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临床试验/NCT00122707
NCT00122707已完成不适用

Randomized Controlled Trial of Mechanical and Infectious Complications of Central Versus Peripheral Venous Catheters in ICU Patients

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2004年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
1
主要终点
failure to insert line

研究概览

简要总结

The purpose of this study is to compare the mechanical and infectious complications of peripheral versus central venous catheters in critically ill patients. Group allocation will be performed by randomization.

详细描述

Critically ill patients require intravenous administration of fluids and drugs. This can be achieved via peripheral or central catheters. Each device is associated with both mechanical and infectious complications. Complications associated with central lines are judged to be more severe. Some patients actually require the insertion of a central line due to the venous toxicity of the drugs or to the necessity of making sure that the infusion is regularly administered (example: high dose catecholamine infusion). Some physicians believe that most Intensive Care Unit (ICU) patients should have a central venous line inserted, whereas others feel that some patients may receive active drugs via a peripheral line in selected instances. No study prospectively compared the feasibility, merits and complications of the two possibilities (i.e., central or peripheral venous line). This study includes patients that can receive either a central or a peripheral line (see inclusion criteria): mainly patients receiving large amounts of fluid, moderate doses of catecholamines or of drugs that may cause venous injury. Patients are randomized to receive either a peripheral or a central venous catheter. Endpoints are the rate of mechanical complications (difficulty in inserting the line, need for repeat insertion attempts, occurrence of arterial puncture, occurrence of pneumothorax) and of infectious complications (local catheter infection or catheter-related bloodstream infection).

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

  • •Patients requiring low to moderate doses of continuous catecholamine administration in the ICU
  • •Patients with 2 failed attempts at inserting a peripheral line
  • •Patients who require daily change of lines

排除标准

  • •Patients aged less than 18 years
  • •Pregnancy
  • •Absolute necessity of central venous access (refractory shock/high dose catecholamine infusion)

结局指标

主要结局

failure to insert line

mechanical complications of intravenous line insertion

infectious complications of intravenous lines

次要结局

  • number of cross-overs (due to impossibility of inserting/maintaining a peripheral line)

研究者

申办方类型
Other

研究点 (1)

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