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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00886184
First Posted: April 22, 2009
Last Update Posted: January 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Grenoble
  Purpose
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.

Condition Intervention
Cardiac Arrest Procedure: Hypothermia. Procedure: No early hypothermia

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intra-arrest Therapeutic Hypothermia in Prehospital Cardiac Arrest. Impact on Biomarker of Brain Damage.

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • 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 Measures:
  • Prove the efficacy of early therapeutic induced hypothermia in the reduction of pro-inflammatory cytokines secretion. [ Time Frame: 72 hours ]
  • Determine the number of Return of Spontaneous Circulation (ROSC), patients survival. [ Time Frame: 72 hours ]
  • Determine neurological status 48 hours after cardiac arrest (GCS) [ Time Frame: 48 hours ]
  • Determine impact following initial cardiac rhythm. [ Time Frame: 72 hours ]
  • Determine the cooling rate of early therapeutic induced hypothermia. [ Time Frame: 72 hours ]
  • Determine neurological status when leaving hospital (or 28 days if not applicable) (CPC) [ Time Frame: 28 days ]

Enrollment: 244
Study Start Date: February 2009
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Induction of pre hospital early hypothermia in patients having a cardiac .
Procedure: Hypothermia.
Induction of pre hospital therapeutic hypothermia.
Active Comparator: 2
Induction of hypothermia only at hospital arrival.
Procedure: No early hypothermia
Induction of therapeutic hypothermia only once arrived at hospital.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00886184


Locations
France
University Hospital Grenoble
Grenoble, France, 38045
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Guillaume DEBATY, MD Emergency department - Mobile Intensive Care Unit
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00886184     History of Changes
Other Study ID Numbers: 0821
2008-A01488-47 ( Registry Identifier: ID RCB )
First Submitted: April 20, 2009
First Posted: April 22, 2009
Last Update Posted: January 30, 2013
Last Verified: January 2013

Keywords provided by University Hospital, Grenoble:
Hypothermia
Cardiac arrest
Biomarkers
Pre hospital cardiac arrest

Additional relevant MeSH terms:
Heart Arrest
Hypothermia
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms