Ethanol-lock Therapy for the Prevention of Non-tunneled Catheter-related Infection in Pediatric Patients

NCT03253887 | Completed Phase 3

• 1 other identifier: 55008116.8.0000.5201
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infection, Catheter-Related; Central Line-associated Bloodstream Infection (CLABSI); Pediatric

Keywords

Central Venous Catheters; Child; ethanol therapy; CLABSI

Outcome Measures

Primary Outcomes (1)

• Number of central line associated bloodstream infection (CLABSI) episodes in each group and compare them

  Measure of Central line associated bloodstream infection (CLABSI) rate per 1000 catheter-days compared between the groups, according to CDC's National Healthcare Safety Network (CDC/NHSN) 2015 definitions.

  Period from 48 hours after catheter insertion to 24 hours after catheter removal

Secondary Outcomes (3)

• main etiological agents involved in central line associated bloodstream infection (CLABSI) events

  Considering that blood specimens were collected 48 hours after catheter insertion and up to 24 hours after catheter removal, from July 2016 to April 2017.

• Incidence of Treatment-Emergent Adverse Events

  During the use of ethanol-lock therapy

• Incidence of mechanical effects of ethanol-lock on the catheter (catheter breakage and obstruction)

  During the use of ethanol-lock therapy

Study Arms (2)

Ethanol-lock therapy (ELT) Group

EXPERIMENTAL

This group received daily alcohol 70% (ethanol-lock) with intraluminal alcoholization of both lumens of the central venous catheters

Drug: Ethanol-lock

Control Group

NO INTERVENTION

This group did not receive the ethanol-lock, being only followed daily and treated according to the standard protocol in operation at this healthcare unit.

Interventions

Ethanol-lock DRUG

This group received daily alcohol 70% (ethanol-lock) received intraluminal ethanol at a volume sufficient to fill the catheter lumen, ranged from 0.1 to 0.3 ml, with the volume being previously established. ELT was maintained for two full hours in each catheter lumen, with the lumen remaining locked during this period. The same procedure was then carried out with the other lumen. Prior to and following ELT, flushing was performed using 5-10 ml of 0.9% saline solution.

Also known as: Ethanol 70%, Alcohol 70%

Ethanol-lock therapy (ELT) Group

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric surgery patients;
• Weight: 2 Kg or more;
• Using non-tunneled double-lumen polyurethane central venous catheter;
• CVC inserted at operation room, Pediatric Intensive Care Unit (PICU) or Neonatal Intensive Care Unit (NICU);
• CVC adequately positioned (checked by radioscopy ou radiography);
• CVC implanted within a maximum of 24 hours.

You may not qualify if:

• Patients whose catheters had been inserted under emergency situations;
• Patients in a critical condition (those requiring continuous fluid/drug infusion through both lumens);
• Patients with a history of hypersensitivity or allergic reactions to ethanol were excluded from the study.

Sponsors & Collaborators

• Instituto Materno Infantil Prof. Fernando Figueira: lead
• Bellisa Caldas Lopes: collaborator
• Thuanne Beatriz Silva Tenório: collaborator
• Rodrigo Melo Gallindo: collaborator
• Paulo Sérgio Gomes Nogueira Borges: collaborator
• Lara Barreto Machado: collaborator

Study Sites (1)

Instituto de Medicina Integral Prof Fernando Figueira

Recife, Pernambuco, 50070-550, Brazil

Location

Related Publications (21)

• 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.

  PMID: 19859018 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.

  PMID: 26358142 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.

  PMID: 22170387 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.

  PMID: 16085967 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.

  PMID: 16736225 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.

  PMID: 22008341 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.

  PMID: 27144903 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.

  PMID: 18450894 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.

  PMID: 22911535 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.

  PMID: 21945067 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.

  PMID: 21616259 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.

  PMID: 18621987 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.

  PMID: 16600429 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.

  PMID: 24590214 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.

  PMID: 16156328 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.

  PMID: 17595439 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.

  PMID: 25632063 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.

  PMID: 17588981 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.

  PMID: 24891431 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.

  PMID: 20083883 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.

  PMID: 17963129 BACKGROUND

MeSH Terms

Conditions

Catheter-Related Infections

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Bellisa C Lopes, Master

  Instituto de Medicina Integral Prof Fernando Figueira

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Following inclusion, the patients were randomized into two groups, the ethanol-lock group and the control group, using allocation concealment with a list of random numbers generated using the Random Allocation Software
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: It's a randomized controlled clinical trial.

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: August 18, 2017
• Study Start: March 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: November 1, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)