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

Shanghai Jiao Tong University School of Medicine139 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

139

Conditions

End Stage Renal Disease Anuria Peritonitis

Interventions

Three 2-liter exchanges daily CAPDOTHER

CAPD regimen of three 2-liter daily exchanges

Four 2-liter exchanges daily CAPDOTHER

CAPD regimen of four 2-liter daily exchagnes

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Renji Hospital, Shanghai Jiao Tong University school of medicine

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

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.

Time frame: Up to 24 months after CAPD initiation

Secondary Outcomes

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

Data from ClinicalTrials.gov

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