Cardiac ArrestHITUPPAC-BIONCT00886184
Intra-arrest Therapeutic Hypothermia in Prehospital Cardiac Arrest
A study testing Hypothermia. and No early hypothermia in people with Cardiac Arrest, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The aim is to precise the place of therapeutic hypothermia induced before Return of Spontaneous Circulation (ROSC) in pre hospital cardiac arrest. If we find a benefit in terms of biomarkers in inducing in early hypothermia compared to hypothermia induced only after arrival at the hospital, there will be arguments to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Hypothermia. and No early hypothermia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2009to Aug 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pre hospital cardiac arrest
Who cannot join
- under 18 years old
- pregnancy or breastfeeding women
- patient under guardianship.
- not beneficing a social health care system.
- cardiac arrest of traumatic origin
- patients with an initial body temperature under 34° C
- cardiac arrests for which resuscitation maneuvers seem unjustified (DNR criteria)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intra-arrest Therapeutic Hypothermia in Prehospital Cardiac Arrest. Impact on Biomarker of Brain Damage.
The aim is to precise the place of therapeutic hypothermia induced before Return of Spontaneous Circulation (ROSC) in pre hospital cardiac arrest. If we find a benefit in terms of biomarkers in inducing in early hypothermia compared to hypothermia induced only after arrival at the hospital, there will be arguments to develop a higher scale study, allowing to prove benefits in terms of survival and neurological status.
Read the detailed description
Principal aim : prove the efficiency of early therapeutic hypothermia induced during ischemia in pre hospital cardiac arrest by a reduction of brain damage biomarkers.
Secondary aim: prove the efficiency of early therapeutic induced hypothermia in the reduction of pro-inflammatory cytokines secretion. Determine the number of ROSC, patients survival, neurological status 48 hours after cardiac arrest (GCS) and when leaving the hospital, impact following initial cardiac rhythm and the cooling rate of early therapeutic induced hypothermia.
- Conditions
- Cardiac Arrest
- Being tested
- Hypothermia., No early hypothermia
- Keywords
- Hypothermia, Cardiac arrest, Biomarkers, Pre hospital cardiac arrest
- 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.
Hypothermia.Procedure or surgery
Induction of pre hospital therapeutic hypothermia.
No early hypothermiaProcedure or surgery
Induction of therapeutic hypothermia only once arrived at hospital.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Induction of pre hospital early hypothermia in patients having a cardiac . Receives: Procedure: Hypothermia. |
| 2 | Active comparator | Induction of hypothermia only at hospital arrival. Receives: Procedure: No early hypothermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prove efficacy of early induced hypothermia during ischemia in pre hospital cardiac arrest by a reduction of brain damage biomarkers.
Measured: 72 hours
Secondary outcomes (6)
Prove the efficacy of early therapeutic induced hypothermia in the reduction of pro-inflammatory cytokines secretion.
Measured: 72 hours
Determine the number of Return of Spontaneous Circulation (ROSC), patients survival.
Measured: 72 hours
Determine neurological status 48 hours after cardiac arrest (GCS)
Measured: 48 hours
Determine impact following initial cardiac rhythm.
Measured: 72 hours
Determine the cooling rate of early therapeutic induced hypothermia.
Measured: 72 hours
Determine neurological status when leaving hospital (or 28 days if not applicable) (CPC)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2009 (estimated)
- Study startFeb 2009
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume DEBATY, MD, Principal investigator, Emergency department - Mobile Intensive Care Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886184
- Sponsor's protocol ID
- 0821
- Other IDs
- 2008-A01488-47
- Acronym
- HITUPPAC-BIO
- Status last verified
- Jan 2013
- First submitted
- 20 Apr 2009
- Last updated
- 30 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ferreira Da Silva IR, Frontera JA. Targeted temperature management in survivors of cardiac arrest. Cardiol Clin. 2013 Nov;31(4):637-55, ix. doi: 10.1016/j.ccl.2013.07.010.
PubMed 24188226
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-arrest Therapeutic Hypothermia in Prehospital Cardiac Arrest. Impact on Biomarker of Brain Damage.
- ClinicalTrials.gov ID
- NCT00886184
- Acronym / sponsor ID
- HITUPPAC-BIO / 0821
- Conditions
- Cardiac Arrest
- Keywords
- Hypothermia, Cardiac arrest, Biomarkers, Pre hospital cardiac arrest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 22 Apr 2009 (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.
The aim is to precise the place of therapeutic hypothermia induced before Return of Spontaneous Circulation (ROSC) in pre hospital cardiac arrest. If we find a benefit in terms of biomarkers in inducing in early hypothermia compared to hypothermia induced only after arrival at the hospital, there will be arguments to develop a higher scale study, allowing to prove benefits in terms of survival and neurological status.
Detailed description
Principal aim : prove the efficiency of early therapeutic hypothermia induced during ischemia in pre hospital cardiac arrest by a reduction of brain damage biomarkers.
Secondary aim: prove the efficiency of early therapeutic induced hypothermia in the reduction of pro-inflammatory cytokines secretion. Determine the number of ROSC, patients survival, neurological status 48 hours after cardiac arrest (GCS) and when leaving the hospital, impact following initial cardiac rhythm and the cooling rate of early therapeutic induced hypothermia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Hypothermia.Induction of pre hospital early hypothermia in patients having a cardiac . |
| 2 | Active comparator | Procedure: No early hypothermiaInduction of hypothermia only at hospital arrival. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- pre hospital cardiac arrest
Key exclusion criteria (7 listed)
- under 18 years old
- pregnancy or breastfeeding women
- patient under guardianship.
- not beneficing a social health care system.
- cardiac arrest of traumatic origin
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 |
|---|---|---|
| Hypothermia.Induction of pre hospital therapeutic hypothermia. | Procedure or surgery | 1 |
| No early hypothermiaInduction of therapeutic hypothermia only once arrived at hospital. | Procedure or surgery | 2 |
Primary outcome
Prove efficacy of early induced hypothermia during ischemia in pre hospital cardiac arrest by a reduction of brain damage biomarkers.
Time frame: 72 hours
6 secondary outcomes
Prove the efficacy of early therapeutic induced hypothermia in the reduction of pro-inflammatory cytokines secretion.
Time frame: 72 hours
Determine the number of Return of Spontaneous Circulation (ROSC), patients survival.
Time frame: 72 hours
Determine neurological status 48 hours after cardiac arrest (GCS)
Time frame: 48 hours
Determine impact following initial cardiac rhythm.
Time frame: 72 hours
Determine the cooling rate of early therapeutic induced hypothermia.
Time frame: 72 hours
Determine neurological status when leaving hospital (or 28 days if not applicable) (CPC)
Time frame: 28 days
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 30 Jan 2013.
- Derived from this study: PubMed 24188226Ferreira Da Silva IR, Frontera JA. Targeted temperature management in survivors of cardiac arrest. Cardiol Clin. 2013 Nov;31(4):637-55, ix. doi: 10.1016/j.ccl.2013.07.010.
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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.
Guillaume DEBATY, MD principal investigator
Emergency department - Mobile Intensive Care Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypothermia. and No early hypothermia in people with Cardiac Arrest, run by University Hospital, Grenoble at 1 site 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 1 inclusion and 7 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 30 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Prove efficacy of early induced hypothermia during ischemia in pre hospital cardiac arrest by a reduction of brain damage biomarkers. (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00886184, which also lists 1 linked publication.
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 30 Jan 2013.