Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cheuk-Chun SZETO, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00966615
First received: August 26, 2009
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Renal Failure
ESRD
Cardiovascular Disease
Other: double-chamber bag Stay-Safe Balance system
Other: glucose-based dialysis solution
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Neutral Peritoneal Dialysis Solution With Minimal Glucose-Degradation-Product on the Fluid Status and Body Composition - A Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • body composition [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • arterial pulse wave velocity [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • nutritional and adequacy indices [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • peritoneal transport characteristics [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • residual renal function [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • peritonitis-free survival, actuarial and technique survival [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • hospitalization [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 68
Study Start Date: September 2010
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Balance group
peritoneal dialysis with neutral peritoneal dialysis solution with minimal glucose-degradation-product
Other: double-chamber bag Stay-Safe Balance system
2-L exchange; three times a day
Other Name: Stay-Safe Balance system
Active Comparator: Control group
conventional PD solution
Other: glucose-based dialysis solution
2-L exchange; three times a day
Other Name: Stay-Safe, Fresenius

Detailed Description:

(see above)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00966615

Locations
Hong Kong
Department of Medicine & Therapeutics, Prince of Wales Hospital
Sha Tin, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Cheuk Chun Szeto, MD Chinese University of Hong Kong
Study Director: Philip KT Li, MD Prince of Wales Hospital, Shatin, Hong Kong
  More Information

No publications provided

Responsible Party: Cheuk-Chun SZETO, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00966615     History of Changes
Other Study ID Numbers: Balance BCM
Study First Received: August 26, 2009
Last Updated: September 4, 2014
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
malnutrition
fluid status
survival

Additional relevant MeSH terms:
Cardiovascular Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Dialysis Solutions
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014