Study of Catheter-related Infections Using Antibiotic-coated Versus Conventional Catheters in Children
|ClinicalTrials.gov Identifier: NCT00370149|
Recruitment Status : Terminated (Blinded interim analysis resulted in early termination of the study.)
First Posted : August 30, 2006
Results First Posted : February 24, 2016
Last Update Posted : February 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Infection Prevention||Device: Antibiotic-impregnated Catheters (M/R) Device: Non-impregnated Catheters (C/S)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||326 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Controlled Trial of Catheter Related Infectious Event Rates Using Antibiotic-impregnated Catheters vs. Conventional Catheters in Pediatric Cardiovascular Surgery Patients|
|Study Start Date :||September 2006|
|Primary Completion Date :||May 2010|
|Study Completion Date :||May 2010|
Active Comparator: 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).
Device: Antibiotic-impregnated Catheters (M/R)
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.
Placebo Comparator: Non-impregnated Catheter (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).
Device: Non-impregnated Catheters (C/S)
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.
- 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.
- Episodes of Clinical Sepsis and/or Infection With Identified Source Other Than Catheter [ Time Frame: 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 [ Time Frame: Participants were followed for the duration of the hospital stay, an average of 6 days. ]Patient Death during hospitalization.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00370149
|United States, Indiana|
|Riley Hospital for Children|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Elaine G. Cox, MD||Indiana University School of Medicine|