Clinical trial NCT03253887: Ethanol-lock Therapy for the Prevention of Non-tunneled Catheter-related Infection in Pediatric Patients
Official title: Effectiveness of Ethanol-Lock Therapy for the Prevention of Non-Tunneled Catheter-Related Bloodstream Infection in Pediatric Patients: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infection, Catheter-Related
Central Line-associated Bloodstream Infection (CLABSI)
Pediatric
Keywords: Central Venous Catheters
Child
ethanol therapy
CLABSI
Lead sponsor: Instituto Materno Infantil Prof. Fernando Figueira
Sponsor class: OTHER
Collaborators: name: Bellisa Caldas Lopes
name: Thuanne Beatriz Silva Tenório
name: Rodrigo Melo Gallindo
name: Paulo Sérgio Gomes Nogueira Borges
name: Lara Barreto Machado
First posted: 2017-08-18
Enrollment: 120
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It's a randomized controlled clinical trial.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of central line associated bloodstream infection (CLABSI) episodes in each group and compare them
timeFrame: Period from 48 hours after catheter insertion to 24 hours after catheter removal
Secondary outcomes:
measure: main etiological agents involved in central line associated bloodstream infection (CLABSI) events
timeFrame: 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.
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: During the use of ethanol-lock therapy
measure: Incidence of mechanical effects of ethanol-lock on the catheter (catheter breakage and obstruction)
timeFrame: During the use of ethanol-lock therapy
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Instituto de Medicina Integral Prof Fernando Figueira
state: Pernambuco
Study officials:
affiliation: Instituto de Medicina Integral Prof Fernando Figueira
name: Bellisa C Lopes, Master
role: PRINCIPAL_INVESTIGATOR
References:
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