Cardiac ArrestCARBOXHYDNCT02052583
Cardiac ARrest : Brain OXymetry Depending on HYpothermia Depth
A study testing therapeutic hypothermia at 32 ° C and therapeutic hypothermia at 34 ° C in people with Cardiac Arrest, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
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 . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- therapeutic hypothermia at 32 ° C and therapeutic hypothermia at 34 ° C
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesFrance
- Study dates
- 28 Mar 2014to 9 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Major Patient protected by law
- Private person administrative or judicial freedom
- Neurological or traumatic cause of cardiac arrest
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
France2 sites
CH de Fréjus-Saint Raphael
Fréjus, 83608
CHU de Nice - Hôpital Saint Roch
Nice, 06000
About this study
Official title: 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.
- Conditions
- Cardiac Arrest
- Being tested
- therapeutic hypothermia at 32 ° C, therapeutic hypothermia at 34 ° C
- Keywords
- Cardiac arrest, Oxymetry, Hypothermia
- Medical subject headings
- Heart Arrest, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic hypothermia at 32 ° CProcedure or surgery
therapeutic hypothermia at 34 ° CProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 34°C | Experimental | therapeutic hypothermia at 34 ° C Receives: Procedure: therapeutic hypothermia at 34 ° C |
| 32°C | Experimental | therapeutic hypothermia at 32 ° C Receives: Procedure: therapeutic hypothermia at 32 ° C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mesure of cerebral oximetry
During the first 48 hours of hospitalization, we will collect the cerebral oximetry values in the two cerebral hemispheres.
Measured: 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.
The cerebral oximetry values (average of the two hemispheres) will be compared between patients with good and poor neurological outcome.
Measured: 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).
Measured: 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)
Measured: 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
Measured: 4 times during the first 48 hours of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study start28 Mar 2014
- Primary completion9 Mar 2017
- Study completion9 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Christophe ORBAN, MD, Study director, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02052583
- Sponsor's protocol ID
- 13-AOI-02
- Other IDs
- 2013-A01192-43
- Acronym
- CARBOXHYD
- Status last verified
- Aug 2018
- First submitted
- 20 Nov 2013
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation de l'oxymétrie cérébrale à Deux Niveaux d'Hypothermie thérapeutique après arrêt Cardiaque Extra-hospitalier
- ClinicalTrials.gov ID
- NCT02052583
- Acronym / sponsor ID
- CARBOXHYD / 13-AOI-02
- Conditions
- Cardiac Arrest
- Keywords
- Cardiac arrest, Oxymetry, Hypothermia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 28 Mar 2014 (actual)
- Primary completion
- 9 Mar 2017 (actual)
- Study completion
- 9 Mar 2017 (actual)
- First posted
- 3 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 34°C | Experimental | Procedure: therapeutic hypothermia at 34 ° Ctherapeutic hypothermia at 34 ° C |
| 32°C | Experimental | Procedure: therapeutic hypothermia at 32 ° Ctherapeutic hypothermia at 32 ° C |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- Major Patient protected by law
- Private person administrative or judicial freedom
- Neurological or traumatic cause of cardiac arrest
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| therapeutic hypothermia at 32 ° C | Procedure or surgery | 32°C |
| therapeutic hypothermia at 34 ° C | Procedure or surgery | 34°C |
Primary outcome
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.
4 secondary outcomes
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
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
Outcome of patients
Time frame: 6 months after hospitalization
Mesure of lactate
Time frame: 4 times during the first 48 hours of hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
Related trials for Cardiac Arrest
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The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
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Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
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The OXY-VENT Study
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Cardiac Arrest - Ultrasound Detection of Occult Perfusion
Cardiac Arrest, Out-Of-Hospital, Hypotension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Christophe ORBAN, MD study director
Centre Hospitalier Universitaire de Nice
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing therapeutic hypothermia at 32 ° C and therapeutic hypothermia at 34 ° C in people with Cardiac Arrest, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mesure of cerebral oximetry (time frame: 8 times during the first 48 hours of hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023; AzTrials last refreshed its copy on 1 Nov 2026.