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

Last updated: October 29, 2019
Sponsor: Instituto Materno Infantil Prof. Fernando Figueira
Overall Status: Completed

Phase

3

Condition

Catheter Complications

Treatment

N/A

Clinical Study ID

NCT03253887
55008116.8.0000.5201
  • Ages < 5
  • All Genders

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.

Eligibility Criteria

Inclusion

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 NeonatalIntensive Care Unit (NICU);

  • CVC adequately positioned (checked by radioscopy ou radiography);

  • CVC implanted within a maximum of 24 hours.

Exclusion

Exclusion Criteria:

  • Patients whose catheters had been inserted under emergency situations;

  • Patients in a critical condition (those requiring continuous fluid/drug infusionthrough both lumens);

  • Patients with a history of hypersensitivity or allergic reactions to ethanol wereexcluded from the study.

Study Design

Total Participants: 120
Study Start date:
March 01, 2016
Estimated Completion Date:
April 30, 2017

Study 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.

Connect with a study center

  • Instituto de Medicina Integral Prof Fernando Figueira

    Recife, Pernambuco 50070-550
    Brazil

    Site Not Available

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