Oxidative Stress and Cardiac Arrest

Heart Arrest Clinical Trial

Official title:

Evaluation of Oxidative Stress After Out of Hospital Cardiac Arrest Treated With Moderate Hypothermia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00888966
• Other study ID #: IAAM 2009-2
• Status: Completed
• Phase: N/A
• First received: April 25, 2009
• Last updated: June 30, 2011
• Start date: April 2006
• Est. completion date: December 2010

Study information

• Verified date: June 2011
• Source: Institut d'Anesthesiologie des Alpes Maritimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Out of hospital cardiac arrest

Exclusion Criteria:

• refractory shock

• moribund patient

• resuscitation > 60 minutes

• hypothermia < 30 degrees

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Locations

Country	Name	City	State
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Institut d'Anesthesiologie des Alpes Maritimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxidative stress markers and antioxidants after out of hospital cardiac arrest		4 days	No
Secondary	Lactate after out of hospital cardiac arrest		4 days	No
Secondary	Outcome after out of hospital cardiac arrest		6 months	No