A Phase 3 interventional study of Ethanol-lock in Infection, Catheter-Related, Central Line-associated Bloodstream Infection (CLABSI) and Pediatric, sponsored by Instituto Materno Infantil Prof. Fernando Figueira. Completed at 1 site in Brazil. Open to participants aged Up to 5 Years. Per ClinicalTrials.gov, last updated 2019-11-01.
Sponsored by Instituto Materno Infantil Prof. Fernando Figueira · Phase 3, Interventional, and Prevention
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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.
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.
112 studies on the registry are indexed under Catheter-Related Infections; 18 are open to participants now.
This study's enrollment of 120 is below the median of 149 across 84 interventional studies indexed under Catheter-Related Infections.
Browse Catheter-Related Infections studies →Instituto Materno Infantil Prof. Fernando Figueira is the lead sponsor of 32 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group received daily alcohol 70% (ethanol-lock) with intraluminal alcoholization of both lumens of the central venous catheters
Drug: Ethanol-lock
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.
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.
Also known as: Ethanol 70%, Alcohol 70%
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.
Time frame: Period from 48 hours after catheter insertion to 24 hours after catheter removal
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
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.
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)
Time frame: During the use of ethanol-lock therapy
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
Time frame: During the use of ethanol-lock therapy
Plan to share: No
Ran from Mar 2016 to primary completion in Apr 2017, 13 months.
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This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ethanol
Instituto Materno Infantil Prof. Fernando Figueira