NCT01495429已完成3 期
A Phase III Study of Peripherally Inserted Versus Centrally Inserted Central Venous Catheters in the Neurological Intensive Care Unit
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The composite of death or catheter related large vein thrombosis
研究概览
简要总结
The investigators aim to compare the complications between centrally and peripherally inserted central venous catheters in neurological intensive care unit patients. The study hypothesis is that peripherally inserted catheters will have more cumulative complications due to venous thrombosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •all patients age > 18, admitted to the neurological ICU who are require a de novo central venous catheter as standard of care and in which a double lumen 5f PICC or CICVC (triple lumen, 7f) are acceptable for the indication.
- •the patients must be expected to survive and need a central venous catheter for at least 7 days.
排除标准
- •age < 18
- •expected to die or have care withdrawn prior to ICU day 7
- •requiring an emergent central venous catheter
- •suspected bacteremia
- •recent central venous catheter within the last 30 days
- •patients who are not a candidate for bedside placement of either a CICVC or PICC line
- •patients with renal insufficiency with creatinine level greater than 3.0 mg/dL (265.2 m mol/L) or who were undergoing hemodialysis
- •patients requiring a central venous catheter for prolonged antibiotic therapy\
- •patient who the treating clinician feels clearly needs one particular type of catheter over the other
研究组 & 干预措施
PICC line (Peripherally)
Experimental
placement of a picc line
干预措施: Central venous catheter (Procedure)
CICVC (central insertion)
Active Comparator
placement of a centrally inserted central venous catheter
干预措施: Central venous catheter (Procedure)
结局指标
主要结局
The composite of death or catheter related large vein thrombosis
时间窗: 15 days
次要结局
- Cumulative catheter related complications until discharge(30 days)
研究者
Jeffrey J Fletcher
Study PI
University of Michigan
研究点 (2)
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