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NCT02869997 Clinical Trial

Evaluation of the Prognostic Value of the Suppression Ratio Evaluated by BIS Among Patients Admitted to the ICU for Cardiac Arrest

Cardiac Arrest Clinical Trial

— SACRE  

Official title:
Evaluation of the Prognostic Value of the Suppression Ratio Evaluated by BIS Among Patients Admitted to the ICU for Cardiac Arrest

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02869997
Other study ID # P/2012/128
Secondary ID
Status Active, not recruiting
Phase N/A
First received August 12, 2016
Last updated August 12, 2016
Start date August 2012
Est. completion date May 2017

Study information
Verified date August 2016
Source Centre Hospitalier Universitaire de Besancon
Contact n/a
Is FDA regulated No
Health authority France: Committee for the Protection of PersonnesFrance: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial Summary

The aim of this study is to evaluate the prognostic value of the suppression ratio monitored by Bispectral Index for prediction of neurologic outcome after cardiac arrest. All patient admitted to our intensive care unit after a cardiac arrest are included. The results of the suppression ratio will be collected in the 6 first hours of admission. We will evaluate the link between suppression ratio and cerebral performance category score collected at three months.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 102
Est. completion date May 2017
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult

- Cardiac arrest admitted to the ICU

Exclusion Criteria:

- Pregnancy

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Device:
• Aspect BIS XP (A-2000) Bispectral Index Patient Monitor

Locations
Country Name City State
France CHRU Besançon Besançon

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cerebral Performance Category score 3 months No
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