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Oxidative Stress and Cardiac Arrest

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ClinicalTrials.gov Identifier: NCT00888966
Recruitment Status : Completed
First Posted : April 28, 2009
Last Update Posted : July 4, 2011
Sponsor:
Information provided by:
Institut d'Anesthesiologie des Alpes Maritimes

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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. 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.


Condition or disease
Heart Arrest

Study Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Oxidative Stress After Out of Hospital Cardiac Arrest Treated With Moderate Hypothermia
Study Start Date : April 2006
Actual Primary Completion Date : June 2010
Actual Study Completion Date : December 2010

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U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Out of hospital cardiac arrest
Out of hospital cardiac patients successfully resuscitated and admitted to ICU


Outcome Measures
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Primary Outcome Measures :
  1. Oxidative stress markers and antioxidants after out of hospital cardiac arrest [ Time Frame: 4 days ]

Secondary Outcome Measures :
  1. Lactate after out of hospital cardiac arrest [ Time Frame: 4 days ]
  2. Outcome after out of hospital cardiac arrest [ Time Frame: 6 months ]

Biospecimen Retention:   Samples Without DNA
Plasma

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
community sample
Criteria

Inclusion Criteria:

  • Out of hospital cardiac arrest

Exclusion Criteria:

  • refractory shock
  • moribund patient
  • resuscitation > 60 minutes
  • hypothermia < 30 degrees
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00888966


Locations
France
CHU de Nice
Nice, France, 06003
Sponsors and Collaborators
Institut d'Anesthesiologie des Alpes Maritimes
Investigators
Study Chair: Carole Ichai, MD, PhD CHU de Nice
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Orban MD, CHU de Nice
ClinicalTrials.gov Identifier: NCT00888966     History of Changes
Other Study ID Numbers: IAAM 2009-2
First Posted: April 28, 2009    Key Record Dates
Last Update Posted: July 4, 2011
Last Verified: June 2011

Keywords provided by Institut d'Anesthesiologie des Alpes Maritimes:
heart arrest
oxidative stress
lactic acid
outcome

Additional relevant MeSH terms:
Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases