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

Study Overview
=================
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.

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

Conditions
-----------------
End Stage Renal Disease, Anuria, Peritonitis

Intervention / Treatment
-----------------
* Other: Three 2-liter exchanges daily CAPD
* Other: Four 2-liter exchanges daily CAPD


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Three 2-liter exchanges group<br>A group of randomly assigned patients undergoing three 2-liter exchanges daily CAPD. | Other: Three 2-liter exchanges daily CAPD<br>* CAPD regimen of three 2-liter daily exchanges<br>* Other names: small volume CAPD;|
| Active Comparator: Four 2-liter exchanges group<br>A group of randomly assigned patients undergoing four 2-liter exchanges daily CAPD. | Other: Four 2-liter exchanges daily CAPD<br>* CAPD regimen of four 2-liter daily exchagnes<br>* Other names: standard volume CAPD;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 24 months after CAPD initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Episodes of peritonitis |  | Up to 24 months after CAPD initiation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
peritoneal dialysis, dose, residual kidney function, technique survival, patient survival, peritonitis