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

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ClinicalTrials.gov Identifier: NCT01073098
Recruitment Status : Unknown
Verified December 2011 by Department of Clinical Research and Innovation, Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Recruiting
First Posted : February 23, 2010
Last Update Posted : March 26, 2012
Sponsor:
Collaborator:
Centre Hospitalier Universitaire de Nice
Information provided by (Responsible Party):
Department of Clinical Research and Innovation, Centre Hospitalier Universitaire de Nice

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.

Condition or disease Intervention/treatment
Cardiac Arrest Other: Vascular occlusion test

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Evaluation of Muscle StO2 as a Prognostic Factor After Out of Hospital Cardiac Arrest
Study Start Date : March 2010
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Other: Vascular occlusion test
    Reperfusion slope after vascular occlusion test


Primary Outcome Measures :
  1. Reperfusion slope after vascular occlusion test. This parameter will be compared between survivors and non-survivors [ Time Frame: Four measurements : on admission, since the body core temperature reaches 34°, after 24 hours of hypothermia and 48 hours after admission to ICU ]

Secondary Outcome Measures :
  1. Muscle StO2 during the first 2 days Lactatemia during the first 2 days These parameters will be compared between survivors and non-survivors [ Time Frame: Muscle StO2 will be monitored continuously during the first 2 days Lactatemia will be measured every 12 hours until normalization ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01073098


Contacts
Contact: Jean-Christophe ORBAN, MD +33 4 92 03 33 00 orban.j@chu-nice.fr
Contact: Carole ICHAI, MD, PhD +33 4 92 03 33 00 ichai.c@chu-nice.fr

Locations
France
CHU de Nice -Hôpital l'Archet Recruiting
Nice, France, 06000
Contact: Jean-Christophe ORBAN, MD    00 33 4 92 03 33 00    orban.j@chu-nice.fr   
Sub-Investigator: Hervé Hyvernat, MD         
Sub-Investigator: Ludovic Grech, MD         
Sub-Investigator: Jean Dellamonica, MD         
CHU de Nice Hôpital Saint Roch Recruiting
Nice, France, 06000
Contact: Jean-Christophe ORBAN, MD    +33 4 92 03 33 00    orban.j@chu-nice.fr   
Contact: Audrey RENARD, MD    +33 4 92 03 33 00    audrey.27.03@free.fr   
Principal Investigator: Jean-Christophe ORBAN, MD         
Sub-Investigator: Carole ICHAI, MD, PhD         
Sub-Investigator: Hervé QUINTARD, MD         
Sponsors and Collaborators
Department of Clinical Research and Innovation
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Jean-Christophe ORBAN, MD CHU de Nice

Responsible Party: Department of Clinical Research and Innovation, Department of Clinical Research and innovation (drc), Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01073098     History of Changes
Other Study ID Numbers: 2009-A01187-50
First Posted: February 23, 2010    Key Record Dates
Last Update Posted: March 26, 2012
Last Verified: December 2011

Additional relevant MeSH terms:
Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases