Rationale and design of the balANZ trial: A randomised controlled trial of low GDP, neutral pH versus standard peritoneal dialysis solution for the preservation of residual renal function

Johnson, DW, Clarke, M, Wilson, V, Woods, F and Brown, FG (2010) Rationale and design of the balANZ trial: A randomised controlled trial of low GDP, neutral pH versus standard peritoneal dialysis solution for the preservation of residual renal function. BMC Nephrology, 11 1: 25-1-25-7. doi:10.1186/1471-2369-11-25


Author Johnson, DW
Clarke, M
Wilson, V
Woods, F
Brown, FG
Title Rationale and design of the balANZ trial: A randomised controlled trial of low GDP, neutral pH versus standard peritoneal dialysis solution for the preservation of residual renal function
Journal name BMC Nephrology   Check publisher's open access policy
ISSN 1471-2369
Publication date 2010-09-01
Sub-type Article (original research)
DOI 10.1186/1471-2369-11-25
Open Access Status DOI
Volume 11
Issue 1
Start page 25-1
End page 25-7
Total pages 7
Place of publication London, United Kingdom
Publisher BioMed Central
Language eng
Formatted abstract
Background. 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. Methods/Design. Inclusion 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.
Discussion. This 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 Registration. Australian New Zealand Clinical Trials Registry Number: ACTRN12606000044527
© 2010 Johnson et al; licensee BioMed Central Ltd.
Keyword Glucose-degradation products
Patient survival
Capd patients
Membrane
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ
Additional Notes Under heading: 'Study Protocol'

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2011 Collection
School of Medicine Publications
 
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Created: Wed, 23 Mar 2011, 18:59:02 EST by Debbie Banks on behalf of Medicine - Princess Alexandra Hospital