NCT00966615|CompletedPhase 4
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Sponsor study identifier
interventional
68
1 country
1
Study Start
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2014
Actual (reported)Study Completion
September 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2014
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 26, 2009
Actual (reported)August 27, 2009
Actual (reported)September 2010
Date type not reportedThis date has not been verified as actual or estimated.
September 2014
Actual (reported)September 2014
Actual (reported)body composition
52 weeks
arterial pulse wave velocity
52 weeks
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
peritoneal dialysis with neutral peritoneal dialysis solution with minimal glucose-degradation-product
conventional PD solution
2-L exchange; three times a day
2-L exchange; three times a day
Department of Medicine & Therapeutics, Prince of Wales Hospital
Shatin, Hong Kong
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.
Cheuk Chun Szeto, MD
Chinese University of Hong Kong
Philip KT Li, MD
Prince of Wales Hospital, Shatin, Hong Kong
68 participants (actual enrollment reported by the registry).
First Submitted
August 26, 2009
First Posted
August 27, 2009
Study Start
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
Pulse Wave Velocity, Pulse Wave Morphology and Blocking of the Reninangiotensin System in Patients With Chronic Kidney Disease
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Primary Completion
September 2014
Actual (reported)Study Completion
September 2014
Actual (reported)Last Updated
September 8, 2014
Record last verified: 2014-09
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Source: ClinicalTrials.gov.
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