Preventing infections in children with heart conditions using tissue adhesive
The Impact of Central-line Exit-site Sealing With 2-octyl Cyanoacrylate Adhesive on CLABSI in Pediatric Cardiac Intensive Care Unit
NA · Rabin Medical Center · NCT05721677
This study is testing if using a special glue at the site of central lines can help prevent infections in children with heart conditions who are at high risk.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 0 Days to 18 Years |
| Sex | All |
| Sponsor | Rabin Medical Center (other) |
| Locations | 1 site (Petah Tikva) |
| Trial ID | NCT05721677 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of applying a tissue adhesive, specifically 2-octyl cyanoacrylate, at the exit site of central lines to reduce the incidence of central-line associated blood stream infections (CLABSI) in high-risk pediatric patients with congenital heart disease. The research focuses on patients admitted to the pediatric cardiac intensive care unit (PCICU) who are particularly vulnerable to these infections. By utilizing a commonly used adhesive known for its safety and feasibility in pediatric care, the study seeks to explore a novel approach to infection prevention in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric patients under one year old with specific risk factors for CLABSI, such as those undergoing congenital heart surgery or requiring prolonged preoperative care.
Not a fit: Patients currently experiencing bacteremia or those with existing central lines or PICCs will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the rates of CLABSI in vulnerable pediatric patients, improving their overall health outcomes.
How similar studies have performed: While the use of tissue adhesives in pediatric care has been explored, this specific application for preventing CLABSI in high-risk cardiac patients is novel and has not been previously studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: All patients admitted to pediatric cardiac ICU (PCICU) defined as high-risk for CLABSI (any of): * young age\<1y \& Congenital Heart Surgery Mortality Category (STAT\\STS-EACTS) score 2-5 * Risk Adjustment for Congenital Heart Surgery (RACHS) category ≥3 * preoperative length-of-stay (LOS) \>7 days * preoperative ventilator support * presence of a genetic abnormality * extracorporeal membrane oxygenation (ECMO) support Exclusion Criteria: * Patients with on-going bacteremia * patients with pre-existing central-line or peripherally inserted central catheter (PICC) * parental refusal to participate.
Where this trial is running
Petah Tikva
- Schneider's children medical center — Petah Tikva, Israel (RECRUITING)
Study contacts
- Study coordinator: Eran Shostak, MD
- Email: eransho@clalit.org.il
- Phone: 972-3-9253114
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Central-line Associated Blood Stream Infections, CLABSI, Pediatric, Cardiac intensive care, cyanoacrylate, tissue adhesive