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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00886184
First received: April 20, 2009
Last updated: January 29, 2013
Last verified: January 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prove the efficacy of early therapeutic induced hypothermia in the reduction of pro-inflammatory cytokines secretion. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Determine the number of Return of Spontaneous Circulation (ROSC), patients survival. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Determine neurological status 48 hours after cardiac arrest (GCS) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Determine impact following initial cardiac rhythm. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Determine the cooling rate of early therapeutic induced hypothermia. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Determine neurological status when leaving hospital (or 28 days if not applicable) (CPC) [ Time Frame: 28 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University Hospital, Grenoble

Additional 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
Study First Received: April 20, 2009
Last Updated: January 29, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on July 29, 2014