A Randomized, Controlled Trial of Catheter Related Infectious Event Rates Using Antibiotic-impregnated Catheters vs. Conventional Catheters in Pediatric Cardiovascular Surgery Patients
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 326
- 试验地点
- 1
- 主要终点
- Incidence of Catheter-related Bloodstream Infections (CRBSI) Per 1000 Catheter Days
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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).
干预措施: Antibiotic-impregnated Catheters (M/R) (Device)
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).
干预措施: Non-impregnated Catheters (C/S) (Device)
结局指标
主要结局
Incidence of Catheter-related Bloodstream Infections (CRBSI) Per 1000 Catheter Days
时间窗: 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.
次要结局
- 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.)