Clinical trial NCT00966615: The Effect of Neutral Peritoneal Dialysis (PD) Solution With Minimal Glucose-Degradation-Product (GDP) on Fluid Status and Body Composition
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Failure
ESRD
Cardiovascular Disease
Keywords: malnutrition
fluid status
survival
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2009-08-27
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: body composition
timeFrame: 52 weeks
measure: arterial pulse wave velocity
timeFrame: 52 weeks
Secondary outcomes:
measure: nutritional and adequacy indices
timeFrame: 52 weeks
measure: peritoneal transport characteristics
timeFrame: 52 weeks
measure: residual renal function
timeFrame: 52 weeks
measure: peritonitis-free survival, actuarial and technique survival
timeFrame: 52 weeks
measure: hospitalization
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Sha Tin
country: Hong Kong
facility: Department of Medicine & Therapeutics, Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Cheuk Chun Szeto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Prince of Wales Hospital, Shatin, Hong Kong
name: Philip KT Li, MD
role: STUDY_DIRECTOR
References:
citation: 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.