Rationale and design of the HEALTHY-CATH trial: A randomised controlled trial of Heparin versus EthAnol Lock THerapY for the prevention of catheter associated infecTion in haemodialysis patients

Broom, Jennifer, O'Shea, Stacey, Govindarajula, Sridevi, Playford, Geoffrey, Hawley, Carmel M., Isbel, Nicole M., Campbell, Scott, Mudge, David, Carpenter, Sally, Johnson, Barbara, Underwood, Neil and Johnson, David W. (2009) Rationale and design of the HEALTHY-CATH trial: A randomised controlled trial of Heparin versus EthAnol Lock THerapY for the prevention of catheter associated infecTion in haemodialysis patients. BMC Nephrology, 10 23: xxx-xxx. doi:10.1186/1471-2369-10-23


Author Broom, Jennifer
O'Shea, Stacey
Govindarajula, Sridevi
Playford, Geoffrey
Hawley, Carmel M.
Isbel, Nicole M.
Campbell, Scott
Mudge, David
Carpenter, Sally
Johnson, Barbara
Underwood, Neil
Johnson, David W.
Title Rationale and design of the HEALTHY-CATH trial: A randomised controlled trial of Heparin versus EthAnol Lock THerapY for the prevention of catheter associated infecTion in haemodialysis patients
Journal name BMC Nephrology   Check publisher's open access policy
ISSN 1471-2369
Publication date 2009-08-20
Year available 2009
Sub-type Article (original research)
DOI 10.1186/1471-2369-10-23
Open Access Status DOI
Volume 10
Issue 23
Start page xxx
End page xxx
Total pages 6
Editor Norton, Melissa
Place of publication UK
Publisher BioMed Central Ltd
Collection year 2010
Language eng
Subject C1
920199 Clinical Health (Organs, Diseases and Abnormal Conditions) not elsewhere classified
110312 Nephrology and Urology
Formatted abstract
Background

Catheter-related bacteraemias (CRBs) contribute significantly to morbidity, mortality and health care costs in dialysis populations. Despite international guidelines recommending avoidance of catheters for haemodialysis access, hospital admissions for CRBs have doubled in the last decade. The primary aim of the study is to determine whether weekly instillation of 70% ethanol prevents CRBs compared with standard heparin saline.

Methods/design

The study will follow a prospective, open-label, randomized controlled design. Inclusion criteria are adult patients with incident or prevalent tunneled intravenous dialysis catheters on three times weekly haemodialysis, with no current evidence of catheter infection and no personal, cultural or religious objection to ethanol use, who are on adequate contraception and are able to give informed consent. Patients will be randomized 1:1 to receive 3 mL of intravenous-grade 70% ethanol into each lumen of the catheter once a week and standard heparin locks for other dialysis days, or to receive heparin locks only. The primary outcome measure will be time to the first episode of CRB, which will be defined using standard objective criteria. Secondary outcomes will include adverse reactions, incidence of CRB caused by different pathogens, time to infection-related catheter removal, time to exit site infections and costs. Prospective power calculations indicate that the study will have 80% statistical power to detect a clinically significant increase in median infection-free survival from 200 days to 400 days if 56 patients are recruited into each arm.

Discussion

This investigator-initiated study has been designed to provide evidence to help nephrologists reduce the incidence of CRBs in haemodialysis patients with tunnelled intravenous catheters.
Keyword Tunneled intravenous dialysis catheters
Haemodialysis,
CRB
Q-Index Code C1
Q-Index Status Confirmed Code

Document type: Journal Article
Sub-type: Article (original research)
Collections: 2010 Higher Education Research Data Collection
School of Medicine Publications
 
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Created: Thu, 25 Mar 2010, 16:02:22 EST by Denise Wilson on behalf of Medicine - Princess Alexandra Hospital