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Completed

NCT Number: NCT02052583

Cardiac ARrest : Brain OXymetry Depending on HYpothermia Depth

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH de Fréjus-Saint Raphael, Fréjus, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

therapeutic hypothermia at 32 ° C

Procedure

therapeutic hypothermia at 34 ° C

Procedure

Primary outcomes

  1. Mesure of cerebral oximetry

    Time frame: 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 outcomes

  1. The cerebral oximetry values (average of the two hemispheres) will be compared between patients with good and poor neurological outcome.

    Time frame: 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.

  2. For each level of therapeutic hypothermia the cerebral oximetry values will be compared between patients with good and poor becoming

    Time frame: 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).

  3. Outcome of patients

    Time frame: 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)

  4. Mesure of lactate

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: CARBOXHYD

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Feb 3, 2014
Registry last updated
Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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