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

Phase 3

Completed

• Conditions: Central Line-associated Bloodstream Infection (CLABSI); Pediatric; Infection, Catheter-Related
• Interventions: Drug: Ethanol-lock

• Registration Number: NCT03253887
• Lead Sponsor: Instituto Materno Infantil Prof. Fernando Figueira

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.

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 Timeline

• Study Start: 2016-03
• Study First Submitted: 2017-03-28
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Study First Submitted QC: 2017-08-15
• Study First Posted: 2017-08-18
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-29
• Last Update Posted: 2019-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ethanol-lock therapy (ELT) Group	Ethanol-lock	This group received daily alcohol 70% (ethanol-lock) with intraluminal alcoholization of both lumens of the central venous catheters

Primary Outcome Measures

Name	Time	Method
Number of central line associated bloodstream infection (CLABSI) episodes in each group and compare them	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 Outcome Measures

Name	Time	Method
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.	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
Incidence of Treatment-Emergent Adverse Events	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)
Incidence of mechanical effects of ethanol-lock on the catheter (catheter breakage and obstruction)	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

Trial Locations

Locations (1)

Instituto de Medicina Integral Prof Fernando Figueira; 🇧🇷 Recife, Pernambuco, Brazil