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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2010-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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End Stage Renal Disease Anuria Peritonitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Three 2-liter exchanges group

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

Group Type EXPERIMENTAL

Three 2-liter exchanges daily CAPD

Intervention Type OTHER

CAPD regimen of three 2-liter daily exchanges

Four 2-liter exchanges group

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

Group Type ACTIVE_COMPARATOR

Four 2-liter exchanges daily CAPD

Intervention Type OTHER

CAPD regimen of four 2-liter daily exchagnes

Interventions

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Three 2-liter exchanges daily CAPD

CAPD regimen of three 2-liter daily exchanges

Intervention Type OTHER

Four 2-liter exchanges daily CAPD

CAPD regimen of four 2-liter daily exchagnes

Intervention Type OTHER

Other Intervention Names

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small volume CAPD standard volume CAPD

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No