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1. Ethanol lock therapy (E-Lock) in the prevention of catheter-related bloodstream infections (CR-BSI) after major heart surgery (MHS): a randomized clinical trial.

Author

María Jesús Pérez-Granda, José María Barrio, Patricia Muñoz, Javier Hortal, Cristina Rincón, Pablo Martin Rabadán, Maria Sagrario Pernia, and Emilio Bouza

Subjects
Medicine, Science
Abstract

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.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.We do not recommend prophylaxis of CR-BSI with ethanol-lock on a routine basis in patients undergoing Major Heart Surgery.Clinical Trials.gov NCT01229592.

Published
2014
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2. Ethanol lock therapy (E-Lock) in the prevention of catheter-related bloodstream infections (CR-BSI) after major heart surgery (MHS): a randomized clinical trial

Author

Javier Hortal, Cristina Rincón, Maria Sagrario Pernia, Emilio Bouza, José María Barrio, Pablo Martín Rabadán, María Jesús Pérez-Granda, and Patricia Muñoz

Subjects
Male, Critical Care and Emergency Medicine, Epidemiology, Cardiovascular Procedures, Treatment outcome, Antibiotics, lcsh:Medicine, law.invention, Catheters, Indwelling, Randomized controlled trial, law, Medicine and Health Sciences, lcsh:Science, education.field_of_study, Multidisciplinary, Middle Aged, Cardiac surgery, Catheter, Treatment Outcome, Infectious Diseases, Research Design, Female, Research Article, medicine.medical_specialty, Catheterization, Central Venous, Infectious Disease Control, medicine.drug_class, Clinical Research Design, Population, Cardiology, Surgical and Invasive Medical Procedures, Research and Analysis Methods, Infectious Disease Epidemiology, medicine, Humans, Ethanol lock, Clinical Trials, Cardiac Surgical Procedures, Adverse effect, education, Aged, Treatment Guidelines, Health Care Policy, Ethanol, business.industry, lcsh:R, bacterial infections and mycoses, Surgery, Health Care, Catheter-Related Infections, lcsh:Q, Clinical Medicine, business, human activities
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. Methods and Findings 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. Trial Registration Clinical Trials.gov NCT01229592

Published
2013

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