CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 120 enrolled
Drug / intervention
Ethanol-lockdrug
Likely dose
Ethanol-lock 0.3 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03253887
NCT03253887Phase 3Completed

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

Instituto Materno Infantil Prof. Fernando Figueira·interventional·Posted Aug 18, 2017·Updated Nov 1, 2019

In Brief

A Phase 3 clinical trial evaluating Ethanol-lock for Infection, Catheter-Related and 2 related conditions. Completed, enrolled 120 participants across 1 site.

Detailed 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.

Study Details

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 18, 2017
Enrollment StartMar 1, 2016
Primary CompletionApr 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 8.9 years ago

Interventions

Ethanol-lockdrug

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.