Heart ArrestNCT00888966
Oxidative Stress and Cardiac Arrest
An observational study of Heart Arrest, run by Institut d'Anesthesiologie des Alpes Maritimes at 1 site in France.
Trial summary
Cardiac arrest is a major health problem reaching 375000 cases in Europe each year. Only 5 to 31 % survive after an out of hospital cardiac arrest (OHCA). The main complication after OHCA is the anoxic encephalopathy. Recently mild hypothermia has shown a beneficial effect on survival. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Arrest
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2006to Dec 2010
- Phase
- Observational
- 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
Study population: community sample
Who may be able to join
- Out of hospital cardiac arrest
Who cannot join
- refractory shock
- moribund patient
- resuscitation > 60 minutes
- hypothermia < 30 degrees
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Oxidative Stress After Out of Hospital Cardiac Arrest Treated With Moderate Hypothermia
Cardiac arrest is a major health problem reaching 375000 cases in Europe each year. Only 5 to 31 % survive after an out of hospital cardiac arrest (OHCA). The main complication after OHCA is the anoxic encephalopathy. Recently mild hypothermia has shown a beneficial effect on survival. But the mechanisms underlying these therapy are not clear.
Cardiac arrest is an example of ischemia reperfusion of the entire body. And it is well demonstrated that reperfusion generates an oxidative stress. But it has never been shown in a clinical setting.
The aim of the study is to evaluate oxidative stress after out of hospital cardiac arrest treated with mild hypothermia.
- Conditions
- Heart Arrest
- Keywords
- heart arrest, oxidative stress, lactic acid, outcome
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Out of hospital cardiac arrest | Out of hospital cardiac patients successfully resuscitated and admitted to ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative stress markers and antioxidants after out of hospital cardiac arrest
Measured: 4 days
Secondary outcomes (2)
Lactate after out of hospital cardiac arrest
Measured: 4 days
Outcome after out of hospital cardiac arrest
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2009 (estimated)
- Study startApr 2006
- Primary completionJun 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut d'Anesthesiologie des Alpes Maritimes
- Sponsor type
- University, hospital or other
- Investigators
- Carole Ichai, MD, PhD, Study chair, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888966
- Sponsor's protocol ID
- IAAM 2009-2
- Status last verified
- Jun 2011
- First submitted
- 25 Apr 2009
- Last updated
- 4 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oxidative Stress After Out of Hospital Cardiac Arrest Treated With Moderate Hypothermia
- ClinicalTrials.gov ID
- NCT00888966
- Acronym / sponsor ID
- IAAM 2009-2
- Conditions
- Heart Arrest
- Keywords
- heart arrest, oxidative stress, lactic acid, outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Institut d'Anesthesiologie des Alpes MaritimesUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Jun 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 28 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.
Cardiac arrest is a major health problem reaching 375000 cases in Europe each year. Only 5 to 31 % survive after an out of hospital cardiac arrest (OHCA). The main complication after OHCA is the anoxic encephalopathy. Recently mild hypothermia has shown a beneficial effect on survival. But the mechanisms underlying these therapy are not clear.
Cardiac arrest is an example of ischemia reperfusion of the entire body. And it is well demonstrated that reperfusion generates an oxidative stress. But it has never been shown in a clinical setting.
The aim of the study is to evaluate oxidative stress after out of hospital cardiac arrest treated with mild hypothermia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Out of hospital cardiac arrest | – | –Out of hospital cardiac patients successfully resuscitated and admitted to ICU |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- community sample
Key inclusion criteria (1 listed)
- Out of hospital cardiac arrest
Key exclusion criteria (4 listed)
- refractory shock
- moribund patient
- resuscitation > 60 minutes
- hypothermia < 30 degrees
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oxidative stress markers and antioxidants after out of hospital cardiac arrest
Time frame: 4 days
2 secondary outcomes
Lactate after out of hospital cardiac arrest
Time frame: 4 days
Outcome after out of hospital cardiac arrest
Time frame: 6 months
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 4 Jul 2011.
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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.
Carole Ichai, MD, PhD study chair
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Arrest, run by Institut d'Anesthesiologie des Alpes Maritimes 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 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 4 Jul 2011. 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?
Oxidative stress markers and antioxidants after out of hospital cardiac arrest (time frame: 4 days). 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 4 Jul 2011.