Randomized Controlled Trial Comparing Residual Kidney 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 20, 2016
Last verified: July 2016
  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 kidney function, technique survival, patient survival, and peritonitis in incident Chinese peritoneal dialysis patients.

Condition Intervention Phase
End Stage Renal Disease
Anuria
Peritonitis
Other: Three 2-liter exchanges daily CAPD
Other: Four 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 Kidney Function in Patients Undergoing Three or Four Exchanges CAPD

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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of participants having technique failure refering to switching to maintenance hemodialyisis [ Time Frame: Up to 24 months after CAPD initiation. ] [ Designated as safety issue: Yes ]
  • Number of participants died [ 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: 139
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: Four 2-liter exchanges daily CAPD
CAPD regimen of four 2-liter daily exchagnes
Other Name: standard volume CAPD

Detailed Description:
  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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • incident CAPD patients aged 18 to 80 years
  • GFR ≥ 2 ml/min and Uvol ≥ 500 ml/day

Exclusion Criteria:

  • have a history of maintenance hemodialysis or renal transplantation
  • anticipated life expectancy less than 6 months
  • with active malignancy, acute infection, significant heart failure or in other severe conditions
  • unable to give informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 20, 2016
Health Authority: China: Science and Technology Commission of Shanghai Municipality
Individual Participant Data  
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Kidney Failure, Chronic
Peritonitis
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Intraabdominal Infections
Infection
Peritoneal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 28, 2016