Central-line Associated Blood Stream Infections (CLABSI)
Conditions
Keywords
CLABSI, Pediatric, Cardiac intensive care, cyanoacrylate, tissue adhesive
Brief summary
Our aim is to test the effect of tissue adhesive application at the Central-line exit-site on CLABSI rates in high-risk pediatric congenital heart disease patients.
Detailed description
Health-care associated infections (HAI) and especially central-line associated blood stream infections (CLABSI) are a well described burden in the intensive care units. There are two main possible pathways leading to central-venous line (CVL) related infection: the first is migration of microbes down the catheter tract (between the CVL and the skin), and the second is via the catheter hub/lumen. Cyanoacrylate adhesive is a commonly used tissue adhesive in children and adults with frequent use in pediatric facial lacerations. Several studies have shown its feasibility and safety in the general pediatric population, including neonates and in children after cardiac surgery. To our knowledge, no study to date has explored the use of 2-octyl cyanoacrylate at central-line exit site as a mean to decreases pediatric CLABSI. Our aim is to assess 2-octyl cyanoacrylate association with CLABSI rate in pediatric cardiac intensive care population.
Interventions
DEVICE2-octyl cyanoacrylate based topical skin adhesive
Tissue adhesive on CVL exit-site
Sponsors
Rabin Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Prospective, randomized, open labeled study
Eligibility
Sex/Gender
ALL
Age
0 Days to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CLABSI rate | up to 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| safety outcome: Number pf participants with contact dermatitis at the catheter exit site, line dislodgement, leak, exit site bleeding, allergic reaction or line tunnel infection | average of 14 days | number of patients suffering from contact dermatitis at the catheter exit site, line dislodgement, leak, exit site bleeding, allergic reaction or line tunnel infection |
| invasive mechanical ventilation duration | up to 1 year | days |
| ICU LOS | up to 1 year | days |
| Postoperative ECMO support | up to 1 year | — |
| Chylothorax | up to 1 year | — |
| dressing changes rates | average of 14 days | — |
| need for cardiopulmonary resuscitation (CPR) | up to 1 year | — |
| Extubation failure | up to 1 year | rate |
| presence of lung atelectasis | up to 1 year | — |
| multidrug resistant bacterial colonization | up to 1 year | — |
| mortality rate | up to 1 year | — |
| Chest drains duration | up to 1 year | days |
Countries
Israel
Contacts
Primary ContactEran Shostak, MD
Outcome results
None listed