The Effect of Neutral Peritoneal Dialysis (PD) Solution With Minimal Glucose-Degradation-Product (GDP) on Fluid Status and Body Composition

Phase 4

Completed

• Conditions: Cardiovascular Disease; Renal Failure; ESRD
• Interventions: Other: double-chamber bag Stay-Safe Balance system; Other: glucose-based dialysis solution

• Registration Number: NCT00966615
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

Chronic utilization of bio-incompatible peritoneal dialysis (PD) solution has been implicated as a cause of progressive loss of peritoneal permeability and recurrent fluid overload in PD patients. Previous studies show that PD solution with neutral pH and low GDP resulted in a superior profile of PD effluent mesothelial cell marker and a lower degree of systemic inflammation as compared to conventional PD solution. The investigators propose a prospective randomized control study to compare the arterial stiffness, nutrition and body fluid status between PD patients treated with conventional solution and those with neutral pH low GDP solution. The investigators plan to study 100 new PD patients. They will be randomized to be treated with neutral pH low GDP solution or conventional solution. All patients will be followed for 52 weeks. In addition to routine clinical measurements, the investigators will measure their body water composition by bioimpedance spectroscopic method, arterial pulse wave velocity by pressure transduction method, as well as radiographic parameters of intravascular volume status, based on the routine chest radiograph. The study would help to define the clinical benefit of biocompatible PD solution.

Detailed Description

(see above)

Study Timeline

• Study First Submitted: 2009-08-26
• Study First Submitted QC: 2009-08-26
• Study First Posted: 2009-08-27
• Study Start: 2010-09
• Status Verified: 2014-09
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Last Update Submitted: 2014-09-04
• Last Update Posted: 2014-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• new adult continuous ambulatory peritoneal dialysis (CAPD) patients, both diabetic and non-diabetic

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Exclusion Criteria

• unlikely to survive, planned to have elective living-related kidney transplant, or transfer to other renal center within 6 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Balance group	double-chamber bag Stay-Safe Balance system	peritoneal dialysis with neutral peritoneal dialysis solution with minimal glucose-degradation-product
Control group	glucose-based dialysis solution	conventional PD solution

Primary Outcome Measures

Name	Time	Method
body composition	52 weeks
arterial pulse wave velocity	52 weeks

Secondary Outcome Measures

Name	Time	Method
peritoneal transport characteristics	52 weeks
hospitalization	52 weeks
residual renal function	52 weeks
nutritional and adequacy indices	52 weeks
peritonitis-free survival, actuarial and technique survival	52 weeks

Trial Locations

Locations (1)

Department of Medicine & Therapeutics, Prince of Wales Hospital; 🇭🇰 Sha Tin, Hong Kong