical contraindication to HDD treatment and all incident patients on dialysis from the 30th November 2018 to the 21st April 2023 were eligible. Results: Among 155 prevalent HD patients, 4 patients were included. Among the 276 incident patients on dialysis during the study period, 6 were included. We have phoned 23 nurse centers during the recruitment period. Eight of them agreed to learn in our unit how to cannulate AVF; 27 private nurses were enrolled. Discussion: The results of the DIADIDEAL study will be available in 2024; we hope it will lead to a reimbursement of nurse-AVF cannulation at home in HDD.

Introduction: L'étude DIADIDEAL est une étude pilote sur la ponction de fistule artério-veineuse (FAV) assistée par infirmier libéral en hémodialyse à domicile (HDD). L'objectif de l'étude actuelle est de rapporter le recrutement des patients et de leurs infirmiers diplômés d'État libéraux (IDEL). Matériels et méthodes: Tous les patients prévalents en HD au 30 novembre 2018 n'ayant pas de contre-indication médicale à un traitement par HDD ainsi que tous les patients incidents en dialyse du 30 novembre 2018 au 21 avril 2023 étaient éligibles. Résultats: Parmi les 155 patients prévalents en hémodialyse, 4 ont été inclus. Parmi les 276 patients incidents en dialyse sur la période, 6 ont été inclus dans l'étude. Parmi les 23 cabinets IDEL contactés pour l'étude, 8 ont accepté et 27 IDEL ont été formés à la ponction de FAV. Discussion: Les résultats de l'étude DIADIDEAL seront disponibles en 2024 et viseront à obtenir une nomenclature pour l'acte de ponction de FAV par les IDEL.

Transfers from home to facility-based dialysis: comparisons of HHD, assisted PD and autonomous PD.

Background: Home dialysis therapies such as peritoneal dialysis (PD) and home hemodialysis (HHD) are beneficial for quality of life and patient empowerment. The short technique survival time partly explains their low prevalence. We aimed to assess the risk of transfer to facility-based hemodialysis in patients treated with autonomous PD, assisted PD and HHD. Methods: This was a retrospective study using data from the REIN registry of patients starting home dialysis in France from 2002 to 2019. The risks of transfer to facility-based hemodialysis (HD) were compared between three modalities of home dialysis (HHD, nurse-assisted PD, autonomous PD) using survival models with a propensity score (PS)-matched and unmatched cohort of patients. Results: The study included 17 909 patients: 628 in the HHD group, 10 214 in the autonomous PD group, and 7067 in the assisted PD group. During the follow-up period, there were 5347 transfers to facility-based HD. The observed number of transfers was 2458 (13.7%) at 1 year and 5069 (28.3) at 5 years after the start of home dialysis, including 3272 (32%) on autonomous PD, 1648 (23.3%) on assisted PD, and 149 (23.7) on HHD. Owing to clinical characteristics differences, only 38% of HHD patients could be matched to patients from the others group. In the PS-matched cohort, the adjusted Cox model showed no difference in the risk of transfer for assisted PD (cs-HR 1.04, 95% CI 0.75-1.44) or HHD (cs-HR 1.07, 95% CI 0.77-1.48) compared with autonomous PD. Conclusions: Unlike results from other countries, where nurse assistance is not fully available for PD-associated care, there was no difference in technique survival between autonomous PD, nurse-assisted PD, and HHD in France. This discrepancy may be attributed to our inclusion of a broader spectrum of patients who derive significant benefits from assisted PD.

Successful rescue TNF-α blocking for Mycobacterium genavense - Related immune reconstitution inflammatory syndrome: A case report.

Immune reconstitution inflammatory syndrome (IRIS) has been reported in immunocompromised patients with disseminated Mycobacterium genavense. Management relies on high-dose corticosteroids. We describe two cases of late-onset corticosteroid-refractory IRIS related to disseminated infection in a HIV-positive patient and a renal transplant patient who had a favorable outcome with a monoclonal TNF-α blocker.

Safety and efficacy of apixaban versus warfarin in peritoneal dialysis patients with non-valvular atrial fibrillation: protocol for a prospective, randomised, open-label, blinded endpoint trial (APIDP2).

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.