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

NCT ID: NCT00966615

Last Updated: 2014-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2014-09-30

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)

Conditions

Renal Failure; ESRD; Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Balance group

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

Group Type: EXPERIMENTAL

double-chamber bag Stay-Safe Balance system

Intervention Type: OTHER

2-L exchange; three times a day

Control group

conventional PD solution

Group Type: ACTIVE_COMPARATOR

glucose-based dialysis solution

Intervention Type: OTHER

2-L exchange; three times a day

Interventions

double-chamber bag Stay-Safe Balance system

2-L exchange; three times a day

Intervention Type: OTHER

glucose-based dialysis solution

2-L exchange; three times a day

Intervention Type: OTHER

Other Intervention Names

Stay-Safe Balance system; Stay-Safe, Fresenius

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Cheuk-Chun SZETO

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cheuk Chun Szeto, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Philip KT Li, MD

Role: STUDY_DIRECTOR

Prince of Wales Hospital, Shatin, Hong Kong

Locations

Department of Medicine & Therapeutics, Prince of Wales Hospital

Shatin, , Hong Kong

Countries

Hong Kong

References

Szeto CC, Kwan BC, Chow KM, Cheng PM, Kwong VW, Choy AS, Law MC, Leung CB, Li PK. The Effect of Neutral Peritoneal Dialysis Solution with Low Glucose-Degradation-Product on the Fluid Status and Body Composition--A Randomized Control Trial. PLoS One. 2015 Oct 28;10(10):e0141425. doi: 10.1371/journal.pone.0141425. eCollection 2015.

Reference Type: DERIVED

PMID: 26510186 (View on PubMed)

Other Identifiers

Balance BCM

Identifier Type: -

Identifier Source: org_study_id