NCT00886184

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2009

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

January 30, 2013

Status Verified

January 1, 2013

Enrollment Period

3.5 years

First QC Date

April 20, 2009

Last Update Submit

January 29, 2013

Conditions

Cardiac Arrest

Keywords

HypothermiaCardiac arrestBiomarkersPre hospital cardiac arrest

Outcome Measures

Primary Outcomes (1)

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

    72 hours

Secondary Outcomes (6)

  • Prove the efficacy of early therapeutic induced hypothermia in the reduction of pro-inflammatory cytokines secretion.

    72 hours

  • Determine the number of Return of Spontaneous Circulation (ROSC), patients survival.

    72 hours

  • Determine neurological status 48 hours after cardiac arrest (GCS)

    48 hours

  • Determine impact following initial cardiac rhythm.

    72 hours

  • Determine the cooling rate of early therapeutic induced hypothermia.

    72 hours

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

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

Procedure: Hypothermia.

2

ACTIVE COMPARATOR

Induction of hypothermia only at hospital arrival.

Procedure: No early hypothermia

Interventions

Hypothermia.PROCEDURE

Induction of pre hospital therapeutic hypothermia.

1
No early hypothermiaPROCEDURE

Induction of therapeutic hypothermia only once arrived at hospital.

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pre hospital cardiac arrest

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Grenoble

Grenoble, 38045, France

Location

Related Publications (1)

  • 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.

    PMID: 24188226DERIVED

MeSH Terms

Conditions

Heart ArrestHypothermia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Guillaume DEBATY, MD

    Emergency department - Mobile Intensive Care Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2009

First Posted

April 22, 2009

Study Start

February 1, 2009

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

January 30, 2013

Record last verified: 2013-01

Locations

FR(1)