The Trio Trial - A Randomized Controlled Clinical Trial Evaluating the Effect of a Biocompatible Peritoneal Dialysis Solution on Residual Renal Function.
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OBJECTIVE
Residual renal function (RRF) correlates with mortality and morbidity rates in patients receiving peritoneal dialysis (PD). We examined the effect of a biocompatible PD solution (Gambrosol Trio; Gambro Lundia AB, Lund, Sweden) with lower concentrations of glucose degradation products on rates of decline in RRF. ♦


METHODS
Incident patients at 2 centers in Canada and 1 in Hong Kong were randomized (by minimization) in an open-label parallel group trial to receive Gambrosol Trio or standard PD solution (Dianeal; Baxter Healthcare, Mississauga, Canada) for 2 years. Primary outcome was slope of RRF. Secondary outcomes were urine volumes, fluid and nutrition indices, PD and membrane characteristics, peritonitis rates, adverse events, and PD technique survival. ♦


RESULTS
Residual renal function declined by 0.132 mL/minute/1.73 m(2)/month in 51 patients allocated to biocompatible, and 0.174 mL/minute/1.73 m(2)/month in 50 patients allocated to standard PD solution (difference 0.042 mL/minute/1.73 m(2)/month, p = 0.001). Urine volume, body mass index, normalized protein catabolic rates, and fat mass were higher; total body water, peritoneal ultrafiltration, and D/P creatinine did not differ; and serum phosphate, rates of icodextrin, and automated cycler use were lower with Gambrosol Trio use. There were more peritonitis events with Gambrosol Trio use, while PD technique survival did not differ between groups. ♦


CONCLUSIONS
The use of the biocompatible PD solution Gambrosol Trio was associated with slower rates of decline in RRF, fluid and nutrition benefits, and increased peritonitis rates.


BACKGROUND
ISRCTN26252543.
Department of Nephrology, The Scarborough Hospital, Scarborough, ON, Canada tabosikaneta@yahoo.ca.
Tabo
T
Sikaneta
Department of Medicine, Credit Valley Hospital, Mississauga, ON, Canada.
George
G
Wu
Division of Radiology, Dalhousie University, Halifax, NS, Canada.
Mohamed
M
Abdolell
Research Department, Kidney Life Sciences Institute, Scarborough, ON, Canada.
Anita
A
Ng
Department of Nephrology, The Scarborough Hospital, Scarborough, ON, Canada.
Sara
S
Mahdavi
Statistician, Private Statistics Consultants, Toronto, ON, Canada.
Anton
A
Svendrovski
Research Department, Kidney Life Sciences Institute, Scarborough, ON, Canada.
Tony
T
Tu
Department of Medicine, Credit Valley Hospital, Mississauga, ON, Canada.
Trish
T
Mercer
Medicine & Geriatrics, Princess Margaret Hospital, Hong Kong.
Matthew
M
Tong
Department of Nephrology, University Health Network, Toronto, ON, Canada.
Dimitrios
D
Oreopoulos
Department of Nephrology, The Scarborough Hospital, Scarborough, ON, Canada.
Paul
P
Tam
D000368:Aged; D001672:Biocompatible Materials / Q000627:therapeutic use*; D002170:Canada; D015314:Dialysis Solutions / Q000009:adverse effects / Q000737:chemistry*; D005260:Female; D005500:Follow-Up Studies; D005919:Glomerular Filtration Rate / Q000502:physiology*; D006723:Hong Kong; D006801:Humans; D053208:Kaplan-Meier Estimate; D007676:Kidney Failure, Chronic / Q000175:diagnosis / Q000628:therapy; D007677:Kidney Function Tests; D008297:Male; D008875:Middle Aged; D010530:Peritoneal Dialysis / Q000009:adverse effects / Q000379:methods*; D010538:Peritonitis / Q000209:etiology / Q000517:prevention & control*; D016016:Proportional Hazards Models; D018570:Risk Assessment; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
D001672:Biocompatible Materials; D015314:Dialysis Solutions
Peritoneal dialysis; biocompatible PD solutions; peritonitis; residual renal function