Background and objectivesVolume overload is frequent in prevalent patients on kidney replacement therapies and is associated with outcome. This study was devised to follow-up volume status of an incident population on peritoneal dialysis (PD) and to relate this to patient-relevant outcomes.Design, setting, participants, & measurementsThis prospective cohort study was implemented in 135 study centers from 28 countries. Incident participants on PD were enrolled just before the actual PD treatment was started. Volume status was measured using bioimpedance spectroscopy before start of PD and thereafter in 3-month intervals, together with clinical and laboratory parameters, and PD prescription. The association of volume overload with time to death was tested using a competing risk Cox model.ResultsIn this population of 1054 participants incident on PD, volume overload before start of PD amounted to 1.9±2.3 L, and decreased to 1.2±1.8 L during the first year. At all time points, men and participants with diabetes were at higher risk to be volume overloaded. Dropout from PD during 3 years of observation by transfer to hemodialysis or transplantation (23% and 22%) was more prevalent than death (13%). Relative volume overload >17.3% was independently associated with higher risk of death (adjusted hazard ratio, 1.59; 95% confidence interval, 1.08 to 2.33) compared with relative volume overload ≤17.3%. Different practice patterns were observed between regions with respect to proportion of patients on PD versus hemodialysis, selection of PD modality, and prescription of hypertonic solutions.ConclusionsIn this large cohort of incident participants on PD, with different treatment practices across centers and regions, we found substantial volume overload already at start of dialysis. Volume overload improved over time, and was associated with survival.

BackgroundNon-euvolaemia in peritoneal dialysis (PD) patients is associated with elevated mortality risk. There is an urgent need to collect data to help us understand the association between clinical practices and hydration and nutritional status, and their effects on patient outcome.MethodsThe aim of this prospective international, longitudinal observational cohort study is to follow up the hydration and nutritional status, as measured by bioimpedance spectroscopy using the body composition monitor (BCM) of incident PD patients for up to 5 years. Measures of hydration and nutritional status and of clinical, biochemical and therapy-related data are collected directly before start of PD treatment, at 1 and 3 months, and then every 3 months. This paper presents the protocol and a pre-specified analysis of baseline data of the cohort.ResultsA total of 1092 patients (58.1% male, 58.0 ± 15.3 years) from 135 centres in 32 countries were included. Median fluid overload (FO) was 2.0 L (males) and 0.9 L (females). Less than half of the patients were normohydrated (38.7%), whereas FO > 1.1 L was seen in 56.5%. Systolic and diastolic blood pressure were 139.5 ± 21.8 and 80.0 ± 12.8 mmHg, respectively, and 25.1% of patients had congestive heart failure [New York Heart Association (NYHA) 1 or higher]. A substantial number of patients judged to be not overhydrated on clinical judgement appeared to be overhydrated by BCM measurement. Overhydration at baseline was independently associated with male gender and diabetic status.ConclusionsThe majority of patients starting on PD are overhydrated already at start of PD. This may have important consequences on clinical outcomes and preservation of residual renal function. Substantial reclassification of hydration status by BCM versus on a clinical basis was necessary, especially in patients who were not overtly overhydrated. Both clinical appreciation and bioimpedance should be combined in clinical decision-making on hydration status.

Background Technique failure in peritoneal dialysis (PD) can be due to patient- and procedure-related factors. With this analysis, we investigated the association of volume overload at the start and during the early phase of PD and technique failure. Methods In this observational, international cohort study with longitudinal follow-up of incident PD patients, technique failure was defined as either transfer to haemodialysis or death, and transplantation was considered as a competing risk. We explored parameters at baseline or within the first 6 months and the association with technique failure between 6 and 18 months, using a competing risk model. Results Out of 1092 patients of the complete cohort, 719 met specific inclusion and exclusion criteria for this analysis. Being volume overloaded, either at baseline or Month 6, or at both time points, was associated with an increased risk of technique failure compared with the patient group that was euvolaemic at both time points. Undergoing treatment at a centre with a high proportion of PD patients was associated with a lower risk of technique failure. Conclusions Volume overload at start of PD and/or at 6 months was associated with a higher risk of technique failure in the subsequent year. The risk was modified by centre characteristics, which varied among regions.

Background Novel peritoneal dialysis solutions are characterized by a minimal content of glucose degradation products and a neutral pH. Many studies have shown the biocompatibility of neutral lactate-buffered solutions; however, until now, the effect of purely bicarbonate-buffered solutions has not been intensively studied in vivo. Methods This study was an open label, prospective, crossover multicenter trial to investigate the biocompatibility of a purely bicarbonate-buffered solution (bicPDF) by measuring biocompatibility parameters such as cancer antigen 125 (CA125) in peritoneal effluent. 55 patients were enrolled in the study. After a 2-week run-in phase, 53 patients could be randomized into 2 groups, starting with either standard lactate-buffered peritoneal dialysis fluid (SPDF) for 12 weeks (phase 1) and then switching to bicPDF for 12 weeks (phase 2), or vice versa. Overnight peritoneal effluents were collected at baseline and at the end of phases 1 and 2 and were tested for CA125, hyaluronic acid, vascular endothelial growth factor (VEGF), tumor necrosis factor-alpha (TNF-α), interleukin 6 (IL-6), interferon gamma (IFNγ), and transforming growth factor-beta1 (TGF-β1). Total ultrafiltration and residual renal function were also assessed. At the end of the study, pain during fluid exchange and dwell was evaluated using special questionnaires. Results 34 patients completed the study; 27 of them provided data for analysis of the biocompatibility parameters. CA125 levels in overnight effluent were significantly higher with bicPDF (61.9 ± 33.2 U/L) than with SPDF (18.6 ± 18.2 U/L, p < 0.001). Hyaluronic acid levels were significantly lower after the use of bicPDF (185.0 ± 119.6 ng/mL) than after SPDF (257.4 ± 174.0 ng/mL, p = 0.013). Both TNF-α and TGF-β1 showed higher levels with the use of bicPDF than with SPDF. No differences were observed for IL-6, VEGF, or IFNγ levels. We observed an improvement in the glomerular filtration rate with the use of bicPDF but no differences were observed for total fluid loss. Pain scores could be analyzed in 23 patients: there was no difference between the solutions. Conclusions The use of a purely bicarbonate-buffered low-glucose degradation product solution significantly changes most of the peritoneal effluent markers measured, suggesting an improvement in peritoneal membrane integrity. Additionally, it seems to have a positive effect on residual renal function.

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