Cardiac ARrest : Brain OXymetry Depending on HYpothermia Depth

Cardiac Arrest Clinical Trial

— CARBOXHYD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02052583
• Other study ID #: 13-AOI-02
• Secondary ID: 2013-A01192-43
• Status: Completed
• Phase: N/A
• Start date: March 28, 2014
• Est. completion date: March 9, 2017

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 9, 2017
• Est. primary completion date: March 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

Procedure:
• therapeutic hypothermia at 32 ° C

• therapeutic hypothermia at 34 ° C

Locations

Country	Name	City	State
France	CH de Fréjus-Saint Raphael	Fréjus
France	CHU de Nice - Hôpital Saint Roch	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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