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

Instituto Materno Infantil Prof. Fernando Figueira

Status and phase: Completed; Phase 3

Conditions: Infection, Catheter-Related; Central Line-associated Bloodstream Infection (CLABSI); Pediatric

Treatments: Drug: Ethanol-lock

Study type: Interventional

Funder types: Other

Identifiers

NCT03253887

55008116.8.0000.5201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: Under 5 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Ethanol-lock therapy (ELT) Group

Experimental group

Description:

This group received daily alcohol 70% (ethanol-lock) with intraluminal alcoholization of both lumens of the central venous catheters

Treatment:

Drug: Ethanol-lock

Control Group

No Intervention group

Description:

This group did not receive the ethanol-lock, being only followed daily and treated according to the standard protocol in operation at this healthcare unit.