Study of Catheter-related Infections Using Antibiotic-coated Versus Conventional Catheters in Children

Phase 4

Terminated

Interventions: Device: Non-impregnated Catheters (C/S)
Device: Antibiotic-impregnated Catheters (M/R)

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Non-impregnated Catheter (C/S)	Non-impregnated Catheters (C/S)	Intervention is insertion intra-operatively of conventional, non-impregnated catheters. There are two sizes to accommodate children in different size ranges: Cook Incorporated Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J), and 5 Fr., 12 cm long (C-UDLM-501J-RSC).
Antibiotic-impregnated Catheters (M/R)	Antibiotic-impregnated Catheters (M/R)	Interventions is insertion intra-operatively of catheters impregnated with minocycline and rifampin to determine if their is a therapeutic difference between this catheter and the placebo (non-impregnated) catheter. The catheters are sized to accommodate children in different size ranges: Cook Inc. Double Lumen 4 Fr., 8 cm long, (C-UDLM-401J-ABRM-HC), 5 Fr., 8 cm long, (C-UDLM-501J-ABRM-HC), and 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM-HC).

Primary Outcome Measures

Name	Time	Method
Incidence of Catheter-related Bloodstream Infections (CRBSI) Per 1000 Catheter Days	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 Outcome Measures

Name	Time	Method
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.	A secondary outcome measure was episodes of clinical sepsis and/or infection with identified source other than the CVC.
Death	Participants were followed for the duration of the hospital stay, an average of 6 days.	Patient Death during hospitalization.