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Oxidative Stress and Cardiac Arrest

This study has been completed.
Sponsor:
Information provided by:
Institut d'Anesthesiologie des Alpes Maritimes
ClinicalTrials.gov Identifier:
NCT00888966
First received: April 25, 2009
Last updated: June 30, 2011
Last verified: June 2011
History of Changes
  Purpose

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
Heart Arrest

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Oxidative Stress After Out of Hospital Cardiac Arrest Treated With Moderate Hypothermia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut d'Anesthesiologie des Alpes Maritimes:

Primary Outcome Measures:
  • Oxidative stress markers and antioxidants after out of hospital cardiac arrest [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lactate after out of hospital cardiac arrest [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • Outcome after out of hospital cardiac arrest [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA
Plasma

Estimated Enrollment: 40
Study Start Date: April 2006
Study Completion Date: December 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Out of hospital cardiac arrest
Out of hospital cardiac patients successfully resuscitated and admitted to ICU

  Eligibility
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Responsible Party: Orban MD, CHU de Nice
ClinicalTrials.gov Identifier: NCT00888966     History of Changes
Other Study ID Numbers: IAAM 2009-2 
Study First Received: April 25, 2009
Last Updated: June 30, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on September 29, 2016