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Intra-arrest Therapeutic Hypothermia in Prehospital Cardiac Arrest (HITUPPAC-BIO)

Primary Purpose

Cardiac Arrest

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hypothermia.
No early hypothermia
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring Hypothermia, Cardiac arrest, Biomarkers, Pre hospital cardiac arrest

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • pre hospital cardiac arrest

Exclusion Criteria:

  • under 18 years old
  • pregnancy or breastfeeding women
  • patient under guardianship.
  • not beneficing a social health care system.
  • cardiac arrest of traumatic origin
  • patients with an initial body temperature under 34° C
  • cardiac arrests for which resuscitation maneuvers seem unjustified (DNR criteria)

Sites / Locations

  • University Hospital Grenoble

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Induction of pre hospital early hypothermia in patients having a cardiac .

Induction of hypothermia only at hospital arrival.

Outcomes

Primary Outcome Measures

Prove efficacy of early induced hypothermia during ischemia in pre hospital cardiac arrest by a reduction of brain damage biomarkers.

Secondary Outcome Measures

Prove the efficacy of early therapeutic induced hypothermia in the reduction of pro-inflammatory cytokines secretion.
Determine the number of Return of Spontaneous Circulation (ROSC), patients survival.
Determine neurological status 48 hours after cardiac arrest (GCS)
Determine impact following initial cardiac rhythm.
Determine the cooling rate of early therapeutic induced hypothermia.
Determine neurological status when leaving hospital (or 28 days if not applicable) (CPC)

Full Information

First Posted
April 20, 2009
Last Updated
January 29, 2013
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT00886184
Brief Title
Intra-arrest Therapeutic Hypothermia in Prehospital Cardiac Arrest
Acronym
HITUPPAC-BIO
Official Title
Intra-arrest Therapeutic Hypothermia in Prehospital Cardiac Arrest. Impact on Biomarker of Brain Damage.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim is to precise the place of therapeutic hypothermia induced before Return of Spontaneous Circulation (ROSC) in pre hospital cardiac arrest. If we find a benefit in terms of biomarkers in inducing in early hypothermia compared to hypothermia induced only after arrival at the hospital, there will be arguments to develop a higher scale study, allowing to prove benefits in terms of survival and neurological status.
Detailed Description
Principal aim : prove the efficiency of early therapeutic hypothermia induced during ischemia in pre hospital cardiac arrest by a reduction of brain damage biomarkers. Secondary aim: prove the efficiency of early therapeutic induced hypothermia in the reduction of pro-inflammatory cytokines secretion. Determine the number of ROSC, patients survival, neurological status 48 hours after cardiac arrest (GCS) and when leaving the hospital, impact following initial cardiac rhythm and the cooling rate of early therapeutic induced hypothermia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
Hypothermia, Cardiac arrest, Biomarkers, Pre hospital cardiac arrest

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
244 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Induction of pre hospital early hypothermia in patients having a cardiac .
Arm Title
2
Arm Type
Active Comparator
Arm Description
Induction of hypothermia only at hospital arrival.
Intervention Type
Procedure
Intervention Name(s)
Hypothermia.
Intervention Description
Induction of pre hospital therapeutic hypothermia.
Intervention Type
Procedure
Intervention Name(s)
No early hypothermia
Intervention Description
Induction of therapeutic hypothermia only once arrived at hospital.
Primary Outcome Measure Information:
Title
Prove efficacy of early induced hypothermia during ischemia in pre hospital cardiac arrest by a reduction of brain damage biomarkers.
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Prove the efficacy of early therapeutic induced hypothermia in the reduction of pro-inflammatory cytokines secretion.
Time Frame
72 hours
Title
Determine the number of Return of Spontaneous Circulation (ROSC), patients survival.
Time Frame
72 hours
Title
Determine neurological status 48 hours after cardiac arrest (GCS)
Time Frame
48 hours
Title
Determine impact following initial cardiac rhythm.
Time Frame
72 hours
Title
Determine the cooling rate of early therapeutic induced hypothermia.
Time Frame
72 hours
Title
Determine neurological status when leaving hospital (or 28 days if not applicable) (CPC)
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: pre hospital cardiac arrest Exclusion Criteria: under 18 years old pregnancy or breastfeeding women patient under guardianship. not beneficing a social health care system. cardiac arrest of traumatic origin patients with an initial body temperature under 34° C cardiac arrests for which resuscitation maneuvers seem unjustified (DNR criteria)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume DEBATY, MD
Organizational Affiliation
Emergency department - Mobile Intensive Care Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Grenoble
City
Grenoble
ZIP/Postal Code
38045
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
24188226
Citation
Ferreira Da Silva IR, Frontera JA. Targeted temperature management in survivors of cardiac arrest. Cardiol Clin. 2013 Nov;31(4):637-55, ix. doi: 10.1016/j.ccl.2013.07.010.
Results Reference
derived

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Intra-arrest Therapeutic Hypothermia in Prehospital Cardiac Arrest

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