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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01637792
First Posted: July 11, 2012
Last Update Posted: July 22, 2016
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.
Information provided by (Responsible Party):
Aiwu Lin, Shanghai Jiao Tong University School of Medicine
  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
Intervention Model: Parallel Assignment
Masking: None (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 Aiwu Lin, 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 ]
    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. ]
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


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 ( Other Grant/Funding Number: Science and Technology Commission of Shanghai Municipality )
08DZ1900501 ( Other Grant/Funding Number: Science and Technology Commission of Shanghai Municipality )
First Submitted: July 1, 2012
First Posted: July 11, 2012
Last Update Posted: July 22, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Aiwu Lin, 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