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

History of Changes

Tracking Information

First Received Date ^ICMJE

July 1, 2012

Last Updated Date

July 8, 2012

Start Date ^ICMJE

June 2004

Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01637792 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Randomized Controlled Trial Comparing Residual Renal 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 renal function, technique survival and peritonitis rate in incident Chinese peritoneal dialysis patients.

Detailed Description

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.
The secondary end points included technique survival and peritonitis rate. Technique failure was defined as both death and switch to maintenance hemodialysis.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

End Stage Renal Disease
Anuria
Peritonitis

Intervention ^ICMJE

Other: Three 2-liter exchanges daily CAPD

CAPD regimen of three 2-liter daily exchanges

Other Name: small volume CAPD

Study Arm (s)

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

131

Completion Date

August 2010

Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01637792

Other Study ID Numbers ^ICMJE

044119620, 07QA14040, 08DZ1900501

Has Data Monitoring Committee

Responsible Party

Aiwu Lin, Shanghai Jiao Tong University School of Medicine

Study Sponsor ^ICMJE

Shanghai Jiao Tong University School of Medicine

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Wei Fang, MD, PhD

Renal Division, Renji Hospital, Shanghai Jiaotong University School of Medicine

Information Provided By

Shanghai Jiao Tong University School of Medicine

Verification Date

July 2012

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

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