NCT03253887

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Instituto Materno Infantil Prof. Fernando Figueira · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infection, Catheter-Related
• Central Line-associated Bloodstream Infection (CLABSI)
• Pediatric

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-04-01
• Completion: 2017-04-01
• First posted: 2017-08-18
• Last updated: 2019-11-01

Locations

1 site across 1 country: Brazil