Intra-Arrest Therapeutic Hypothermia in Prehospital Cardiac Arrest - Full Text View

Sponsor:	University Hospital, Grenoble
Information provided by:	University Hospital, Grenoble
ClinicalTrials.gov Identifier:	NCT00886184

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:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Intra-Arrest Therapeutic Hypothermia in Prehospital Cardiac Arrest. Impact on Biomarker of Brain Damage.

Resource links provided by NLM:

MedlinePlus related topics: Hypothermia Traumatic Brain Injury

U.S. FDA Resources

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 ]

Estimated Enrollment:	250
Study Start Date:	February 2009
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Induction of pre hospital early hypothermia in patients having a cardiac .	Procedure: Hypothermia. Induction of pre hospital therapeutic hypothermia.
2: Active Comparator 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00886184

Contacts

Contact: Guillaume DEBATY, MD	04 76 63 42 02	GDebaty@chu-grenoble.fr
Contact: Jean François TIMSIT, MD, PhD	04 76 76 87 79	JFTimsit@chu-grenoble.fr

Locations

France
University Hospital Grenoble	Recruiting
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

Responsible Party:	SAMU 38 ( Guillaume DEBATY, MD )
Study ID Numbers:	0821, 2008-A01488-47
Study First Received:	April 20, 2009
Last Updated:	April 24, 2009
ClinicalTrials.gov Identifier:	NCT00886184 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Grenoble:

Hypothermia
Cardiac arrest
Biomarkers
Pre hospital cardiac arrest

Additional relevant MeSH terms:

Signs and Symptoms
Hypothermia
Heart Diseases

Cardiovascular Diseases
Heart Arrest
Body Temperature Changes

ClinicalTrials.gov processed this record on February 08, 2010