Instituto de Medicina Integral Prof Fernando Figueira
Recife, Pernambuco, 50070-550, Brazil
NCT Number: NCT03253887
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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Notify MeUp to 5 year
All sexes
Interventional
Phase 3
Recife, Pernambuco, 50070-550, Brazil
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Ethanol 70%, Alcohol 70%
Time frame: Period from 48 hours after catheter insertion to 24 hours after catheter removal
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.
Time frame: 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.
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
Time frame: During the use of ethanol-lock therapy
Number of episodes of adverse events (dizziness, headache, dyspnea, chest pain, alcohol taste, facial flushing, nausea, vomiting, pruritus, sneezing, slurred speech, irritability)
Time frame: During the use of ethanol-lock therapy
Evaluate mechanical effects of ethanol-lock on the catheter, by the number of participants with catheter breakage or catheter obstruction in each group
Instituto Materno Infantil Prof. Fernando Figueira
Other
Effectiveness of Ethanol-Lock Therapy for the Prevention of Non-Tunneled Catheter-Related Bloodstream Infection in Pediatric Patients: A Randomised Controlled Trial
Acronym: E-LockPed
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