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Evaluation of Muscle StO2 as a Prognostic Factor After Out of Hospital Cardiac Arrest

NCT ID: NCT01073098

Last Updated: 2012-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-03-31

Brief Summary

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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.

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Detailed Description

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Out of hospital cardiac arrest is a major health problem accounting for 375000 deaths each year in Europe. Even after return to spontaneous circulation, survival is poor because of complications such as post-anoxic encephalopathy and multi-organ failure. The pathophysiology of cardiac arrest implies ischemia-reperfusion and sepsis like syndrome. These conditions are frequently associated with microvascular dysfunction that can be the "motor" of multi-organ failure. Few means allow the exploration of microvascular function in human. Recently, StO2, a non-invasive technique assessing microvascular function has been described. This technique measures the tissular saturation of a muscle using the near-infrared spectroscopy technique. It has been described to be a good prognostic factor during haemorrhagic shock state. Dynamic parameters such as reperfusion slope allow discriminating between survivors and survivors after severe sepsis. This dynamic test assesses the microvasculature recruitment that could be a marker of better prognosis. The aim of this study is to evaluate muscle StO2 as a prognostic factor after out of hospital cardiac arrest.

Conditions

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Cardiac Arrest

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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Vascular occlusion test

Reperfusion slope after vascular occlusion test

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnant women, lack of appropriate consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role collaborator

Department of Clinical Research and Innovation

OTHER

Sponsor Role lead

Responsible Party

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Department of Clinical Research and Innovation

Department of Clinical Research and innovation (drc)

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jean-Christophe ORBAN, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

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CHU de Nice -Hôpital l'Archet

Nice, , France

Site Status RECRUITING

CHU de Nice Hôpital Saint Roch

Nice, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jean-Christophe ORBAN, MD

Role: CONTACT

[email protected]
+33 4 92 03 33 00

Carole ICHAI, MD, PhD

Role: CONTACT

[email protected]
+33 4 92 03 33 00

Facility Contacts

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Jean-Christophe ORBAN, MD

Role: primary

[email protected]
00 33 4 92 03 33 00

Jean-Christophe ORBAN, MD

Role: primary

[email protected]
+33 4 92 03 33 00

Audrey RENARD, MD

Role: backup

[email protected]
+33 4 92 03 33 00

Other Identifiers

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2009-A01187-50

Identifier Type: -

Identifier Source: org_study_id

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