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

Cardiovascular Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00966615
• Other study ID #: Balance BCM
• Status: Completed
• Phase: Phase 4
• First received: August 26, 2009
• Last updated: September 4, 2014
• Start date: September 2010
• Est. completion date: September 2014

Study information

• Verified date: September 2014
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

(see above)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• ESRD
• Renal Failure

Intervention

Other:
• double-chamber bag Stay-Safe Balance system
2-L exchange; three times a day
• glucose-based dialysis solution
2-L exchange; three times a day

Locations

Country	Name	City	State
Hong Kong	Department of Medicine & Therapeutics, Prince of Wales Hospital	Sha Tin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body composition		52 weeks	No
Primary	arterial pulse wave velocity		52 weeks	No
Secondary	nutritional and adequacy indices		52 weeks	No
Secondary	peritoneal transport characteristics		52 weeks	No
Secondary	residual renal function		52 weeks	No
Secondary	peritonitis-free survival, actuarial and technique survival		52 weeks	No
Secondary	hospitalization		52 weeks	No