Status:

COMPLETED

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

Lead Sponsor:

Instituto Materno Infantil Prof. Fernando Figueira

Collaborating Sponsors:

Bellisa Caldas Lopes

Thuanne Beatriz Silva Tenório

Conditions:

Infection, Catheter-Related

Central Line-associated Bloodstream Infection (CLABSI)

Eligibility:

All Genders

Up to 5 years

Phase:

PHASE3

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 morbi...

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, ad...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

March 1 2016

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2017

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT03253887

Start Date

March 1 2016

End Date

April 1 2017

Last Update

November 1 2019

Active Locations (1)

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Instituto de Medicina Integral Prof Fernando Figueira

Recife, Pernambuco, Brazil, 50070-550

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