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

NCT03253887 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-11-01

No results posted yet for this study

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

Interventions

DRUG

Ethanol-lock

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.

Sponsors & Collaborators

  • Bellisa Caldas Lopes

    collaborator UNKNOWN

  • Thuanne Beatriz Silva Tenório

    collaborator UNKNOWN

  • Rodrigo Melo Gallindo

    collaborator UNKNOWN

  • Paulo Sérgio Gomes Nogueira Borges

    collaborator UNKNOWN

  • Lara Barreto Machado

    collaborator UNKNOWN

  • Instituto Materno Infantil Prof. Fernando Figueira

    lead OTHER

Principal Investigators

  • Bellisa C Lopes, Master · Instituto de Medicina Integral Prof Fernando Figueira

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-04-30
Completion
2017-04-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03253887 on ClinicalTrials.gov