Central Line-associated Bloodstream Infection (CLABSI), Infection, Catheter-Related, Pediatric
Conditions
Keywords
Central Venous Catheters, Child, ethanol therapy, CLABSI
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.
Interventions
DRUGEthanol-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.
Sponsors
Bellisa Caldas Lopes
Thuanne Beatriz Silva Tenório
Rodrigo Melo Gallindo
Paulo Sérgio Gomes Nogueira Borges
Lara Barreto Machado
Instituto Materno Infantil Prof. Fernando Figueira
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Following inclusion, the patients were randomized into two groups, the ethanol-lock group and the control group, using allocation concealment with a list of random numbers generated using the Random Allocation Software
Intervention model description
It's a randomized controlled clinical trial.
Eligibility
Sex/Gender
ALL
Age
No minimum to 5 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of central line associated bloodstream infection (CLABSI) episodes in each group and compare them | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| main etiological agents involved in central line associated bloodstream infection (CLABSI) events | 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 |
| Incidence of Treatment-Emergent Adverse Events | 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) |
| Incidence of mechanical effects of ethanol-lock on the catheter (catheter breakage and obstruction) | 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 |
Countries
Brazil
Outcome results
None listed