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

NCT ID: NCT03253887

Last Updated: 2019-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-04-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Ethanol-lock therapy (ELT) Group

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

Group Type: EXPERIMENTAL

Ethanol-lock

Intervention Type: DRUG

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.

Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Ethanol 70%; Alcohol 70%

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.

• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bellisa Caldas Lopes

UNKNOWN

Sponsor Role: collaborator

Thuanne Beatriz Silva Tenório

UNKNOWN

Sponsor Role: collaborator

Rodrigo Melo Gallindo

UNKNOWN

Sponsor Role: collaborator

Paulo Sérgio Gomes Nogueira Borges

UNKNOWN

Sponsor Role: collaborator

Lara Barreto Machado

UNKNOWN

Sponsor Role: collaborator

Instituto Materno Infantil Prof. Fernando Figueira

OTHER

Sponsor Role: lead

Responsible Party

Flavia orange

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bellisa C Lopes, Master

Role: PRINCIPAL_INVESTIGATOR

Instituto de Medicina Integral Prof Fernando Figueira

Locations

Instituto de Medicina Integral Prof Fernando Figueira

Recife, Pernambuco, Brazil

Countries

Brazil

References

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Study Documents

Document Type: Study Protocol

Bloodstream Infection Event (Central Line-Associated Bloodstream Infection and non-central line-associated Bloodstream Infection)

View Document

Document Type: Study Protocol

CDC/NHSN Surveillance Definitions for Specific Types of Infections

View Document

Other Identifiers

55008116.8.0000.5201

Identifier Type: -

Identifier Source: org_study_id