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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01637792
Enrollment
139
Registered
2012-07-11
Start date
2004-06-30
Completion date
2010-08-31
Last updated
2016-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anuria, End Stage Renal Disease, Peritonitis

Keywords

peritoneal dialysis, dose, residual kidney function, technique survival, patient survival, peritonitis

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.

Interventions

OTHERThree 2-liter exchanges daily CAPD

CAPD regimen of three 2-liter daily exchanges

OTHERFour 2-liter exchanges daily CAPD

CAPD regimen of four 2-liter daily exchagnes

Sponsors

Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Residual kidney function including glomerular filtration rate (GFR), daily urine voume (Uvol), and anuria-free survival.Up to 24 months after CAPD initiationGFR 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

MeasureTime frame
Number of participants having technique failure refering to switching to maintenance hemodialyisisUp to 24 months after CAPD initiation.
Number of participants diedUp to 24 months after CAPD initiation
Episodes of peritonitisUp to 24 months after CAPD initiation

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026