A New Cycler for Automated Peritoneal Dialysis to Provide Efficient Dialysis and Improved Sleep Quality.

INTRODUCTION: Automated peritoneal dialysis (APD) employs cyclers to control inflow and outflow of the dialysis fluid to the patient's abdomen. To allow more patients to use this modality, cyclers should support the achievement of an adequate dialysis dose and be easy to use, cost-effective, and silent. The new SILENCIA cycler (Fresenius Medical Care, Bad Homburg, Germany), designed to improve these characteristics in comparison to its predecessor device, was evaluated in this respect in a prospective study. METHODS: This cross-over study comprised two 2-week study periods, separated by a 3-week training phase. First, patients underwent APD with their current cycler (PD-NIGHT [Fresenius Medical Care, Bad Homburg, Germany] or HomeChoice Pro [Baxter, Deerfield, IL, USA] as control), followed by training on the SILENCIA cycler. Then, patients were switched to the SILENCIA cycler. During each treatment period, we collected data on total Kt/Vurea, ultrafiltration (UF) volume, patient-reported outcomes (sleep quality, among others), and device handling. RESULTS: Sixteen patients were enrolled; 2 patients terminated the study prematurely before study intervention, 1 patient due to a protocol violation. In 13 patients, total Kt/Vurea and UF could be evaluated. Neither Kt/Vurea nor UF differed significantly between control and SILENCIA cyclers. Out of 10 patients answering the questionnaire on sleep quality after the 2-week phase with the SILENCIA cycler, sleep quality improved in 5 patients; in the other patients, sleep quality was rated unchanged compared to the previously used cycler. The average reported sleep time was 5.9 ± 1.8 h with the PD-NIGHT, 7.2 ± 2.1 h with HomeChoice Pro, and 8.0 ± 1.6 h with the SILENCIA cycler. All patients were much or very much satisfied with the new cycler. CONCLUSION: The SILENCIA cycler delivers adequate urea clearance and UF. Importantly, sleep quality improved, possibly related to less caution messages and alarms.

Current clinical practice in adapted automated peritoneal dialysis (aAPD)-A prospective, non-interventional study.

Adapted automated peritoneal dialysis (aAPD), comprising a sequence of dwells with different durations and fill volumes, has been shown to enhance both ultrafiltration and solute clearance compared to standard peritoneal dialysis with constant time and volume dwells. The aim of this non-interventional study was to describe the different prescription patterns used in aAPD in clinical practice and to observe outcomes characterizing volume status, dialysis efficiency, and residual renal function over 1 year. Prevalent and incident, adult aAPD patients were recruited during routine clinic visits, and aAPD prescription, volume status, residual renal function and laboratory data were documented at baseline and every quarter thereafter for 1 year. Treatments were prescribed according to the nephrologist's medical judgement in accordance with each center's clinical routine. Of 180 recruited patients, 160 were analyzed. 27 different aAPD prescription patterns were identified. 79 patients (49.4%) received 2 small, short dwells followed by 3 long, large dwells. During follow-up, volume status changed only marginally, with visit mean values ranging between 1.59 (95% confidence interval: 1.19; 1.99) and 1.97 (1.33; 2.61) L. Urine output and creatinine clearance decreased significantly, accompanied by reductions in ultrafiltration and Kt/V. 25 patients (15.6%) received a renal transplant and 15 (9.4%) were changed to hemodialysis. Options for individualization offered by aAPD are actually used in practice for optimized treatment. Changes observed in renal function and dialysis efficiency measures reflect the natural course of chronic kidney disease. No safety events were observed during the study period.

The impact of volume overload on technique failure in incident peritoneal dialysis patients.

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.

Association of Prescription With Body Composition and Patient Outcomes in Incident Peritoneal Dialysis Patients.

Objective: The nutritional status of patients on peritoneal dialysis (PD) is influenced by patient- and disease-related factors and lifestyle. This analysis evaluated the association of PD prescription with body composition and patient outcomes in the prospective incident Initiative for Patient Outcomes in Dialysis-Peritoneal Dialysis (IPOD-PD) patient cohort. Design and Methods: In this observational, international cohort study with longitudinal follow-up of 1,054 incident PD patients, the association of PD prescription with body composition was analyzed by using the linear mixed models, and the association of body composition with death and change to hemodialysis (HD) by means of a competing risk analysis combined with a spline analysis. Body composition was regularly assessed with the body composition monitor, a device applying bioimpedance spectroscopy. Results: Age, time on PD, and the use of hypertonic and polyglucose solutions were significantly associated with a decrease in lean tissue index (LTI) and an increase in fat tissue index (FTI) over time. Competing risk analysis revealed a U-shaped association of body mass index (BMI) with the subdistributional hazard ratio (HR) for risk of death. High LTI was associated with a lower subdistributional HR, whereas low LTI was associated with an increased subdistributional HR when compared with the median LTI as a reference. High FTI was associated with a higher subdistributional HR when compared with the median as a reference. Subdistributional HR for risk of change to HD was not associated with any of the body composition parameters. The use of polyglucose or hypertonic PD solutions was predictive of an increased probability of change to HD, and the use of biocompatible solutions was predictive of a decreased probability of change to HD. Conclusion: Body composition is associated with non-modifiable patient-specific and modifiable treatment-related factors. The association between lean tissue and fat tissue mass and death and change to HD in patients on PD suggests developing interventions and patient counseling to improve nutritional markers and, ultimately, patient outcomes. Study Registration: The study has been registered at Clinicaltrials.gov (NCT01285726).

Evolution Over Time of Volume Status and PD-Related Practice Patterns in an Incident Peritoneal Dialysis Cohort.

BACKGROUND AND OBJECTIVES: Volume 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, & MEASUREMENTS: This 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. RESULTS: In 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. CONCLUSIONS: In 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.

Effect of balance Solution on the Peritoneal Membrane in Automated Peritoneal Dialysis.

Interference of conventional peritoneal dialysis fluids (cPDFs) with peritoneal membrane cell functions may be attributed to the dialysis fluid's low pH, high glucose concentration, and/or the presence of glucose degradation products (GDPs), the last of which leads to higher levels of advanced glycation end-products (AGEs). It has been suggested that the peritoneal membrane might be better preserved by using biocompatible solutions, including cancer antigetn 125 (CA125). This prospective, open-label, multicentre, randomized, controlled, cross-over phase IV study compared the in vivo biocompatibility of a neutral-pH, low-GDP peritoneal dialysis (PD) solution (balance) with a cPDF in automated PD (APD) patients. Our study revealed a significantly increased appearance rate and concentration of CA125 in the peritoneal effluent of APD patients treated with the neutral-pH, low-GDP solution balance versus a conventional PD solution.

Baseline hydration status in incident peritoneal dialysis patients: the initiative of patient outcomes in dialysis (IPOD-PD study)†.

BACKGROUND: Non-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. METHODS: The 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. RESULTS: A 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. CONCLUSIONS: The 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.

Biocompatibility and tolerability of a purely bicarbonate-buffered peritoneal dialysis solution.

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-alpha), interleukin 6 (IL-6), interferon gamma (IFNgamma), and transforming growth factor-beta(1) (TGF-beta1). 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-alpha and TGF-beta1 showed higher levels with the use of bicPDF than with SPDF. No differences were observed for IL-6, VEGF, or IFNgamma 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.