Cardiac ARrest : Brain OXymetry Depending on HYpothermia Depth (CARBOXHYD)
Primary Purpose
Cardiac Arrest
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
therapeutic hypothermia at 32 ° C
therapeutic hypothermia at 34 ° C
Sponsored by
About this trial
This is an interventional prevention trial for Cardiac Arrest focused on measuring Cardiac arrest, Oxymetry, Hypothermia
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
Sites / Locations
- CH de Fréjus-Saint Raphael
- CHU de Nice - Hôpital Saint Roch
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
34°C
32°C
Arm Description
therapeutic hypothermia at 34 ° C
therapeutic hypothermia at 32 ° C
Outcomes
Primary Outcome Measures
Mesure of cerebral oximetry
During the first 48 hours of hospitalization, we will collect the cerebral oximetry values in the two cerebral hemispheres.
Secondary Outcome Measures
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.
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).
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)
Mesure of lactate
Lactate will be compared between patients with good (CPC 1-2) and poor (CPC 3-5) become throughout the study population
Full Information
NCT ID
NCT02052583
First Posted
November 20, 2013
Last Updated
March 21, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT02052583
Brief Title
Cardiac ARrest : Brain OXymetry Depending on HYpothermia Depth
Acronym
CARBOXHYD
Official Title
Evaluation de l'oxymétrie cérébrale à Deux Niveaux d'Hypothermie thérapeutique après arrêt Cardiaque Extra-hospitalier
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 28, 2014 (Actual)
Primary Completion Date
March 9, 2017 (Actual)
Study Completion Date
March 9, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
Cardiac arrest, Oxymetry, Hypothermia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
34°C
Arm Type
Experimental
Arm Description
therapeutic hypothermia at 34 ° C
Arm Title
32°C
Arm Type
Experimental
Arm Description
therapeutic hypothermia at 32 ° C
Intervention Type
Procedure
Intervention Name(s)
therapeutic hypothermia at 32 ° C
Intervention Type
Procedure
Intervention Name(s)
therapeutic hypothermia at 34 ° C
Primary Outcome Measure Information:
Title
Mesure of cerebral oximetry
Description
During the first 48 hours of hospitalization, we will collect the cerebral oximetry values in the two cerebral hemispheres.
Time Frame
8 times during the first 48 hours of hospitalization
Secondary Outcome Measure Information:
Title
The cerebral oximetry values (average of the two hemispheres) will be compared between patients with good and poor neurological outcome.
Description
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
Title
For each level of therapeutic hypothermia the cerebral oximetry values will be compared between patients with good and poor becoming
Description
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).
Time Frame
baseline, when target temperature is reached, 6 hours, 12 hours, 18 hours, 24 hours, when 37°C is reached
Title
Outcome of patients
Description
The outcome of patients (score 1-2 vs. CPC. 3-5 CPC) will be compared with the level of hypothermia (32 or 34 ° C)
Time Frame
6 months after hospitalization
Title
Mesure of lactate
Description
Lactate will be compared between patients with good (CPC 1-2) and poor (CPC 3-5) become throughout the study population
Time Frame
4 times during the first 48 hours of hospitalization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Christophe ORBAN, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Study Director
Facility Information:
Facility Name
CH de Fréjus-Saint Raphael
City
Fréjus
ZIP/Postal Code
83608
Country
France
Facility Name
CHU de Nice - Hôpital Saint Roch
City
Nice
ZIP/Postal Code
06000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Cardiac ARrest : Brain OXymetry Depending on HYpothermia Depth
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