A Randomized, Controlled Trial of Catheter Related Infectious Event Rates Using Antibiotic-impregnated Catheters vs. Conventional Catheters in Pediatric Cardiovascular Surgery Patients
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Enrollment
- 326
- Locations
- 2
- Primary Endpoint
- Incidence of Catheter-related Bloodstream Infections (CRBSI) Per 1000 Catheter Days
Study Overview
Brief Summary
The primary purpose of the study is to determine if a therapeutic difference exists between central venous catheters impregnated with minocycline and rifampin and conventional catheters not impregnated with antibiotics when used in children at high risk for bloodstream infections (CABSI) after cardiac surgery.
Detailed Description
The standard central venous catheter (CVC) is now commonly used for infants, children, and adults. The antibiotic-coated CVC is a newer CVC gaining popularity for use in adults. The Food and Drug Administration (FDA) and the Center for Disease Control (CDC) support use of the antibiotic-coated CVC for adult patients. But the FDA and CDC have not yet endorsed use of the antibiotic-coated CVC for infants and children due to lack of research on this CVC in infants and children.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- — to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age < 18 years
- •Cardiovascular surgery patient with a case complexity warranting CVC placement longer than 3 days
- •Study devices of appropriate size for patient use without modification
- •Informed consent obtained prior to patient entering the operating room
Exclusion Criteria
- •Age ≥ 18 years
- •Drug allergy to minocycline, other tetracyclines, or rifampin
- •Ventricular assist device (VAD) therapy
- •Extracorporeal membrane oxygenation (ECMO) therapy
- •Patients undergoing cardiac transplant
- •Any active infection or being treated for bacteremia at the time of randomization
Outcomes
Primary Outcomes
Incidence of Catheter-related Bloodstream Infections (CRBSI) Per 1000 Catheter Days
Time Frame: Participants were followed for the duration of the hospital stay, an average of 6 days.
Rates of CRBSI defined as 1. micro-organism isolated from a blood culture; 2. Clinical manifestations of infection such as fever (≥38 C) and/or hypotension (defined according to age-related practice guidelines for systolic blood pressure); 3. No apparent source for the bloodstream infection except for the catheter.
Secondary Outcomes
- Episodes of Clinical Sepsis and/or Infection With Identified Source Other Than Catheter(Participants were followed for the duration of hospital stay, an average of 6 days.)
- Death(Participants were followed for the duration of the hospital stay, an average of 6 days.)