Cardiac ARrest : Brain OXymetry Depending on HYpothermia Depth
- Conditions
- Cardiac Arrest
- Interventions
- Procedure: therapeutic hypothermia at 34 ° CProcedure: therapeutic hypothermia at 32 ° C
- Registration Number
- NCT02052583
- Lead Sponsor
- Centre Hospitalier Universitaire de Nice
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- 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
- Major Patient protected by law
- Private person administrative or judicial freedom
- Neurological or traumatic cause of cardiac arrest
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 34°C therapeutic hypothermia at 34 ° C therapeutic hypothermia at 34 ° C 32°C therapeutic hypothermia at 32 ° C therapeutic hypothermia at 32 ° C
- Primary Outcome Measures
Name Time Method Mesure of cerebral oximetry 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.
- Secondary Outcome Measures
Name Time Method Outcome of patients 6 months after hospitalization The outcome of patients (score 1-2 vs. CPC. 3-5 CPC) will be compared with the level of hypothermia (32 or 34 ° C)
Mesure of lactate 4 times during the first 48 hours of hospitalization Lactate will be compared between patients with good (CPC 1-2) and poor (CPC 3-5) become throughout the study population
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 The cerebral oximetry values (average of the two hemispheres) will be compared between patients with good and poor neurological outcome.
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 For each level of therapeutic hypothermia (32 or 34 ° C), the cerebral oximetry values (average of the two hemispheres) will be compared between patients with good and poor becoming according to the CPC score (CPC = 1 become good score - 2 and bad become CPC = 3-5).
Trial Locations
- Locations (2)
CHU de Nice - Hôpital Saint Roch
🇫🇷Nice, France
CH de Fréjus-Saint Raphael
🇫🇷Fréjus, France