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Open Label Trial to Establish the Equivalence Between ANDY-Disc® and Ultrabag® in Patients on CAPD.

NCT00255619 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2006-10-26

No results posted yet for this study

Summary

Apart from haemodialysis, continuous ambulatory peritoneal dialysis (CAPD) is another effective therapy for end stage renal disease (ESRD). The Achilles heel of CAPD however is peritonitis, which is a major cause of morbidity and mortality in CAPD patients. Advances in connectology, such as the disconnect system, have resulted in reduced rate of peritonitis. The disconnect system which incorporated a Y-connection allow contamination occurring at the time of connection of the system to flush into the drainage bag thereby reducing the size of microorganism innoculum entering the peritoneal cavity. In recent years, the twin bag system where both the infusion and drainage bags are pre-attached to the Y tubing, has resulted in further reduction in peritonitis rate.

Two different twin bags systems are being introduced into the MOH hospitals. They are Baxter UltraBag® and Fresenius Andy·Disc®.

Even though both the systems are very similar, our own experience suggest that minor variation in the connectology could translate into marked differences in the peritonitis rate. In this multi centre, randomised controlled study, both the twin bag systems will be evaluated to establish their equivalence with respect to the incidence of peritonitis and technique failure.

Conditions

  • Chronic Renal Failure

Interventions

DEVICE

Baxter's UltraBag® and FMC Andy·Disc®

Sponsors & Collaborators

  • Fresenius Medical Care North America

    collaborator INDUSTRY

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • Ministry of Health, Malaysia

    lead OTHER_GOV

Principal Investigators

  • Zaki Morad, MRCP, FRCP · Ministry of Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-05-31
Completion
2004-05-31

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00255619 on ClinicalTrials.gov