Effect of Active Drain Line Clearance With or Without Silver on Catheter-Associated Bacteriuria (The CAB Study)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Difference in percentage of catheter-associated bacteriuria
研究概览
简要总结
Catheter-associated urinary tract infections (CAUTI) are the most common nosocomial infections in critically ill patients and are responsible for high morbidity rates, increased hospital stays and associated costs.
The purpose of this study is to evaluate whether active drain line clearance by the Accuryn Monitoring System reduces the incidence of CAUTI in hospitalized patients requiring catheters.
详细描述
Urinary tract infection (UTI) is the most common healthcare associated infection (HAI) acquired in hospitals and is estimated to account for approximately 13% of hospital infections in the United States, of which 75% are associated with indwelling urinary catheters. It is estimated that between 12-16% adult inpatients will receive an indwelling urinary catheter during their hospital stay. The rate of catheter-associated UTI (CAUTI) are highest in burn ICUs, followed by inpatient medical wards and neurosurgical ICUs.
The purpose of this study is to evaluate whether active drain line clearance by the Accuryn Monitoring System reduces the incidence of bacteriuria and/or CAUTI in patients requiring catheters for more than 72 hours. This study will also evaluate the efficacy in reducing bacteriuria of the Accuryn silver fabricated silicone catheters.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (age ≥ 18)
- •Patient or Legally Authorized Representative (LAR) possess the capacity to provide informed consent
- •Indication for a urinary bladder catheter (or one currently in place)
- •Expected urinary catheter requirement ≥ 72 hours
- •No current urinary tract infection
- •No current indication for prophylactic antibiotics. If a surgical patient, receive perioperative antibiotics for no greater than 24 hours
排除标准
- •Inability to receive a urinary bladder catheter
- •Chronic suprapubic catheter in place
- •Expected survival < 72 hours
- •Receipt of systemic antibiotics within 48 hours of enrollment, other than prophylactic antibiotics given at the time of surgery
- •Surgery of the genitourinary tract in the past 6 months prior to admission
- •Deemed unfit for the protocol by the investigator for any reason
结局指标
主要结局
Difference in percentage of catheter-associated bacteriuria
时间窗: 30 days
To study the difference in rate of catheter-associated bacteriuria between SOC catheters and Accuryn silicone or Accuryn silver-doped catheters with active drain line clearance.
次要结局
- Urine Culture Comparisons(30 days)
- Percentage of asymptomatic (ASB) and symptomatic (CAUTI) bacteriuria(30 days)
- Time to Bacteriuria (ASB and CAUTI)(30 days)