Clinical trial NCT05721677: CLABSI Prevention With Tissue Adhesive
Official title: The Impact of Central-line Exit-site Sealing With 2-octyl Cyanoacrylate Adhesive on CLABSI in Pediatric Cardiac Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Central-line Associated Blood Stream Infections (CLABSI)
Keywords: CLABSI
Pediatric
Cardiac intensive care
cyanoacrylate
tissue adhesive
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 600
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, open labeled study
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: CLABSI rate
timeFrame: up to 1 year
Secondary outcomes:
measure: dressing changes rates
timeFrame: average of 14 days
measure: 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
timeFrame: average of 14 days
measure: invasive mechanical ventilation duration
timeFrame: up to 1 year
measure: ICU LOS
timeFrame: up to 1 year
measure: Postoperative ECMO support
timeFrame: up to 1 year
measure: Chylothorax
timeFrame: up to 1 year
measure: Chest drains duration
timeFrame: up to 1 year
measure: need for cardiopulmonary resuscitation (CPR)
timeFrame: up to 1 year
measure: Extubation failure
timeFrame: up to 1 year
measure: presence of lung atelectasis
timeFrame: up to 1 year
measure: multidrug resistant bacterial colonization
timeFrame: up to 1 year
measure: mortality rate
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Petach tikva
country: Israel
facility: Schneider's children medical center
Study officials:
affiliation: Director PCICU, Schneider Children's Medical Center
name: Ovadia Dagan, Prof. M.D
role: STUDY_DIRECTOR
References: