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临床试验/NCT01495429
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

University of Michigan4 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2012年1月最近更新:
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适应症

试验速览

阶段
3 期
状态
已完成
入组人数
80
试验地点
4
主要终点
The composite of death or catheter related large vein thrombosis
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

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  • •expected to die or have care withdrawn prior to ICU day 7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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeffrey J Fletcher

Study PI

University of Michigan

研究点 (4)

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Peripherally Inserted Versus Centrally Inserted... | 临床试验