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

Cardiac Arrest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01073098
• Other study ID #: 2009-A01187-50
• Status: Recruiting
• Phase: N/A
• First received: February 22, 2010
• Last updated: March 23, 2012
• Start date: March 2010
• Est. completion date: March 2013

Study information

• Verified date: December 2011
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Jean-Christophe ORBAN, MD
• Phone: +33 4 92 03 33 00
• Email: orban.j[@]chu-nice.fr
• Is FDA regulated: No
• Health authority: France: French Data Protection AuthorityFrance: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 51
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

Other:
• Vascular occlusion test
Reperfusion slope after vascular occlusion test

Locations

Country	Name	City	State
France	CHU de Nice -Hôpital l'Archet	Nice
France	CHU de Nice Hôpital Saint Roch	Nice

Sponsors (2)

Lead Sponsor	Collaborator
Department of Clinical Research and Innovation	Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No