Clinical trial NCT02052583: Cardiac ARrest : Brain OXymetry Depending on HYpothermia Depth
Official title: Evaluation de l'oxymétrie cérébrale à Deux Niveaux d'Hypothermie thérapeutique après arrêt Cardiaque Extra-hospitalier
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Keywords: Cardiac arrest
Oxymetry
Hypothermia
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2014-02-03
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Mesure of cerebral oximetry
timeFrame: 8 times during the first 48 hours of hospitalization
Secondary outcomes:
measure: The cerebral oximetry values (average of the two hemispheres) will be compared between patients with good and poor neurological outcome.
timeFrame: 8 times during the first 48 hours of hospitalization
measure: For each level of therapeutic hypothermia the cerebral oximetry values will be compared between patients with good and poor becoming
timeFrame: baseline, when target temperature is reached, 6 hours, 12 hours, 18 hours, 24 hours, when 37°C is reached
measure: Outcome of patients
timeFrame: 6 months after hospitalization
measure: Mesure of lactate
timeFrame: 4 times during the first 48 hours of hospitalization
Other outcomes:
Locations:
city: Fréjus
country: France
facility: CH de Fréjus-Saint Raphael
city: Nice
country: France
facility: CHU de Nice - Hôpital Saint Roch
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Jean-Christophe ORBAN, MD
role: STUDY_DIRECTOR
References: