Back to resultsEvaluation of the Prognostic Value of the Suppression Ratio Evaluated by BIS Among Patients Admitted to the ICU for Cardiac Arrest (SACRE)
Primary Purpose
Cardiac Arrest
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Aspect BIS XP (A-2000) Bispectral Index Patient Monitor
Sponsored by
About this trial
This is an interventional diagnostic trial for Cardiac Arrest
Eligibility Criteria
Inclusion Criteria:
- Adult
- Cardiac arrest admitted to the ICU
Exclusion Criteria:
- Pregnancy
Sites / Locations
- CHRU Besançon
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single arm
Arm Description
arm wherein all patients Suppression Ratio evaluated by BIS will be collected
Outcomes
Primary Outcome Measures
Cerebral Performance Category score
Secondary Outcome Measures
Full Information
NCT ID
NCT02869997
First Posted
August 12, 2016
Last Updated
August 12, 2016
Sponsor
Centre Hospitalier Universitaire de Besancon
1. Study Identification
Unique Protocol Identification Number
NCT02869997
Brief Title
Evaluation of the Prognostic Value of the Suppression Ratio Evaluated by BIS Among Patients Admitted to the ICU for Cardiac Arrest
Acronym
SACRE
Official Title
Evaluation of the Prognostic Value of the Suppression Ratio Evaluated by BIS Among Patients Admitted to the ICU for Cardiac Arrest
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
May 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm
Arm Type
Experimental
Arm Description
arm wherein all patients Suppression Ratio evaluated by BIS will be collected
Intervention Type
Device
Intervention Name(s)
Aspect BIS XP (A-2000) Bispectral Index Patient Monitor
Primary Outcome Measure Information:
Title
Cerebral Performance Category score
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult
Cardiac arrest admitted to the ICU
Exclusion Criteria:
- Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Belon, MD
Organizational Affiliation
CHRU Besançon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Prognostic Value of the Suppression Ratio Evaluated by BIS Among Patients Admitted to the ICU for Cardiac Arrest
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