Sodium Bicarb Locks in Intestinal Failure
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Rate of catheter related bloodstream infections
研究概览
简要总结
We plan to include children with intestinal failure, a condition where the gut is not functioning properly, leading these children to need central venous catheters (line that goes through the skin into the blood stream) for nutritional support and hydration. Such patients have a very high risk for catheter infection. The study will include placing an agent (sodium bicarbonate) into the central catheter when the catheter is not in use. This is referred to as a lock. The lock would be used daily and removed when patients start their nutritional support and hydration through the catheter.
详细描述
Children with intestinal failure who rely on a silicone based central venous catheter for parenteral nutrition to provide nutritional support and hydration will be invited to participate in this study. The intervention will offer use of a specific catheter lock solution (8.4% sodium bicarbonate) when the catheter is not in use. This includes daily lock use with removal of the lock at end of dwell time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject fulfills diagnosis of intestinal failure with a central venous catheter in place used daily on outpatient basis for intravenous nutrition and /or intravenous hydration
- •Subject is less than 18 years of age at the time of study entry
- •Subject with history of at least 1 documented catheter related blood stream infection (verified by blood culture)
排除标准
- 未提供
研究组 & 干预措施
Baseline
Patient on heparin locks when off venous nutrition
干预措施: Sodium bicarb lock (Drug)
结局指标
主要结局
Rate of catheter related bloodstream infections
时间窗: Through study completion, an average of 1 year
Number of infections per 1000 catheter days
次要结局
未报告次要终点
研究者
Riad Rahhal
Clinical Professor
University of Iowa