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
Highlights
Patients undergoing Major Heart Surgery (MHS) are at a high risk of developing Catheter-Related Bloodstream Infections (CRBSI) leading to a subsequent increase in morbidity and mortality [1,2,3,4].Efforts developed to eliminate catheter-related bloodstream infections (CR-BSI) in patients hospitalized in Intensive Care Units (ICU’s) have mainly concentrated on mixed ICUs and not on patients following MHS, who usually require more catheters during more prolonged periods of time [5,6,7]
Efforts developed to eliminate CR-BSI in patients hospitalized in Intensive Care Units (ICU’s) have mainly concentrated on mixed ICUs and not on patients following MHS, who usually require more catheters during more prolonged periods of time [5,6,7]
The programs addressed to eliminate CR-BSI episodes are mainly based on educational policies and on non-pharmacological measures and, effective, these programs fail to lead to the disappearance of CR-BSI in most units and are often difficult to maintain for prolonged periods of time [8,9]
Summary
Patients undergoing Major Heart Surgery (MHS) are at a high risk of developing Catheter-Related Bloodstream Infections (CRBSI) leading to a subsequent increase in morbidity and mortality [1,2,3,4].Efforts developed to eliminate CR-BSI in patients hospitalized in Intensive Care Units (ICU’s) have mainly concentrated on mixed ICUs and not on patients following MHS, who usually require more catheters during more prolonged periods of time [5,6,7]. Patients undergoing Major Heart Surgery (MHS) are at a high risk of developing Catheter-Related Bloodstream Infections (CRBSI) leading to a subsequent increase in morbidity and mortality [1,2,3,4]. Ethanol locks (E-locks) were greeted as a potential non-antibiotic alternative for the rescue of infected long-term catheters that were very difficult to substitute in different and disparate populations [14,15,16,17,18]. 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
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