NCT01073098

Brief Summary

Out of hospital cardiac arrest is a major health problem. Prognosis is still poor even after return to spontaneous circulation. The pathophysiology of cardiac arrest implies ischemia-reperfusion and sepsis like syndrome. These phenomenons can lead to microvascular dysfunction explaining probably multi-organ failure after cardiac arrest. Few means allow the exploration of microvascular function in human. Muscle StO2 is a technique allowing the assessment of microvascular function non-invasively. The aim of this study is to evaluate muscle StO2 as a prognostic factor after out of hospital cardiac arrest.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2010

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

February 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 23, 2010

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 26, 2012

Status Verified

December 1, 2011

Enrollment Period

3 years

First QC Date

February 22, 2010

Last Update Submit

March 23, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reperfusion slope after vascular occlusion test. This parameter will be compared between survivors and non-survivors

    Four measurements : on admission, since the body core temperature reaches 34°, after 24 hours of hypothermia and 48 hours after admission to ICU

Secondary Outcomes (1)

  • Muscle StO2 during the first 2 days Lactatemia during the first 2 days These parameters will be compared between survivors and non-survivors

    Muscle StO2 will be monitored continuously during the first 2 days Lactatemia will be measured every 12 hours until normalization

Interventions

Reperfusion slope after vascular occlusion test

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Out of hospital cardiac arrest
  • Patient aged between 18 and 80 years
  • Having a Social Security System

You may not qualify if:

  • Pregnant women, lack of appropriate consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU de Nice -Hôpital l'Archet

Nice, 06000, France

RECRUITING

CHU de Nice Hôpital Saint Roch

Nice, 06000, France

RECRUITING

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Jean-Christophe ORBAN, MD

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Christophe ORBAN, MD

CONTACT

Carole ICHAI, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Department of Clinical Research and innovation (drc)

Study Record Dates

First Submitted

February 22, 2010

First Posted

February 23, 2010

Study Start

March 1, 2010

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

March 26, 2012

Record last verified: 2011-12

Locations