Trial of Ethanol Lock Therapy to Prevent Catheter Associated Blood Stream Infections
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Catheter associated blood stream infection (CABSI).
研究概览
简要总结
This study is designed to determine if the use of 70% ethanol lock solution in central lines decreases the rate of central line infections in children with short bowel syndrome. While ethanol locks have been used safely in children, there has been no published research to date that clearly shows it is of definite benefit in this group of patients.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 3 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >3 months
- •Intestinal failure patients
- •Silicone catheter for the administration of parenteral nutrition
排除标准
- •Age < 3 months
- •Weight < 5 kg
- •Documented allergy to ethanol
- •Evidence of tunnel site infection
- •Patients receiving continuous renal replacement therapy
- •Concomitant use of metronidazole
研究组 & 干预措施
Heparinized Saline
This group will maintain their central lines patent with heparinized saline.
干预措施: 70% ethanol (Drug)
Ethanol lock solution group
Administration of the 70% ethanol lock solution will occur between cycles of parenteral nutrition. Randomized lock solutions will be administered three days per week. When patients have completed their parenteral nutrition, their central venous catheters will be flushed with 5mL saline, per current standards
干预措施: 70% ethanol (Drug)
结局指标
主要结局
Catheter associated blood stream infection (CABSI).
时间窗: Number of infections reported per 1000 catheter days.
Published data in intensive care unit (ICU) patients with CABSI has noted that central venous catheter cultures had a specificity of 98% and a negative predictive value of 97%. In our study, we will define CABSI as a positive central venous catheter blood culture in the face of clinical signs of infection, when the catheter has been used in the last 48 hours prior to infection, and without other obvious source of infection. CABSI rate will be reported as number of infections per 1000 catheter days after 12 months of follow up.
次要结局
未报告次要终点
研究者
Tom Jaksic
W. Hardy Hendren Professor of Surgery, Harvard Medical School
Boston Children's Hospital