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

NCT00966615 | Completed Phase 4

• 1 other identifier: Balance BCM
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Failure; ESRD; Cardiovascular Disease

Keywords

malnutrition; fluid status; survival

Outcome Measures

Primary Outcomes (2)

• body composition

  52 weeks

• arterial pulse wave velocity

  52 weeks

Secondary Outcomes (5)

• nutritional and adequacy indices

  52 weeks

• peritoneal transport characteristics

  52 weeks

• residual renal function

  52 weeks

• peritonitis-free survival, actuarial and technique survival

  52 weeks

• hospitalization

  52 weeks

Study Arms (2)

Balance group

EXPERIMENTAL

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

Other: double-chamber bag Stay-Safe Balance system

Control group

ACTIVE COMPARATOR

conventional PD solution

Other: glucose-based dialysis solution

Interventions

double-chamber bag Stay-Safe Balance system OTHER

2-L exchange; three times a day

Also known as: Stay-Safe Balance system

Balance group

glucose-based dialysis solution OTHER

2-L exchange; three times a day

Also known as: Stay-Safe, Fresenius

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Medicine & Therapeutics, Prince of Wales Hospital

Shatin, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 26510186 DERIVED

MeSH Terms

Conditions

Renal Insufficiency; Kidney Failure, Chronic; Cardiovascular Diseases; Malnutrition

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Cheuk Chun Szeto, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

• Philip KT Li, MD

  Prince of Wales Hospital, Shatin, Hong Kong

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 26, 2009
• First Posted: August 27, 2009
• Study Start: September 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 8, 2014

Record last verified: 2014-09

Locations

HK (1)