Reduction of catheter associated bloodstream infections in paediatric oncology patients using ethanol locks; a randomized controlled trial

Objectives: The prevention of central venous catheter‐ (CVC‐) associated bloodstream infection (CABSI) in pediatric oncology patients is essential. Ethanol locks can eliminate biofilm embedded pathogens and have no known microbial resistance. Up to date no randomized controlled trial in pediatric oncology has been performed on the efficacy of ethanol locks to reduce CABSI. This study's objective was to determine whether 70% ethanol locks can cause a 50% reduction in CABSI in pediatric oncology patients. Methods: We conducted a randomized, double blind, multicenter trial in pediatric oncology patients (1‐18 years) with newly inserted CVCs. Patients were randomly assigned to receive two hour ethanol locks (3 ml 70%) or heparin locks (3 ml 100 IU/ml), maximum frequency once weekly. Primary outcomes were CABSI, CVC removal or death due to CABSI. Results:We included 307 patients, 153 were allocated to ethanol and 154 to heparin locks. In the ethanol group 16/153 (10%) patients were diagnosed with CABSI versus 29/154 (19%) in the heparin group; incidence was 0.77/1000 and 1.46/1000 catheter days respectively (p=0.04), resulting in a number‐needed‐to‐treat of 12 patients. Particularly Gram‐positive CABSIs (ethanol, N=8; heparin, N=21; p=0.01) were reduced. Less CVCs were removed because of CABSI in the ethanol group (ethanol, N=5; heparin, N=12; p=0.08). No patients died because of CABSI. During ethanol locks patients experienced significantly more transient symptoms compared to heparin locks (maximum grade 2) (nausea, p=0.03; taste alteration, p < 0.001; dizziness, p=0.001; blushing, p < 0.001), no suspected unexpected serious adverse reactions (SUSAR) occurred. Conclusions: This RCT showed that ethanol locks can prevent CABSI in pediatric oncology patients, in particular CABSI caused by Gram‐positive bacteria. Implementation of ethanol locks in daily practice should be considered.