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

October 29, 2019 updated by: Flavia orange, Instituto Materno Infantil Prof. Fernando Figueira

Effectiveness of Ethanol-Lock Therapy for the Prevention of Non-Tunneled Catheter-Related Bloodstream Infection in Pediatric Patients: A Randomised Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The patients was divided into two groups, where one received alcoholization (ethanol lock therapy group) and the other not (control group). The variables evaluated were: CLABSI, etiological agents, adverse events and the mechanical effects of ethanol on the catheter (breakage and obstruction). To determine the association between the independent variable and the dependent variables, the chi-square test of association (Pearson) and Fisher's exact test were used. The Risk Ratio (RR) was calculated as a relative risk measure, with its 95% confidence interval (95% CI). The significance level of 5% was adopted. The sample size calculation was performed in the OpenEpi software version 2.3.1. And a long-term catheter clinical trial was used to calculate the sample size, which demonstrated a 9% central venous catheter infection frequency in the ethanol group and 37% in the control group, so that the sample size was 80 patients (40 in each group), considering a power of 80%, an alpha error of 5% and 10% of post-randomization losses.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50070-550
        • Instituto de Medicina Integral Prof Fernando Figueira

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ethanol-lock therapy (ELT) Group
This group received daily alcohol 70% (ethanol-lock) with intraluminal alcoholization of both lumens of the central venous catheters
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.
Other Names:
  • Ethanol 70%
  • Alcohol 70%
No Intervention: Control Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of central line associated bloodstream infection (CLABSI) episodes in each group and compare them
Time Frame: Period from 48 hours after catheter insertion to 24 hours after catheter removal
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
main etiological agents involved in central line associated bloodstream infection (CLABSI) events
Time Frame: 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.
The organisms responsable for each CLABSI event: gram negatives, gram positives or fungus. Identified by one or more blood specimens by a culture or non-culture based microbiologic testing method and the organism(s) identified in blood is not related to an infection at another site
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
Time Frame: During the use of ethanol-lock therapy
Number of episodes of adverse events (dizziness, headache, dyspnea, chest pain, alcohol taste, facial flushing, nausea, vomiting, pruritus, sneezing, slurred speech, irritability)
During the use of ethanol-lock therapy
Incidence of mechanical effects of ethanol-lock on the catheter (catheter breakage and obstruction)
Time Frame: During the use of ethanol-lock therapy
Evaluate mechanical effects of ethanol-lock on the catheter, by the number of participants with catheter breakage or catheter obstruction in each group
During the use of ethanol-lock therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Materno Infantil Prof. Fernando Figueira

Collaborators

Bellisa Caldas Lopes
Thuanne Beatriz Silva Tenório
Rodrigo Melo Gallindo
Paulo Sérgio Gomes Nogueira Borges
Lara Barreto Machado

Investigators

  • Principal Investigator: Bellisa C Lopes, Master, Instituto de Medicina Integral Prof Fernando Figueira

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

March 28, 2017

First Submitted That Met QC Criteria

August 15, 2017

First Posted (Actual)

August 18, 2017

Study Record Updates

Last Update Posted (Actual)

November 1, 2019

Last Update Submitted That Met QC Criteria

October 29, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 55008116.8.0000.5201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Study Data/Documents

  1. Study Protocol
    Information comments: Guidelines for the Prevention of Intravascular Catheter-Related Infections, 2011
  2. Study Protocol
    Information comments: Bloodstream Infection Event (Central Line-Associated Bloodstream Infection and non-central line-associated Bloodstream Infection)
  3. Study Protocol
    Information comments: CDC/NHSN Surveillance Definitions for Specific Types of Infections

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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