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Evaluation of a new disconnect CAPD system

Evaluation of a new disconnect CAPD system

CAPD1 Trial

General Information
Research Type
Interventional
Description
This is a multi-centre parallel group randomised controlled trial designed to demonstrate the equivalence of Carex® (B.Braun) with the standard connection system (Ultra® (Baxter)). 474 prevalent CAPD patients from nine participating sites who meet inclusion/exclusion criteria will be enrolled into the trial. Subjects will be randomly allocated to Carex® or Ultra® connection system in a ratio of 1:1. The primary end-point is peritonitis rate, and secondary end-points are technique failure and technical problems with connection system.
Study Information
RMK Priority Area
Research Level
Research Keyword
ESRD, CAPD, dialysis, therapeutic equivalence
Inclusion & Exclusion Criteria
Inclusion Criteria
Inclusion criteria :
1. Patients under MOH dialysis programme currently on CAPD or DAPD (daytime ambulatory peritoneal dialysis)
2. Patient or parental consent


Exclusion criteria :
1. Children age less than 12 years
2. Patients with terminal illness and life expectancy of less than six months
3. Patients expected to change modality of renal replacement therapy over next three months
4. Use of automated cycler assistance
Exclusion Criteria
Inclusion criteria :
1. Patients under MOH dialysis programme currently on CAPD or DAPD (daytime ambulatory peritoneal dialysis)
2. Patient or parental consent


Exclusion criteria :
1. Children age less than 12 years
2. Patients with terminal illness and life expectancy of less than six months
3. Patients expected to change modality of renal replacement therapy over next three months
4. Use of automated cycler assistance
Study Timeline
Expected / Actual Date Study Starts - First Enrolment of subject / Collecting data
May, 01 1999
Expected / Actual Date Study Completed
Jan, 15 2001
Expected / Actual Duration of Study Enrollment / Data Collection
89 weeks