title: Ethanol lock therapy (E-Lock) in the prevention of catheter-related bloodstream infections (CR-BSI) after major heart surgery (MHS): a randomized clinical trial.
abstract: BACKGROUND
  Lock-therapy with antimicrobials has been used for the treatment and prevention of catheter-related bloodstream infections (CR-BSI). Experiences with Ethanol-Locks (E-locks) have included therapeutic interventions with variable results. Patients undergoing Major Heart Surgery (MHS) are a high-risk population for CR-BSI.The aim of this study was to assess the efficacy and tolerance to E-Locks in the prevention of CR-BSI of patients undergoing MHS.
  
  
  RESULTS
  This is an academic, prospective, randomized, non-blinded and controlled clinical trial assessing the incidence of CR-BSI of patients with E-locks (E-lock) and the tolerance to the procedure in comparison with patients receiving conventional catheter-care (CCC). Patients undergoing MHS with intravascular catheters for more than 48 hours were randomly assigned into treatment or control group by a computer-generated list of randomly assigned numbers. In the treatment group, all their catheter lumens were locked with an ethanol solution at 70% for two hours, every three days (E-Locks). The control group received conventional catheter-care (CCC). Overall, 200 patients with 323 catheters were included in the study, which was stopped after 10 months due to adverse events. Of them, 179 catheters (113 patients) had E-Locks and 144 catheters (87 patients) were CCC. Euroscore Surgical Risk in both groups was 4.04 vs 4.07 p = 0.94 respectively. The results for the E-Locks and CCC were as follows: Incidence of CR-BSI/1000 days of exposure 2.1 vs 5.2 (p = 0.33), catheter tip colonization 14 (7.8%) vs 6 (4.2%) patients (p = 0.17), median length of hospital stay, 15 vs 16 days (p = 0.77). Seven patients (6.19%), all in the ethanol branch, had to discontinue the trial due to intolerance or adverse events.
  
  
  CONCLUSIONS
  We do not recommend prophylaxis of CR-BSI with ethanol-lock on a routine basis in patients undergoing Major Heart Surgery.
  
  
  BACKGROUND
  Clinical Trials.gov NCT01229592.
authors.affiliation: Department of Anesthesiology, School of Medicine, Universidad Complutense, Madrid, Spain; Instituto de Investigación Biomédica Gregorio Marañón, Madrid, Spain; CIBER Enfermedades Respiratorias-CIBERES (CB06/06/0058), Madrid, Spain.
authors.forename: María Jesús
authors.initials: MJ
authors.lastname: Pérez-Granda
authors.affiliation: Department of Anesthesiology, School of Medicine, Universidad Complutense, Madrid, Spain; Instituto de Investigación Biomédica Gregorio Marañón, Madrid, Spain; CIBER Enfermedades Respiratorias-CIBERES (CB06/06/0058), Madrid, Spain.
authors.forename: José María
authors.initials: JM
authors.lastname: Barrio
authors.affiliation: Department of Clinical Microbiology and Infectious Diseases, School of Medicine, Universidad Complutense, Madrid, Spain; Medicine Department, School of Medicine, Universidad Complutense, Madrid, Spain; Instituto de Investigación Biomédica Gregorio Marañón, Madrid, Spain; CIBER Enfermedades Respiratorias-CIBERES (CB06/06/0058), Madrid, Spain.
authors.forename: Patricia
authors.initials: P
authors.lastname: Muñoz
authors.affiliation: Department of Anesthesiology, School of Medicine, Universidad Complutense, Madrid, Spain; Instituto de Investigación Biomédica Gregorio Marañón, Madrid, Spain; CIBER Enfermedades Respiratorias-CIBERES (CB06/06/0058), Madrid, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Hortal
authors.affiliation: Department of Anesthesiology, School of Medicine, Universidad Complutense, Madrid, Spain.
authors.forename: Cristina
authors.initials: C
authors.lastname: Rincón
authors.affiliation: Department of Clinical Microbiology and Infectious Diseases, School of Medicine, Universidad Complutense, Madrid, Spain; Medicine Department, School of Medicine, Universidad Complutense, Madrid, Spain; Instituto de Investigación Biomédica Gregorio Marañón, Madrid, Spain; CIBER Enfermedades Respiratorias-CIBERES (CB06/06/0058), Madrid, Spain.
authors.forename: Pablo Martin
authors.initials: PM
authors.lastname: Rabadán
authors.affiliation: Department of Pharmacy, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
authors.forename: Maria Sagrario
authors.initials: MS
authors.lastname: Pernia
authors.affiliation: Department of Clinical Microbiology and Infectious Diseases, School of Medicine, Universidad Complutense, Madrid, Spain; Medicine Department, School of Medicine, Universidad Complutense, Madrid, Spain; Instituto de Investigación Biomédica Gregorio Marañón, Madrid, Spain; CIBER Enfermedades Respiratorias-CIBERES (CB06/06/0058), Madrid, Spain.
authors.forename: Emilio
authors.initials: E
authors.lastname: Bouza
mesh_terms: D000368:Aged; D006348:Cardiac Surgical Procedures / Q000009:adverse effects* / Q000379:methods; D055499:Catheter-Related Infections / Q000209:etiology* / Q000382:microbiology / Q000517:prevention & control*; D002405:Catheterization, Central Venous / Q000009:adverse effects; D002408:Catheters, Indwelling / Q000009:adverse effects*; D000431:Ethanol / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D000431:Ethanol