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临床试验/NCT02052583
NCT02052583已完成不适用

Evaluation de l'oxymétrie cérébrale à Deux Niveaux d'Hypothermie thérapeutique après arrêt Cardiaque Extra-hospitalier

Centre Hospitalier Universitaire de Nice4 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2014年3月28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
44
试验地点
4
主要终点
Mesure of cerebral oximetry

研究概览

简要总结

Cardiac arrest is a major public health problem, with 700 000 cases per year , and a survival ranging from 4 to 33%. The post- anoxic encephalopathy remains the most serious complication with only a third of survivors . It is due to a series of phenomena involving microcirculation disorders . Cerebral oximetry is a new technique to evaluate the microcirculatory status . To this day it is used in cardiovascular surgery at risk of cerebral hypoperfusion where desaturation of cerebral oximetry is synonymous with ischemia and microcirculatory disorders. Therapeutic hypothermia is the only treatment improves the outcome of patients after extra- hospital cardiac arrest resuscitation . Its mechanisms of action seem to change all the phenomena responsible for microcirculatory reperfusion disorders . Currently it is recommended to practice hypothermia between 32 and 34 ° C. However, a recent study suggests a superiority of hypothermia at 32 ° C rather than 34 ° C.

The hypothesis of this study is that cerebral oximetry value will be different in patients subjected to two different levels of therapeutic hypothermia in the aftermath of an extra- hospital cardiac arrest. These data allow a better understanding of the mechanisms underlying the benefit of this technique.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient presented with an extra-hospital cardiac arrest resuscitation and to benefit from therapeutic hypothermia using a servo system to its temperature (CoolGard 3000 ® system)
  • Age> 18 years and <80 years

排除标准

  • Major Patient protected by law
  • Private person administrative or judicial freedom
  • Neurological or traumatic cause of cardiac arrest
  • Pregnancy

结局指标

主要结局

Mesure of cerebral oximetry

时间窗: 8 times during the first 48 hours of hospitalization

During the first 48 hours of hospitalization, we will collect the cerebral oximetry values in the two cerebral hemispheres.

次要结局

  • Outcome of patients(6 months after hospitalization)
  • Mesure of lactate(4 times during the first 48 hours of hospitalization)
  • The cerebral oximetry values (average of the two hemispheres) will be compared between patients with good and poor neurological outcome.(8 times during the first 48 hours of hospitalization)
  • For each level of therapeutic hypothermia the cerebral oximetry values will be compared between patients with good and poor becoming(baseline, when target temperature is reached, 6 hours, 12 hours, 18 hours, 24 hours, when 37°C is reached)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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