跳至主要内容
临床试验/NCT03648021
NCT03648021已完成4 期

NEUROTHERM: The Effect of Paracetamol on Brain Temperature in Acute Brain Injury in a Neuro Critical Care Unit: A Randomized Controlled Trial

Fondation Ophtalmologique Adolphe de Rothschild1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年5月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
100
试验地点
1
主要终点
Comparison of mean brain temperature measured between H0 and H6 following administration of treatment between the two groups (the group treated with paracetamol and the placebo group)

研究概览

简要总结

The main objective of this study is to compare the effect of intravenous paracetamol administration on mean brain temperature (measured between H0 and H6) in patients with cerebral hyperthermia versus placebo.

The investigators will measure brain temperature using a thermistor that will be connected to the intracranial pressure transducer.

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
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

paracetamol (acetaminophen)

Active Comparator

patient will receive1 gramme of paracetamol intravenously

干预措施: Paracetamol (Drug)

Placebo

Placebo Comparator

patient will receive 100 ml of chlorure de sodium 0,9% intravenously

干预措施: Placebo (Drug)

结局指标

主要结局

Comparison of mean brain temperature measured between H0 and H6 following administration of treatment between the two groups (the group treated with paracetamol and the placebo group)

时间窗: Six hours after administration of treatment

measurement of intracerebral temperature in degrees

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (1)

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