title: An ethanol/sodium citrate locking solution compared to heparin to prevent hemodialysis catheter-related infections: a randomized pilot study.
abstract: OBJECTIVE
  The objective of this study was to compare the initial safety and efficacy of a novel 30% ethanol/4% sodium citrate catheter-locking solution to heparin in a hemodialysis population.
  
  
  METHODS
  This was a prospective, randomized, pilot study of 40 hemodialysis patients randomized to a 30% ethanol/4% sodium citrate or heparin 1000 units/mL locking solution. The primary outcome was identification of any serious adverse events over the study duration. Secondary outcomes included the rate per 1000 catheter days for catheter-related bloodstream infections (CRBSI), alteplase use, catheter dysfunction, and catheter removal.
  
  
  RESULTS
  Three serious adverse events were reported as possibly related to the catheter solutions. Only one CRBSI was observed during the study in the heparin arm. The rate of alteplase use was 1.5/1000 catheter days in the heparin arm compared to 2.8/1000 catheter days in the ethanol/citrate arm (rate ratio = 1.85, 90% CI 0.48, 7.07, p value = 0.45), while the rate of catheter dysfunction was 6.8/1000 catheter days in the heparin arm compared to 1.9/1000 catheter days in the ethanol citrate arm (rate ratio = 0.27, 90% CI 0.10, 0.74, p value = 0.04). Catheter survival to first catheter outcome was longer in the ethanol/citrate group compared to heparin and there were no catheter removals due to bacteremia or thrombosis.
  
  
  CONCLUSIONS
  The ethanol/sodium citrate locking solution was safely used in this study. It appears to prevent CRBSI and may improve catheter survival compared to heparin.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT01394458.
authors.affiliation: Faculty of Health Sciences, College of Pharmacy, University of Manitoba, Winnipeg, Manitoba - Canada.
authors.forename: Lavern M
authors.initials: LM
authors.lastname: Vercaigne
authors.affiliation: Faculty of Health Sciences, College of Medicine, Department of Internal Medicine, Section of Nephrology, University of Manitoba, Winnipeg, Manitoba - Canada.
authors.forename: Don R
authors.initials: DR
authors.lastname: Allan
authors.affiliation: Faculty of Health Sciences, College of Medicine, Department of Internal Medicine, Section of Nephrology, University of Manitoba, Winnipeg, Manitoba - Canada.
authors.forename: Sean W
authors.initials: SW
authors.lastname: Armstrong
authors.affiliation: Faculty of Health Sciences, College of Medicine, Department of Internal Medicine, Section of Nephrology, University of Manitoba, Winnipeg, Manitoba - Canada.
authors.forename: James M
authors.initials: JM
authors.lastname: Zacharias
authors.affiliation: Faculty of Health Sciences, College of Medicine, Department of Internal Medicine, Section of Nephrology, University of Manitoba, Winnipeg, Manitoba - Canada.
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Miller
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D061807:Catheter Obstruction / Q000209:etiology; D002405:Catheterization, Central Venous / Q000009:adverse effects / Q000295:instrumentation*; D002408:Catheters, Indwelling; D062905:Central Venous Catheters; D002951:Citrates / Q000008:administration & dosage* / Q000009:adverse effects; D004867:Equipment Design; D000431:Ethanol / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006493:Heparin / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008350:Manitoba; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D006435:Renal Dialysis; D012307:Risk Factors; D000077559:Sodium Citrate; D013927:Thrombosis / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000925:Anticoagulants; D002951:Citrates; D000077559:Sodium Citrate; D000431:Ethanol; D006493:Heparin