drugset / Trial / NCT03253887
Ethanol-lock Therapy for the Prevention of Non-tunneled Catheter-related Infection in Pediatric Patients
Phase 3
Completed
120 enrolled
Instituto Materno Infantil Prof. Fernando Figueira
Bellisa Caldas Lopes · collabLara Barreto Machado · collabPaulo Sérgio Gomes Nogueira Borges · collabRodrigo Melo Gallindo · collabThuanne Beatriz Silva Tenório · collab
RandomizedParallel-groupSingle-blindPrevention
Summary
Central venous catheter (CVC) infection is a common complication in pediatric patients, resulting in prolonged length of stay in hospital, requiring antibiotics, invasive procedures and increase morbidity and mortality. Given the repercussion of this complication, measures that minimize its should be stimulated. The purpose of this study is to evaluate the effects of intraluminal alcoholization (ethanol lock therapy) on prevention of infection of short-term central venous catheters in pediatric patients.
Timeline
- Start
- 2016-03
- Primary completion
- 2017-04
- Completion
- 2017-04
Publications
- Background Flynn PM. Diagnosis and management of central venous catheter-related bloodstream infections in pediatric patients. Pediatr Infect Dis J. 2009 Nov;28(11):1016-7. doi: 10.1097/INF.0b013e3181bf7bfc. No abstract available.
- Background Ullman AJ, Cooke ML, Mitchell M, Lin F, New K, Long DA, Mihala G, Rickard CM. Dressings and securement devices for central venous catheters (CVC). Cochrane Database Syst Rev. 2015 Sep 10;2015(9):CD010367. doi: 10.1002/14651858.CD010367.pub2.
- Background Rosado V, Romanelli RM, Camargos PA. Risk factors and preventive measures for catheter-related bloodstream infections. J Pediatr (Rio J). 2011 Nov-Dec;87(6):469-77. doi: 10.2223/JPED.2134.
- Background Subha Rao SD, Joseph MP, Lavi R, Macaden R. Infections related to vascular catheters in a pediatric intensive care unit. Indian Pediatr. 2005 Jul;42(7):667-72.
- Background Cruzeiro PC, Camargos PA, Miranda ME. Central venous catheter placement in children: a prospective study of complications in a Brazilian public hospital. Pediatr Surg Int. 2006 Jun;22(6):536-40. doi: 10.1007/s00383-006-1671-2. Epub 2006 May 5.
- Background Huang EY, Chen C, Abdullah F, Aspelund G, Barnhart DC, Calkins CM, Cowles RA, Downard CD, Goldin AB, Lee SL, St Peter SD, Arca MJ; 2011 American Pediatric Surgical Association Outcomes and Clinical Trials Committee. Strategies for the prevention of central venous catheter infections: an American Pediatric Surgical Association Outcomes and Clinical Trials Committee systematic review. J Pediatr Surg. 2011 Oct;46(10):2000-11. doi: 10.1016/j.jpedsurg.2011.06.017.
- Background Webster J, Gillies D, O'Riordan E, Sherriff KL, Rickard CM. WITHDRAWN: Gauze and tape and transparent polyurethane dressings for central venous catheters. Cochrane Database Syst Rev. 2016 May 4;2016(5):CD003827. doi: 10.1002/14651858.CD003827.pub3.
- Background Costello JM, Morrow DF, Graham DA, Potter-Bynoe G, Sandora TJ, Laussen PC. Systematic intervention to reduce central line-associated bloodstream infection rates in a pediatric cardiac intensive care unit. Pediatrics. 2008 May;121(5):915-23. doi: 10.1542/peds.2007-1577.
- Background Wolf J, Shenep JL, Clifford V, Curtis N, Flynn PM. Ethanol lock therapy in pediatric hematology and oncology. Pediatr Blood Cancer. 2013 Jan;60(1):18-25. doi: 10.1002/pbc.24249. Epub 2012 Aug 21.
