Cardiac ARrest : Brain OXymetry Depending on HYpothermia Depth

NCT02052583 | Completed

• 2 other identifiers: 13-AOI-022013-A01192-43
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiac Arrest

Keywords

Cardiac arrest; Oxymetry; Hypothermia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  baseline, when target temperature is reached, 6 hours, 12 hours, 18 hours, 24 hours, when 37°C is reached

• Outcome of patients

  6 months after hospitalization

• Mesure of lactate

  4 times during the first 48 hours of hospitalization

Study Arms (2)

34°C

EXPERIMENTAL

therapeutic hypothermia at 34 ° C

Procedure: therapeutic hypothermia at 34 ° C

32°C

EXPERIMENTAL

therapeutic hypothermia at 32 ° C

Procedure: therapeutic hypothermia at 32 ° C

Interventions

therapeutic hypothermia at 32 ° C PROCEDURE

32°C

therapeutic hypothermia at 34 ° C PROCEDURE

34°C

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Major Patient protected by law
• Private person administrative or judicial freedom
• Neurological or traumatic cause of cardiac arrest
• Pregnancy

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (2)

CH de Fréjus-Saint Raphael

Fréjus, 83608, France

Location

CHU de Nice - Hôpital Saint Roch

Nice, 06000, France

Location

MeSH Terms

Conditions

Heart Arrest; Hypothermia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Christophe ORBAN, MD

  Centre Hospitalier Universitaire de Nice

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2013
• First Posted: February 3, 2014
• Study Start: March 28, 2014
• Primary Completion: March 9, 2017
• Study Completion: March 9, 2017
• Last Updated: March 22, 2023

Record last verified: 2018-08

Locations

FR (2)