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临床试验/NCT00940654
NCT00940654已完成不适用

The Fever and Antipyretic in Critically Illness Evaluation Study

Japanese Society of Intensive Care Medicine2 个研究点 分布在 2 个国家目标入组 1,426 人开始时间: 2009年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,426
试验地点
2
主要终点
28 days mortality

研究概览

简要总结

The purpose of this multination multicenter observational study is to determine the impact of fever and antipyretic on outcomes in critically ill patients.

详细描述

Fever is common in critically ill patients.Antipyretic therapy for fever is routinely performed in intensive care.There are studies to assess the relationship between fever and mortality in non-neurological ICU. However, all of them did not have any information of antipyretic therapy. There are two small, single center RCT, which suggested a potential risk for antipyretic therapy. Thus, a large RCT might be ethically difficult.

It is unfortunate that there is not enough information on how the investigators should control body temperature in non-neurological critically ill patients, because fever is a very common physiological abnormality in this cohort. From the beginning, it would, therefore, be desirable to understand several aspects of fever and antipyretic therapy in ICU patients, as 1)How often fever occurs in our ICUs, 2)To what degree fever is independently associated with mortality?, 3)How often antipyretic therapy is prescribed?, 4)How effectively antipyretic can decrease temperature?, 5)How different is lowering temperature with medications compared with cooling?, 6)To what degree antipyretic is independently associated with mortality?

Thus, the investigators plan to address these questions by conducting a multi-national multi-center prospective observational trial, named "The Fever and Antipyretic in Critically illness evaluation study" (The FACE study)

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult non-neurological critically ill patients (20 years old or older).
  • ICU patients expected to require intensive care for more than 48 hour.

排除标准

  • Patients with brain injury (suspected or proven)

结局指标

主要结局

28 days mortality

时间窗: 28days after ICU admission

次要结局

  • ICU free days at 28 days(28 days after ICU admission)
  • Hospital free days at 28 days(28 days)
  • Renal replacement therapy free days at 28 days(28 days at ICU admission)
  • Ventilator free days at 28 days(28 days at ICU admission)

研究者

发起方
Japanese Society of Intensive Care Medicine
申办方类型
Other

研究点 (2)

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