Randomized Controlled Trial Comparing Residual Renal Function in Patients Undergoing Three or Four Exchanges CAPD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aiwu Lin, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01637792
First received: July 1, 2012
Last updated: July 8, 2012
Last verified: July 2012

July 1, 2012
July 8, 2012
June 2004
August 2010   (final data collection date for primary outcome measure)
  • The changes in residual renal function including urine volume and residual glomerular filtration rate. [ Time Frame: Month 1 and 24 after CAPD initiation ] [ Designated as safety issue: No ]
  • Number of participants developing to anuria (permanently daily urine volume less than 200ml) [ Time Frame: Up to 24 months after CAPD initiation ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01637792 on ClinicalTrials.gov Archive Site
  • Number of participants having technique failure including death and switching to maintenance hemodialyisis [ Time Frame: Up to 24 months after CAPD initiation. ] [ Designated as safety issue: Yes ]
  • Episodes of peritonitis [ Time Frame: Up to 24 months after CAPD initiation ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Randomized Controlled Trial Comparing Residual Renal Function in Patients Undergoing Three or Four Exchanges CAPD
Randomized Controlled Trial Comparing Residual Renal Function in Patients Undergoing Three or Four Exchanges CAPD

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 renal function, technique survival and peritonitis rate in incident Chinese peritoneal dialysis patients.

  1. The primary end point for this study was changes in RRF including 24-h urine volume and residual GFR. These were evaluated at month 1, which was defined as the baseline, and then at month 6, 12, 18 and 24. At the same time, body weight, blood pressure, daily net ultrafiltration, and dialysis adequacy 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 200 ml.
  2. The secondary end points included technique survival and peritonitis rate. Technique failure was defined as both death and switch to maintenance hemodialysis.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • End Stage Renal Disease
  • Anuria
  • Peritonitis
Other: Three 2-liter exchanges daily CAPD
CAPD regimen of three 2-liter daily exchanges
Other Name: small volume CAPD
  • Experimental: Three 2-liter exchanges group
    A group of randomly assigned patients undergoing three 2-liter exchanges daily CAPD.
    Intervention: Other: Three 2-liter exchanges daily CAPD
  • Active Comparator: Four 2-liter exchanges group
    A group of randomly assigned patients undergoing four 2-liter exchanges daily CAPD.
    Intervention: Other: Three 2-liter exchanges daily CAPD

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
131
August 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • incident peritoneal dialysis patients
  • age between 18 to 80 yrs

Exclusion Criteria:

  • have a history of maintenance hemodialysis or renal transplantation
  • daily urine volume less than 800 ml
  • in severe conditions
  • unable to give informed consent
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01637792
044119620, 07QA14040, 08DZ1900501
No
Aiwu Lin, Shanghai Jiao Tong University School of Medicine
Shanghai Jiao Tong University School of Medicine
Not Provided
Principal Investigator: Wei Fang, MD, PhD Renal Division, Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai Jiao Tong University School of Medicine
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP