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NCT Number: NCT00966615

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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Medicine & Therapeutics, Prince of Wales Hospital

Shatin, Hong Kong

About this study

(see above)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

double-chamber bag Stay-Safe Balance system

Other

2-L exchange; three times a day

Other names: Stay-Safe Balance system

glucose-based dialysis solution

Other

2-L exchange; three times a day

Other names: Stay-Safe, Fresenius

Primary outcomes

  1. body composition

    Time frame: 52 weeks

  2. arterial pulse wave velocity

    Time frame: 52 weeks

Secondary outcomes

  1. nutritional and adequacy indices

    Time frame: 52 weeks

  2. peritoneal transport characteristics

    Time frame: 52 weeks

  3. residual renal function

    Time frame: 52 weeks

  4. peritonitis-free survival, actuarial and technique survival

    Time frame: 52 weeks

  5. hospitalization

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

The Effect of Neutral Peritoneal Dialysis Solution With Minimal Glucose-Degradation-Product on the Fluid Status and Body Composition - A Randomized Control Trial

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Aug 27, 2009
Registry last updated
Sep 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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