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
  Purpose

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.


Condition Intervention Phase
End Stage Renal Disease
Anuria
Peritonitis
Other: Three 2-liter exchanges daily CAPD
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing Residual Renal Function in Patients Undergoing Three or Four Exchanges CAPD

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 131
Study Start Date: June 2004
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Three 2-liter exchanges daily CAPD
CAPD regimen of three 2-liter daily exchanges
Other Name: small volume CAPD

Detailed Description:
  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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01637792

Locations
China, Shanghai
Renji Hospital, Shanghai Jiao Tong University school of medicine
Shanghai, Shanghai, China, 200127
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Wei Fang, MD, PhD Renal Division, Renji Hospital, Shanghai Jiaotong University School of Medicine
  More Information

Publications:
Responsible Party: Aiwu Lin, MD, PhD, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01637792     History of Changes
Other Study ID Numbers: 044119620, 07QA14040, 08DZ1900501
Study First Received: July 1, 2012
Last Updated: July 8, 2012
Health Authority: China: Science and Technology Commission of Shanghai Municipality

Keywords provided by Shanghai Jiao Tong University School of Medicine:
peritoneal dialysis
dose
residual renal function
technique survival
peritonitis

Additional relevant MeSH terms:
Anuria
Kidney Diseases
Kidney Failure, Chronic
Peritonitis
Urologic Diseases
Urination Disorders
Renal Insufficiency, Chronic
Renal Insufficiency
Peritoneal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014