Reineke A Schoot1, C Heleen van Ommen2, Theo Stijnen3, Wim J E Tissing4, Erna Michiels5, Floor C H Abbink6, Martine F Raphael7, Hugo A Heij8, Jan A Lieverst9, Lodewijk Spanjaard10, C Michel Zwaan11, Huib N Caron12, Marianne D van de Wetering13. 1. Department of Paediatric Oncology, Emma Children's Hospital, Academic Medical Centre, Amsterdam, The Netherlands. Electronic address: r.a.schoot@amc.uva.nl. 2. Department of Paediatric Haematology, Emma Children's Hospital, Academic Medical Centre, Amsterdam, The Netherlands. Electronic address: c.h.vanommen@amc.uva.nl. 3. Department of Medical Statistics and Bioinformatics, Leiden University Medical Centre, Leiden, The Netherlands. Electronic address: t.stijnen@lumc.nl. 4. Department of Paediatric Oncology, Beatrix Children's Hospital, University Medical Centre Groningen, Groningen, The Netherlands. Electronic address: w.j.e.tissing@umcg.nl. 5. Department of Paediatric Oncology/Haematology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands. Electronic address: e.michiels@erasmusmc.nl. 6. Department of Paediatric Oncology/Haematology, VU University Medical Centre, Amsterdam, The Netherlands. Electronic address: f.abbink@vumc.nl. 7. Department of Paediatric Oncology/Haematology, Wilhelmina Children's Hospital, Utrecht, The Netherlands. Electronic address: m.raphael@vumc.nl. 8. Paediatric Surgical Centre Amsterdam, Academic Medical Centre & VU University Medical Centre, Amsterdam, The Netherlands. Electronic address: h.a.heij@hetnet.nl. 9. Dutch Childhood Oncology Group, The Hague, The Netherlands. Electronic address: jlieverst@skion.nl. 10. Department of Medical Microbiology, Academic Medical Centre, Amsterdam, The Netherlands. Electronic address: l.spanjaard@amc.uva.nl. 11. Department of Paediatric Oncology/Haematology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands. Electronic address: c.m.zwaan@erasmusmc.nl. 12. Department of Paediatric Oncology, Emma Children's Hospital, Academic Medical Centre, Amsterdam, The Netherlands. Electronic address: h.n.caron@amc.uva.nl. 13. Department of Paediatric Oncology, Emma Children's Hospital, Academic Medical Centre, Amsterdam, The Netherlands. Electronic address: m.d.vandewetering@amc.uva.nl.
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.
RCT Entities:
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: Melissa A Shenep; Mary R Tanner; Yilun Sun; Tina Culley; Randall T Hayden; Patricia M Flynn; Li Tang; Joshua Wolf Journal: JPEN J Parenter Enteral Nutr Date: 2016-01-07 Impact factor: 4.016
Authors: C Gudiol; S Nicolae; C Royo-Cebrecos; M Aguilar-Guisado; I Montero; C Martín-Gandul; M Perayre; D Berbel; M Encuentra; M Arnan; J M Cisneros-Herreros; J Carratalà Journal: Trials Date: 2018-05-02 Impact factor: 2.279