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

• Catheter-related bloodstream infection (CRBSI)
• Local infection
• Culture negative episodes of empiric (rule out) antibiotics
• Culture negative episodes of clinical sepsis
• Infection with identified source other than catheter
• No infection upon catheter removal
• Catheter complications (occlusion, fracture)
• Death

• Cost-effectiveness of each catheter based on the rate of catheter complications between the two catheters, ICU days, ventilator days, total hospital duration, and antibiotic days [ Time Frame: While catheter placed and hospital admission ] [ Designated as safety issue: No ]
• Episodes of clinical sepsis and/or infection with identified source other than catheter [ Time Frame: While catheter placed ] [ Designated as safety issue: No ]
• Death [ Time Frame: Hospital admission ] [ Designated as safety issue: No ]

• Cost-effectiveness of each catheter based on the rate of catheter complications between the two catheters
• ICU Days
• Ventilator Days
• Total hospital duration
• Antibiotic days

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 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.

• Device: Cook Incorporated C-UDLM-401J and C-UDLM-401J-ABRM
  Patients randomized to this arm will have the central venous catheter inserted intraoperatively
• Device: Cook Incorporated C-UDLM-401J and C-UDLMY-501J
  Patients randomized to this arm will have the central venous catheter inserted intraoperatively

• Active Comparator: 1
  Cook Incorporated Spectrum Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J-ABRM), and 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM-FST) impregnated with minocycline and rifampin
  Intervention: Device: Cook Incorporated C-UDLM-401J and C-UDLM-401J-ABRM
• Placebo Comparator: 2
  Cook Incorporated Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 12 cm long, (C-UDLMY-501J)
  Intervention: Device: Cook Incorporated C-UDLM-401J and C-UDLMY-501J

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