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Clinical Trials/NCT00966615
NCT00966615
Completed
Phase 4

The Effect of Neutral Peritoneal Dialysis Solution With Minimal Glucose-Degradation-Product on the Fluid Status and Body Composition - A Randomized Control Trial

Chinese University of Hong Kong1 site in 1 country68 target enrollmentSeptember 2010

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Renal Failure
Sponsor
Chinese University of Hong Kong
Enrollment
68
Locations
1
Primary Endpoint
body composition
Status
Completed
Last Updated
11 years ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
September 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cheuk-Chun SZETO

Professor

Chinese University of Hong Kong

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

body composition

Time Frame: 52 weeks

arterial pulse wave velocity

Time Frame: 52 weeks

Secondary Outcomes

  • 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)

Study Sites (1)

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