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

Phase 4

Completed

• Conditions: Peritonitis; End Stage Renal Disease; Anuria
• Interventions: Other: Three 2-liter exchanges daily CAPD; Other: Four 2-liter exchanges daily CAPD

• Registration Number: NCT01637792
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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

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.

Study Timeline

• Study Start: 2004-06
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Study First Submitted: 2012-07-01
• Study First Submitted QC: 2012-07-08
• Study First Posted: 2012-07-11
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-20
• Last Update Posted: 2016-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Three 2-liter exchanges group	Three 2-liter exchanges daily CAPD	A group of randomly assigned patients undergoing three 2-liter exchanges daily CAPD.
Four 2-liter exchanges group	Four 2-liter exchanges daily CAPD	A group of randomly assigned patients undergoing four 2-liter exchanges daily CAPD.

Primary Outcome Measures

Name	Time	Method
Residual kidney function including glomerular filtration rate (GFR), daily urine voume (Uvol), and anuria-free survival.	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

Name	Time	Method
Episodes of peritonitis	Up to 24 months after CAPD initiation
Number of participants having technique failure refering to switching to maintenance hemodialyisis	Up to 24 months after CAPD initiation.
Number of participants died	Up to 24 months after CAPD initiation

Trial Locations

Locations (1)

Renji Hospital, Shanghai Jiao Tong University school of medicine; 🇨🇳 Shanghai, Shanghai, China