title: Prevention of central venous catheter-associated bloodstream infections in paediatric oncology patients using 70% ethanol locks: A randomised controlled multi-centre trial.
abstract: BACKGROUND
  The prevention of central venous catheter (CVC) associated bloodstream infections (CABSIs) in paediatric oncology patients is essential. Ethanol locks can eliminate pathogens colonising CVCs and microbial resistance is rare. Aim of this study was to determine whether two hour 70% ethanol locks can reduce CABSI in paediatric oncology patients.
  
  
  METHODS
  We conducted a randomised, double blind, multi-centre trial in paediatric oncology patients (1-18 years) with newly inserted CVCs. Patients were randomly assigned to receive two hour ethanol locks (1.5 or 3 ml 70%) or heparin locks (1.5 or 3 ml 100 IU/ml), whenever it was needed to use the CVC, maximum frequency once weekly. Primary outcomes were time to CABSI or death due to CABSI.
  
  
  RESULTS
  We recruited 307 patients (ethanol, n=153; heparin, n=154). In the ethanol group, 16/153 (10%) patients developed a CABSI versus 29/154 (19%) in the heparin group. The incidence of CABSI was 0.77/1000 and 1.46/1000 catheter days respectively (p=0.039). The number-needed-to-treat was 13. No patients died of CABSI. In particular, Gram-positive CABSIs were reduced (ethanol, n=8; heparin, n=21; p=0.012). Fewer CVCs were removed because of CABSI in the ethanol group (p=0.077). The ethanol lock patients experienced significantly more transient symptoms compared to the heparin lock patients (maximum grade 2) (nausea, p=0.030; taste alteration, p<0.001; dizziness, p=0.001; blushing, p<0.001), no suspected unexpected serious adverse reactions (SUSAR) occurred.
  
  
  CONCLUSIONS
  This is the first randomised controlled trial to show that ethanol locks can prevent CABSI in paediatric oncology patients, in particular CABSI caused by Gram-positive bacteria. Implementation of ethanol locks in clinical practice should be considered.
authors.affiliation: Department of Paediatric Oncology, Emma Children's Hospital, Academic Medical Centre, Amsterdam, The Netherlands. Electronic address: r.a.schoot@amc.uva.nl.
authors.forename: Reineke A
authors.initials: RA
authors.lastname: Schoot
authors.affiliation: Department of Paediatric Haematology, Emma Children's Hospital, Academic Medical Centre, Amsterdam, The Netherlands. Electronic address: c.h.vanommen@amc.uva.nl.
authors.forename: C Heleen
authors.initials: CH
authors.lastname: van Ommen
authors.affiliation: Department of Medical Statistics and Bioinformatics, Leiden University Medical Centre, Leiden, The Netherlands. Electronic address: t.stijnen@lumc.nl.
authors.forename: Theo
authors.initials: T
authors.lastname: Stijnen
authors.affiliation: Department of Paediatric Oncology, Beatrix Children's Hospital, University Medical Centre Groningen, Groningen, The Netherlands. Electronic address: w.j.e.tissing@umcg.nl.
authors.forename: Wim J E
authors.initials: WJ
authors.lastname: Tissing
authors.affiliation: Department of Paediatric Oncology/Haematology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands. Electronic address: e.michiels@erasmusmc.nl.
authors.forename: Erna
authors.initials: E
authors.lastname: Michiels
authors.affiliation: Department of Paediatric Oncology/Haematology, VU University Medical Centre, Amsterdam, The Netherlands. Electronic address: f.abbink@vumc.nl.
authors.forename: Floor C H
authors.initials: FC
authors.lastname: Abbink
authors.affiliation: Department of Paediatric Oncology/Haematology, Wilhelmina Children's Hospital, Utrecht, The Netherlands. Electronic address: m.raphael@vumc.nl.
authors.forename: Martine F
authors.initials: MF
authors.lastname: Raphael
authors.affiliation: Paediatric Surgical Centre Amsterdam, Academic Medical Centre & VU University Medical Centre, Amsterdam, The Netherlands. Electronic address: h.a.heij@hetnet.nl.
authors.forename: Hugo A
authors.initials: HA
authors.lastname: Heij
authors.affiliation: Dutch Childhood Oncology Group, The Hague, The Netherlands. Electronic address: jlieverst@skion.nl.
authors.forename: Jan A
authors.initials: JA
authors.lastname: Lieverst
authors.affiliation: Department of Medical Microbiology, Academic Medical Centre, Amsterdam, The Netherlands. Electronic address: l.spanjaard@amc.uva.nl.
authors.forename: Lodewijk
authors.initials: L
authors.lastname: Spanjaard
authors.affiliation: Department of Paediatric Oncology/Haematology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands. Electronic address: c.m.zwaan@erasmusmc.nl.
authors.forename: C Michel
authors.initials: CM
authors.lastname: Zwaan
authors.affiliation: Department of Paediatric Oncology, Emma Children's Hospital, Academic Medical Centre, Amsterdam, The Netherlands. Electronic address: h.n.caron@amc.uva.nl.
authors.forename: Huib N
authors.initials: HN
authors.lastname: Caron
authors.affiliation: Department of Paediatric Oncology, Emma Children's Hospital, Academic Medical Centre, Amsterdam, The Netherlands. Electronic address: m.d.vandewetering@amc.uva.nl.
authors.forename: Marianne D
authors.initials: MD
authors.lastname: van de Wetering
mesh_terms: D000293:Adolescent; D000367:Age Factors; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D055499:Catheter-Related Infections / Q000097:blood / Q000175:diagnosis / Q000382:microbiology / Q000517:prevention & control*; D002405:Catheterization, Central Venous / Q000009:adverse effects* / Q000295:instrumentation*; D062905:Central Venous Catheters / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D000431:Ethanol / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006493:Heparin / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007223:Infant; D008297:Male; D009369:Neoplasms / Q000188:drug therapy*; D009426:Netherlands; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D000925:Anticoagulants; D000431:Ethanol; D006493:Heparin
keywords: Bloodstream infection; Central venous catheter; Ethanol; Paediatric oncology