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

BackgroundLock-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 FindingsThis 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.ConclusionsWe do not recommend prophylaxis of CR-BSI with ethanol-lock on a routine basis in patients undergoing Major Heart Surgery.Trial RegistrationClinical Trials.gov NCT01229592

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Ethanol combined with heparin as a locking solution for the prevention of catheter related blood stream infections in hemodialysis patients: A prospective randomized study

“…The study failed to demonstrate any benefit for the ethanol group regarding the frequency of CRBSI. 23 The incidence of CRBSI/1000 days of exposure was 2.1 for the ethanol locks vs. 5.2 for the conventional catheter care group (P 5 0.33), and although the number of CRBSI was reduced by 58% in patients receiving ethanol the differences did not reach statistical significance, probably due to the early stop of the study and the consequent low power. 25 The second study is a prospective, randomized, controlled trial that assessed the incidence of CRBSI in 200 patients with 323 NTCs undergoing Major Heart Surgery that were randomized to receive an ethanol solution at 70% for 2 hours, every 3 days, or conventional cathetercare.…”

“…25 The second study is a prospective, randomized, controlled trial that assessed the incidence of CRBSI in 200 patients with 323 NTCs undergoing Major Heart Surgery that were randomized to receive an ethanol solution at 70% for 2 hours, every 3 days, or conventional cathetercare. 23 The incidence of CRBSI/1000 days of exposure was 2.1 for the ethanol locks vs. 5.2 for the conventional catheter care group (P 5 0.33), and although the number of CRBSI was reduced by 58% in patients receiving ethanol the differences did not reach statistical significance, probably due to the early stop of the study and the consequent low power.…”

“…20,21 The administration of ethanol lock in NTCs for the prevention of CRBSI was recently assessed in two studies one in critically ill intensive care unit (ICU) patients under renal replacement therapy or plasma exchange, 22 and one in patients undergoing major heart surgery. 23 In order to evaluate the safety and efficacy of an ethanol lock solution in preventing CRBSI in HD patients with NTCs, we conducted a prospective randomized study comparing ethanol 70% 1 unfractionated heparin 2.000 U/mL (group A) with unfractionated heparin 2.000 U/mL (group B) as a single lock.…”