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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00966615
Enrollment
68
Registered
2009-08-27
Start date
2010-09-30
Completion date
2014-09-30
Last updated
2014-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, ESRD, Renal Failure

Keywords

malnutrition, fluid status, survival

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)

Interventions

OTHERdouble-chamber bag Stay-Safe Balance system

2-L exchange; three times a day

OTHERglucose-based dialysis solution

2-L exchange; three times a day

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
body composition52 weeks
arterial pulse wave velocity52 weeks

Secondary

MeasureTime frame
residual renal function52 weeks
nutritional and adequacy indices52 weeks
hospitalization52 weeks
peritonitis-free survival, actuarial and technique survival52 weeks
peritoneal transport characteristics52 weeks

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026