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Cardiac ARrest : Brain OXymetry Depending on HYpothermia Depth

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02052583
Acronym
CARBOXHYD
Enrollment
44
Registered
2014-02-03
Start date
2014-03-28
Completion date
2017-03-09
Last updated
2023-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest

Keywords

Cardiac arrest, Oxymetry, Hypothermia

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.

Interventions

PROCEDUREtherapeutic hypothermia at 32 ° C
PROCEDUREtherapeutic hypothermia at 34 ° C

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mesure of cerebral oximetry8 times during the first 48 hours of hospitalizationDuring the first 48 hours of hospitalization, we will collect the cerebral oximetry values in the two cerebral hemispheres.

Secondary

MeasureTime frameDescription
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 hospitalizationThe 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 becomingbaseline, when target temperature is reached, 6 hours, 12 hours, 18 hours, 24 hours, when 37°C is reachedFor 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).
Outcome of patients6 months after hospitalizationThe 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 lactate4 times during the first 48 hours of hospitalizationLactate will be compared between patients with good (CPC 1-2) and poor (CPC 3-5) become throughout the study population

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026