- Background Shenep LE, Shenep MA, Cheatham W, Hoffman JM, Hale A, Williams BF, Perkins R, Hewitt CB, Hayden RT, Shenep JL. Efficacy of intravascular catheter lock solutions containing preservatives in the prevention of microbial colonization. J Hosp Infect. 2011 Dec;79(4):317-22. doi: 10.1016/j.jhin.2011.07.010. Epub 2011 Sep 25.
- Background Wales PW, Kosar C, Carricato M, de Silva N, Lang K, Avitzur Y. Ethanol lock therapy to reduce the incidence of catheter-related bloodstream infections in home parenteral nutrition patients with intestinal failure: preliminary experience. J Pediatr Surg. 2011 May;46(5):951-6. doi: 10.1016/j.jpedsurg.2011.02.036.
- Background Sanders J, Pithie A, Ganly P, Surgenor L, Wilson R, Merriman E, Loudon G, Judkins R, Chambers S. A prospective double-blind randomized trial comparing intraluminal ethanol with heparinized saline for the prevention of catheter-associated bloodstream infection in immunosuppressed haematology patients. J Antimicrob Chemother. 2008 Oct;62(4):809-15. doi: 10.1093/jac/dkn284. Epub 2008 Jul 11.
- Background Chambers ST, Peddie B, Pithie A. Ethanol disinfection of plastic-adherent micro-organisms. J Hosp Infect. 2006 Jun;63(2):193-6. doi: 10.1016/j.jhin.2006.01.009. Epub 2006 Apr 4.
- Background Abu-El-Haija M, Schultz J, Rahhal RM. Effects of 70% ethanol locks on rates of central line infection, thrombosis, breakage, and replacement in pediatric intestinal failure. J Pediatr Gastroenterol Nutr. 2014 Jun;58(6):703-8. doi: 10.1097/MPG.0000000000000354.
- Background Crnich CJ, Halfmann JA, Crone WC, Maki DG. The effects of prolonged ethanol exposure on the mechanical properties of polyurethane and silicone catheters used for intravascular access. Infect Control Hosp Epidemiol. 2005 Aug;26(8):708-14. doi: 10.1086/502607.
- Background Opilla MT, Kirby DF, Edmond MB. Use of ethanol lock therapy to reduce the incidence of catheter-related bloodstream infections in home parenteral nutrition patients. JPEN J Parenter Enteral Nutr. 2007 Jul-Aug;31(4):302-5. doi: 10.1177/0148607107031004302.
- Background Chhim RF, Crill CM, Collier HK, Arnold SR, Pourcyrous M, Meibohm B, Christensen M. Ethanol lock therapy: a pilot infusion study in infants. Ann Pharmacother. 2015 Apr;49(4):431-6. doi: 10.1177/1060028015569881. Epub 2015 Jan 28.
- Background Upadhyayula S, Kambalapalli M, Harrison CJ. Safety of anti-infective agents for skin preparation in premature infants. Arch Dis Child. 2007 Jul;92(7):646-7. doi: 10.1136/adc.2007.117002. No abstract available.
- Background Mermel LA, Alang N. Adverse effects associated with ethanol catheter lock solutions: a systematic review. J Antimicrob Chemother. 2014 Oct;69(10):2611-9. doi: 10.1093/jac/dku182. Epub 2014 Jun 2.
- Background Sharma V, Sharma A, Kumar V, Aggarwal S. Disulfiram-like reaction with ornidazole. J Postgrad Med. 2009 Oct-Dec;55(4):292-3. doi: 10.4103/0022-3859.58940.
- Background Karamanakos PN, Pappas P, Boumba VA, Thomas C, Malamas M, Vougiouklakis T, Marselos M. Pharmaceutical agents known to produce disulfiram-like reaction: effects on hepatic ethanol metabolism and brain monoamines. Int J Toxicol. 2007 Sep-Oct;26(5):423-32. doi: 10.1080/10915810701583010.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alcohol | Other / unclassified | 70 % | Other |