NCT00966615

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Renal Failure
• ESRD
• Cardiovascular Disease

Interventions

Type	Name	Description
OTHER	double-chamber bag Stay-Safe Balance system	2-L exchange; three times a day
OTHER	glucose-based dialysis solution	2-L exchange; three times a day

Timeline

• Start date: 2010-09-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2009-08-27
• Last updated: 2014-09-08

Locations

1 site across 1 country: Hong Kong