Skip to main content
OpenTrials
Completed

NCT Number: NCT00886184

Intra-arrest Therapeutic Hypothermia in Prehospital Cardiac Arrest

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiac Arrest Body Temperature Changes Cardiovascular Diseases Heart Arrest Heart Diseases Hypothermia Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Grenoble

Grenoble, 38045, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Hypothermia.

Procedure

Induction of pre hospital therapeutic hypothermia.

No early hypothermia

Procedure

Induction of therapeutic hypothermia only once arrived at hospital.

Primary outcomes

  1. 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 outcomes

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

    Time frame: 72 hours

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

    Time frame: 72 hours

  3. Determine neurological status 48 hours after cardiac arrest (GCS)

    Time frame: 48 hours

  4. Determine impact following initial cardiac rhythm.

    Time frame: 72 hours

  5. Determine the cooling rate of early therapeutic induced hypothermia.

    Time frame: 72 hours

  6. Determine neurological status when leaving hospital (or 28 days if not applicable) (CPC)

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Intra-arrest Therapeutic Hypothermia in Prehospital Cardiac Arrest. Impact on Biomarker of Brain Damage.

Acronym: HITUPPAC-BIO

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Apr 22, 2009
Registry last updated
Jan 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.