NCT00888966

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 28, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

July 4, 2011

Status Verified

June 1, 2011

Enrollment Period

4.2 years

First QC Date

April 25, 2009

Last Update Submit

June 30, 2011

Conditions

Heart Arrest

Keywords

heart arrestoxidative stresslactic acidoutcome

Outcome Measures

Primary Outcomes (1)

  • Oxidative stress markers and antioxidants after out of hospital cardiac arrest

    4 days

Secondary Outcomes (2)

  • Lactate after out of hospital cardiac arrest

    4 days

  • Outcome after out of hospital cardiac arrest

    6 months

Study Arms (1)

Out of hospital cardiac arrest

Out of hospital cardiac patients successfully resuscitated and admitted to ICU

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

community sample

You may qualify if:

  • Out of hospital cardiac arrest

You may not qualify if:

  • refractory shock
  • moribund patient
  • resuscitation \> 60 minutes
  • hypothermia \< 30 degrees

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice

Nice, 06003, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Carole Ichai, MD, PhD

    Centre Hospitalier Universitaire de Nice

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 25, 2009

First Posted

April 28, 2009

Study Start

April 1, 2006

Primary Completion

June 1, 2010

Study Completion

December 1, 2010

Last Updated

July 4, 2011

Record last verified: 2011-06

Locations

FR(1)