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

Primary Purpose

End Stage Renal Disease, Anuria, Peritonitis

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Three 2-liter exchanges daily CAPD
Four 2-liter exchanges daily CAPD
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring peritoneal dialysis, dose, residual kidney function, technique survival, patient survival, peritonitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Renji Hospital, Shanghai Jiao Tong University school of medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Three 2-liter exchanges group

Four 2-liter exchanges group

Arm Description

A group of randomly assigned patients undergoing three 2-liter exchanges daily CAPD.

A group of randomly assigned patients undergoing four 2-liter exchanges daily CAPD.

Outcomes

Primary Outcome Measures

Residual kidney function including glomerular filtration rate (GFR), daily urine voume (Uvol), and anuria-free survival.
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
Number of participants died
Episodes of peritonitis

Full Information

First Posted
July 1, 2012
Last Updated
July 20, 2016
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01637792
Brief Title
Randomized Controlled Trial Comparing Residual Kidney Function in Patients Undergoing Three or Four Exchanges CAPD
Official Title
Randomized Controlled Trial Comparing Residual Kidney Function in Patients Undergoing Three or Four Exchanges CAPD
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 kidney function, technique survival, patient survival, and peritonitis in incident Chinese peritoneal dialysis patients.
Detailed Description
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. The secondary end points included technique survival, patient survival and peritonitis. Technique failure was defined as switching to maintenance hemodialysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Anuria, Peritonitis
Keywords
peritoneal dialysis, dose, residual kidney function, technique survival, patient survival, peritonitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Three 2-liter exchanges group
Arm Type
Experimental
Arm Description
A group of randomly assigned patients undergoing three 2-liter exchanges daily CAPD.
Arm Title
Four 2-liter exchanges group
Arm Type
Active Comparator
Arm Description
A group of randomly assigned patients undergoing four 2-liter exchanges daily CAPD.
Intervention Type
Other
Intervention Name(s)
Three 2-liter exchanges daily CAPD
Other Intervention Name(s)
small volume CAPD
Intervention Description
CAPD regimen of three 2-liter daily exchanges
Intervention Type
Other
Intervention Name(s)
Four 2-liter exchanges daily CAPD
Other Intervention Name(s)
standard volume CAPD
Intervention Description
CAPD regimen of four 2-liter daily exchagnes
Primary Outcome Measure Information:
Title
Residual kidney function including glomerular filtration rate (GFR), daily urine voume (Uvol), and anuria-free survival.
Description
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.
Time Frame
Up to 24 months after CAPD initiation
Secondary Outcome Measure Information:
Title
Number of participants having technique failure refering to switching to maintenance hemodialyisis
Time Frame
Up to 24 months after CAPD initiation.
Title
Number of participants died
Time Frame
Up to 24 months after CAPD initiation
Title
Episodes of peritonitis
Time Frame
Up to 24 months after CAPD initiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Fang, MD, PhD
Organizational Affiliation
Renal Division, Renji Hospital, Shanghai Jiaotong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renji Hospital, Shanghai Jiao Tong University school of medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
8728185
Citation
Lo WK, Jiang Y, Cheng SW, Cheng IK. Survival of CAPD patients in a center using three two-liter exchanges as standard regime. Perit Dial Int. 1996;16 Suppl 1:S163-6.
Results Reference
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PubMed Identifier
9323505
Citation
Szeto CC, Lai KN, Yu AW, Leung CB, Ho KK, Mak TW, Li PK, Lam CW. Dialysis adequacy of Asian patients receiving small volume continuous ambulatory peritoneal dialysis. Int J Artif Organs. 1997 Aug;20(8):428-35.
Results Reference
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PubMed Identifier
18790809
Citation
Fang W, Qian J, Lin A, Rowaie F, Ni Z, Yao Q, Bargman JM, Oreopoulos DG. Comparison of peritoneal dialysis practice patterns and outcomes between a Canadian and a Chinese centre. Nephrol Dial Transplant. 2008 Dec;23(12):4021-8. doi: 10.1093/ndt/gfn372. Epub 2008 Sep 12.
Results Reference
background
PubMed Identifier
11007375
Citation
Singhal MK, Bhaskaran S, Vidgen E, Bargman JM, Vas SI, Oreopoulos DG. Rate of decline of residual renal function in patients on continuous peritoneal dialysis and factors affecting it. Perit Dial Int. 2000 Jul-Aug;20(4):429-38.
Results Reference
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Randomized Controlled Trial Comparing Residual Kidney Function in Patients Undergoing Three or Four Exchanges CAPD

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