Cardiac ARrest : Brain OXymetry Depending on HYpothermia Depth (CARBOXHYD)

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrest
• Intervention / Treatment: Procedure: therapeutic hypothermia at 34 ° C; Procedure: therapeutic hypothermia at 32 ° C

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Fréjus, France, 83608
    • CH de Fréjus-Saint Raphael
  • Nice, France, 06000
    • CHU de Nice - Hôpital Saint Roch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 34°C; therapeutic hypothermia at 34 ° C	Procedure: therapeutic hypothermia at 34 ° C
Experimental: 32°C; therapeutic hypothermia at 32 ° C	Procedure: therapeutic hypothermia at 32 ° C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mesure of cerebral oximetry	During the first 48 hours of hospitalization, we will collect the cerebral oximetry values in the two cerebral hemispheres.	8 times during the first 48 hours of hospitalization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The cerebral oximetry values (average of the two hemispheres) will be compared between patients with good and poor neurological outcome.	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	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).	baseline, when target temperature is reached, 6 hours, 12 hours, 18 hours, 24 hours, when 37°C is reached
Outcome of patients	The outcome of patients (score 1-2 vs. CPC. 3-5 CPC) will be compared with the level of hypothermia (32 or 34 ° C)	6 months after hospitalization
Mesure of lactate	Lactate will be compared between patients with good (CPC 1-2) and poor (CPC 3-5) become throughout the study population	4 times during the first 48 hours of hospitalization

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Study Director: Jean-Christophe ORBAN, MD, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2014
• Primary Completion (Actual): March 9, 2017
• Study Completion (Actual): March 9, 2017

Study Registration Dates

• First Submitted: November 20, 2013
• First Submitted That Met QC Criteria: January 31, 2014
• First Posted (Estimate): February 3, 2014

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Cardiac arrest; Hypothermia; Oxymetry
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: 13-AOI-02; 2013-A01192-43 (Other Identifier: ANSM)