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

The Chinese University of Hong Kong

Status and phase: Completed; Phase 4

Conditions: Renal Failure; ESRD; Cardiovascular Disease

Treatments: Other: double-chamber bag Stay-Safe Balance system; Other: glucose-based dialysis solution

Study type: Interventional

Funder types: Other

Identifiers

NCT00966615

Balance BCM

Details and patient eligibility

About

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.

Full description

(see above)

Enrollment: 68 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Balance group

Experimental group

Description:

peritoneal dialysis with neutral peritoneal dialysis solution with minimal glucose-degradation-product

Treatment:

Other: double-chamber bag Stay-Safe Balance system

Control group

Active Comparator group

Description:

conventional PD solution

Treatment:

Other: glucose-based dialysis solution