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Completed

NCT Number: NCT03253887

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

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.

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Key information

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Instituto de Medicina Integral Prof Fernando Figueira

Recife, Pernambuco, 50070-550, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Ethanol 70%, Alcohol 70%

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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)

  3. 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

Sponsors and collaborators

Lead sponsor

Instituto Materno Infantil Prof. Fernando Figueira

Other

Collaborators

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

Registry information

Official study title

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

Acronym: E-LockPed

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 18, 2017
Registry last updated
Nov 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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