Clinical Trial: Randomized Controlled Trial Comparing Residual Kidney Function in Patients Undergoing Three or Four Exchanges CAPD

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Controlled Trial Comparing Residual Kidney Function in Patients Undergoing Three or Four Exchanges CAPD

Brief Summary: The purpose of this study was to explore the impacts of different continuous ambulatory peritoneal dialysis (CAPD) dosage (three 2-Liter exchanges CAPD vs. four 2-Liter exchanges CAPD) on residual kidney function, technique survival, patient survival, and peritonitis in incident Chinese peritoneal dialysis patients.

Detailed Summary:

  1. 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.
  2. The secondary end points included technique survival, patient survival and peritonitis. Technique failure was defined as switching to maintenance hemodialysis.

Sponsor: Shanghai Jiao Tong University School of Medicine

Current Primary Outcome: 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.


Original Primary Outcome:

  • The changes in residual renal function including urine volume and residual glomerular filtration rate. [ Time Frame: Month 1 and 24 after CAPD initiation ]
  • Number of participants developing to anuria (permanently daily urine volume less than 200ml) [ Time Frame: Up to 24 months after CAPD initiation ]


Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • Number of participants having technique failure including death and switching to maintenance hemodialyisis [ Time Frame: Up to 24 months after CAPD initiation. ]
  • Episodes of peritonitis [ Time Frame: Up to 24 months after CAPD initiation ]


Information By: Shanghai Jiao Tong University School of Medicine

Dates:
Date Received: July 1, 2012
Date Started: June 2004
Date Completion:
Last Updated: July 20, 2016
Last Verified: July 2016