Have you or your loved ones been diagnosed with central line-associated bloodstream infection (clabsi)?

You may be eligible to participate in a central line-associated bloodstream infection (clabsi) clinical trial.

Have you or your loved ones been diagnosed with central line-associated bloodstream infection (clabsi)? You may be eligible to participate in a central line-associated bloodstream infection (clabsi) clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Central Line-associated Bloodstream Infection (CLABSI) Clinical Trial in Recife Pernambuco

NCT03253887 | Phase 3 | Interventional

Have you or your loved ones been diagnosed with central line-associated bloodstream infection (clabsi)?

You may be eligible to participate in a central line-associated bloodstream infection (clabsi) clinical trial.

Completed

Male & Female

Up to 5

Years old

This study has recruited 120 Participants

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.

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Details for the study

Brief Title

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

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.

Treatments and/or Procedures

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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

Number of central line associated bloodstream infection (CLABSI) episodes in each group and compare them

Measure of Central line associated bloodstream infection (CLABSI) rate per 1000 catheter-days compared between the groups, according to CDC's National Healthcare Safety Network (CDC/NHSN) 2015 definitions.

Period from 48 hours after catheter insertion to 24 hours after catheter removal

Secondary

main etiological agents involved in central line associated bloodstream infection (CLABSI) events

The organisms responsable for each CLABSI event: gram negatives, gram positives or fungus. Identified by one or more blood specimens by a culture or non-culture based microbiologic testing method and the organism(s) identified in blood is not related to an infection at another site

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.

Secondary

Incidence of Treatment-Emergent Adverse Events

Number of episodes of adverse events (dizziness, headache, dyspnea, chest pain, alcohol taste, facial flushing, nausea, vomiting, pruritus, sneezing, slurred speech, irritability)

During the use of ethanol-lock therapy

Secondary

Incidence of mechanical effects of ethanol-lock on the catheter (catheter breakage and obstruction)

Evaluate mechanical effects of ethanol-lock on the catheter, by the number of participants with catheter breakage or catheter obstruction in each group

During the use of ethanol-lock therapy

Study 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.