Therapeutic Hypothermia After Cardiac Arrest in Non Shockable Rhythm (HYPERION)

Centre Hospitalier Departemental Vendee

Status: Completed

Conditions: Cardiac Arrest

Treatments: Procedure: Targeted controlled temperature between 32.5 and 33.5°C; Procedure: Targeted controlled temperature between 36.5 and 37.5°C

Study type: Interventional

Funder types: Other

Identifiers

NCT01994772

RCB 2012-A00405-38

Details and patient eligibility

About

Cardiac arrest is at present a major cause of mortality as well as a cause of disability for the surviving victims.In Europe, every year counts as 300,000 cardiac arrests responsible for 250,000 deaths. Thus, less than 20 % of patients discharged home with impaired quality of life associated with symptoms of tiredness, stress, anxiety. The prognosis is related to the initial cardiac rhythm present during the initiation of resuscitation. Recent progress in the improvement of mortality and neurological outcome has been achieved over the last decade thanks to the systematic implementation of a period of targeted temperature control between 32 and 34 ° C in patients who benefited from the realization of at least one electrical external shock.

There are theoretical and clinical arguments to think that achieving the same way a period of targeted temperature control between 32 and 34 ° C in patients treated for cardiac arrest with a non- shockable rhythm on arrival can also benefit from this procedure. However other arguments are against this hypothesis including an increase in the risk of infection , worsening of the patient's hemodynamic status with no benefit to him. To answer this question, we conduce a randomized multicenter study testing the potential improvement of neurological outcome through this procedure targeted temperature control between 32.5 and 33.5 ° C in these patients.

Enrollment: 584 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cardiac arrest in non shockable rhythm
• Glasgow score ≤ 8

Exclusion criteria

• No flow > 10 min
• Low flow > 60 min
• Major hemodynamic instability
• Delay between cardiac arrest and inclusion > 300 min
• Cirrhosis Child C
• Age < 18 years
• Pregnant women
• Patient with no liberty
• Lack of informed consent
• Prior inclusion in a research protocol involving cardiac arrest with draw, and whose primary endpoint focuses on the evaluation of a neurological score Day 90

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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584 participants in 2 patient groups, including a placebo group

Targeted controlled temperature between 32.5 and 33.5°C

Active Comparator group

Description:

Patients will be placed in targeted temperature control between 32.5 and 33.5 ° C for 24 hours and then slowly rewarmed for targeted temperature control between 36.5 and 37.5 ° C for 24 hours.

Treatment:

Procedure: Targeted controlled temperature between 36.5 and 37.5°C

Procedure: Targeted controlled temperature between 32.5 and 33.5°C

Targeted controlled temperature between 36.5 and 37.5°C

Placebo Comparator group

Description:

Patients will be placed in targeted temperature control between 36.5 and 37.5 ° C for 48 hours.

Treatment:

Procedure: Targeted controlled temperature between 36.5 and 37.5°C