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.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry Number: ACTRN12609000493246.
authors.affiliation: Department of Nephrology, University of Queensland at Princess Alexandra Hospital, Brisbane, Australia. jennifer_broom@health.qld.gov.au
authors.forename: Jennifer K
authors.initials: JK
authors.lastname: Broom
authors.forename: Stacey
authors.initials: S
authors.lastname: O'Shea
authors.forename: Sridevi
authors.initials: S
authors.lastname: Govindarajulu
authors.forename: E Geoffrey
authors.initials: EG
authors.lastname: Playford
authors.forename: Carmel M
authors.initials: CM
authors.lastname: Hawley
authors.forename: Nicole M
authors.initials: NM
authors.lastname: Isbel
authors.forename: Scott B
authors.initials: SB
authors.lastname: Campbell
authors.forename: David W
authors.initials: DW
authors.lastname: Mudge
authors.forename: Sally
authors.initials: S
authors.lastname: Carpenter
authors.forename: Barbara C
authors.initials: BC
authors.lastname: Johnson
authors.forename: Neil P
authors.initials: NP
authors.lastname: Underwood
authors.forename: David W
authors.initials: DW
authors.lastname: Johnson
mesh_terms: D000925:Anticoagulants / Q000008:administration & dosage*; D055499:Catheter-Related Infections / Q000209:etiology* / Q000517:prevention & control*; D002408:Catheters, Indwelling / Q000009:adverse effects*; D000431:Ethanol / Q000008:administration & dosage*; D006493:Heparin / Q000008:administration & dosage*; D006801:Humans; D007676:Kidney Failure, Chronic / Q000150:complications / Q000534:rehabilitation*; D006435:Renal Dialysis / Q000009:adverse effects*; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D000431:Ethanol; D006493:Heparin
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