Randomized Controlled Trial Comparing Residual Kidney Function in Patients Undergoing Three or Four Exchanges CAPD
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01637792|
Recruitment Status : Completed
First Posted : July 11, 2012
Last Update Posted : July 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|End Stage Renal Disease Anuria Peritonitis||Other: Three 2-liter exchanges daily CAPD Other: Four 2-liter exchanges daily CAPD||Phase 4|
- The primary end point for this study was changes in residual kidney function including GFR, daily urine volume (Uvol), and anuria-free survival. GFR and Uvol were evaluated within 1 week before CAPD initiation (the baseline), and then at month 1, 6, 12, 18 and 24. At the same time, body weight, blood pressure, daily net ultrafiltration, dialysis adequacy, peritoneal solute transport rate, and biochemical parameters etc. were assessed. Once an episode of peritonitis or other serious reversible intercurrent illness occurred, all the assessments were delayed one month after being cured. Anuria was termed by daily Uvol permanently less than 100 ml.
- The secondary end points included technique survival, patient survival and peritonitis. Technique failure was defined as switching to maintenance hemodialysis.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||139 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Trial Comparing Residual Kidney Function in Patients Undergoing Three or Four Exchanges CAPD|
|Study Start Date :||June 2004|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||August 2010|
Experimental: Three 2-liter exchanges group
A group of randomly assigned patients undergoing three 2-liter exchanges daily CAPD.
Other: Three 2-liter exchanges daily CAPD
CAPD regimen of three 2-liter daily exchanges
Other Name: small volume CAPD
Active Comparator: Four 2-liter exchanges group
A group of randomly assigned patients undergoing four 2-liter exchanges daily CAPD.
Other: Four 2-liter exchanges daily CAPD
CAPD regimen of four 2-liter daily exchagnes
Other Name: standard volume CAPD
- Residual kidney function including glomerular filtration rate (GFR), daily urine voume (Uvol), and anuria-free survival. [ Time Frame: Up to 24 months after CAPD initiation ]GFR was calculated by the mean of renal clearance of urea and creatinine from a 24-h urine collection. Anuria was termed as consistently Uvol < 100 ml/day for more than a month.
- Number of participants having technique failure refering to switching to maintenance hemodialyisis [ Time Frame: Up to 24 months after CAPD initiation. ]
- Number of participants died [ Time Frame: Up to 24 months after CAPD initiation ]
- Episodes of peritonitis [ Time Frame: Up to 24 months after CAPD initiation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01637792
|Renji Hospital, Shanghai Jiao Tong University school of medicine|
|Shanghai, Shanghai, China, 200127|
|Principal Investigator:||Wei Fang, MD, PhD||Renal Division, Renji Hospital, Shanghai Jiaotong University School of Medicine|