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

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.

Study Overview

• Status: Unknown
• Conditions: Cardiac Arrest
• Intervention / Treatment: 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
• Enrollment (Anticipated): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nice, France, 06000
    • Recruiting
    • CHU de Nice -Hôpital l'Archet
    • Contact: Jean-Christophe ORBAN, MD; Phone Number: 00 33 4 92 03 33 00; Email: orban.j@chu-nice.fr
    • Sub-Investigator: Hervé Hyvernat, MD
    • Sub-Investigator: Ludovic Grech, MD
    • Sub-Investigator: Jean Dellamonica, MD
  • Nice, France, 06000
    • Recruiting
    • CHU de Nice Hôpital Saint Roch
    • Contact: Jean-Christophe ORBAN, MD; Phone Number: +33 4 92 03 33 00; Email: orban.j@chu-nice.fr
    • Contact: Audrey RENARD, MD; Phone Number: +33 4 92 03 33 00; Email: audrey.27.03@free.fr
    • Principal Investigator: Jean-Christophe ORBAN, MD
    • Sub-Investigator: Carole ICHAI, MD, PhD
    • Sub-Investigator: Hervé QUINTARD, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Department of Clinical Research and Innovation
• Collaborators: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Jean-Christophe ORBAN, MD, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Anticipated): March 1, 2013
• Study Completion (Anticipated): March 1, 2013

Study Registration Dates

• First Submitted: February 22, 2010
• First Submitted That Met QC Criteria: February 22, 2010
• First Posted (Estimate): February 23, 2010

Study Record Updates

• Last Update Posted (Estimate): March 26, 2012
• Last Update Submitted That Met QC Criteria: March 23, 2012
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: 2009-A01187-50