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Abstract
BackgroundThe main hypothesis of this study is that neutral pH, low glucose degradation product (GDP) peritoneal dialysis (PD) fluid better preserves residual renal function in PD patients over time compared with conventional dialysate.Methods/DesignInclusion criteria are adult PD patients (CAPD or APD) aged 18-81 years whose first dialysis was within 90 days prior to or following enrolment and who have a residual GFR ≥ 5 ml/min/1.73 m2, a urine output ≥ 400 ml/day and an ability to understand the nature and requirements of this trial. Pregnant or lactating patients or individuals with an active infection at the time of enrolment, a contra-indication to PD or participation in any other clinical trial where an intervention is designed to moderate rate of change of residual renal function are excluded. Patients will be randomized 1:1 to receive either neutral pH, low GDP dialysis solution (Balance®) or conventional dialysis solution (Stay.safe®) for a period of 2 years. During this 2 year study period, urinary urea and clearance measurements will be performed at 0, 3, 6, 9, 12, 18 and 24 months. The primary outcome measure will be the slope of residual renal function decline, adjusted for centre and presence of diabetic nephropathy. Secondary outcome measures will include time from initiation of peritoneal dialysis to anuria, peritoneal small solute clearance, peritoneal transport status, peritoneal ultrafiltration, technique survival, patient survival, peritonitis rates and adverse events. A total of 185 patients has been recruited into the trial.DiscussionThis investigator-initiated study has been designed to provide evidence to help nephrologists determine the optimal dialysis solution for preserving residual renal function in PD patients.Trial RegistrationAustralian New Zealand Clinical Trials Registry Number: ACTRN12606000044527
Highlights
The main hypothesis of this study is that neutral pH, low glucose degradation product (GDP) peritoneal dialysis (PD) fluid better preserves residual renal function in PD patients over time compared with conventional dialysate
The current multi-centre, randomised controlled study is designed to ask whether neutral pH, low GDP peritoneal dialysis fluid better preserves residual renal function in PD patients over a 2 year period compared with conventional dialysate
Given that numerous studies have demonstrated that PD patients with rapid residual renal function decline are at significantly increased risk of mortality [26,27,28], novel treatments for preserving residual renal function in this group may represent an important strategy for improving clinical outcomes in PD patients
Summary
This investigator-initiated, multicentre Australian, New Zealand and Singapore study has been designed to provide evidence to help nephrologists and their PD patients better determine the optimal dialysis solution for preserving residual renal function. In the event of a negative study finding, which might potentially reflect a type 2 statistical error, the ability to detect a smaller benefit of biocompatible fluids on residual renal function decline could still be possible as a result of incorporation of the balANZ trial data into a meta-analysis of all randomised controlled trials of biocompatible fluids versus conventional biocompatible fluids currently being undertaken by the Cochrane Renal Group [33] Such a systematic review may help to determine whether biocompatible fluids influence patient-level outcomes, such as technique survival and patient survival, for which all studies to date have been significantly underpowered.
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