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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
326
Patients randomized to this arm will have the antibiotic-impregnated catheters inserted intra-operatively. The catheters are sized to accommodate children in different size ranges.
Patients randomized to this arm will have the central venous catheter inserted intra-operatively. The catheters are sized to accommodate children in different size ranges.
Riley Hospital for Children
Indianapolis, Indiana, United States
Incidence of Catheter-related Bloodstream Infections (CRBSI) Per 1000 Catheter 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.
Time frame: Participants were followed for the duration of the hospital stay, an average of 6 days.
Episodes of Clinical Sepsis and/or Infection With Identified Source Other Than Catheter
A secondary outcome measure was episodes of clinical sepsis and/or infection with identified source other than the CVC.
Time frame: Participants were followed for the duration of hospital stay, an average of 6 days.
Death
Patient Death during hospitalization.
Time frame: Participants were followed for the duration of the hospital stay, an average of 6 days.
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