Therapeutic Hypothermia After Cardiac Arrest in Non Shockable Rhythm

Study Overview
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Brief Summary
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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.

Official Title
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Therapeutic Hypothermia After Cardiac Arrest in Non Shockable Rhythm at Rescue Arrival: The HYPERION Study

Conditions
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Cardiac Arrest

Intervention / Treatment
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* Procedure: Targeted controlled temperature between 32.5 and 33.5°C
* Procedure: Targeted controlled temperature between 36.5 and 37.5°C


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Targeted controlled temperature between 32.5 and 33.5°C<br>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. | Procedure: Targeted controlled temperature between 32.5 and 33.5°C<br>* Therapeutic hypothermia ie targeted controlled temperature between 32.5° and 33.5°C will be induced in the active group. Usual method of controlled temperature will be use in ICU: internal active method or external active method.<br>* Other names: Induce hypothermia;Procedure: Targeted controlled temperature between 36.5 and 37.5°C<br>* Temperature was maintain between 36.5° and 37.5°C in the control group. In case of temperature superior to 37.5°C or inferior to 36.5°C, a pharmaceutical treatment and/or active cooling or warming was introduce to maintain temperature between the range of 36.5 - 37.5°C.<br>* Other names: Normothermia;|
| Placebo Comparator: Targeted controlled temperature between 36.5 and 37.5°C<br>Patients will be placed in targeted temperature control between 36.5 and 37.5 ° C for 48 hours. | Procedure: Targeted controlled temperature between 36.5 and 37.5°C<br>* Temperature was maintain between 36.5° and 37.5°C in the control group. In case of temperature superior to 37.5°C or inferior to 36.5°C, a pharmaceutical treatment and/or active cooling or warming was introduce to maintain temperature between the range of 36.5 - 37.5°C.<br>* Other names: Normothermia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological outcome assessed with Cerebral Performance Category scale |  | Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensive Care Unit Mortality | Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 7 days. | Discharge from Intensive Care Unit, an expected average of 7 days | 
| Hospital Mortality | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks | Discharge from hospital, an expected average of 2 weeks | 
| Mortality at day 90 |  | Day 90 | 
| Quality of life Score | Quality of life at day 90 will be assessed by 36-Items Short Form for Health Survey telephonic interview | Day 90 | 
| Life autonomy | Life autonomy will be assessed by Index Activity of Daily Living, modified Barthel index, and by two normative question about life autonomy | Day 90 | 
| Neurocognitive evaluation | Neurocognitive status will be assessed by telephonic validated version of Mini Mental State Examination | Day 90 | 
| Post traumatic stress disorders symptoms | Post traumatic stress disorders symptoms will be assessed by Impact Event Scale Revised | Day 90 | 
| Intensive Care Unit length of stay | Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 7 days | Discharge from Intensive Care Unit, an expected average of 7 days | 
| Hospital length of stay | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks. | Discharge from hospital, an expected average of 2 weeks | 
| Mechanical ventilation duration | Participants will be followed for the duration of mechanical ventilation, an expected average of 4 days | Time from extubation, an expected average of 4 days | 
| Severe hemorrhage | Severe hemorrhage is define by transfusion of 1 or more blood product requirement and/or intracranial hemorrhage. Participants will be followed for the duration of Intensive care unit stay, an expected average of 7 days. | Intensive care unit length of stay, an expected average of 7 days | 
| Nosocomial Bloodstream infection | Participants will be followed for the duration of Intensive care unit stay, an expected average of 7 days. | Intensive care unit length of stay, an expected average of 7 days | 
| Early onset pneumonia |  | 2 days | 
| Ventilated Associated Pneumonia | Participants will be followed for the duration of mechanical ventilation, an expected average of 4 days | Duration of mechanical ventilation, an expected average of 4 days | 
| Central Veinous Catheter infection | Participants will be followed for the duration of Intensive care unit stay, an expected average of 7 days. | Intensive care unit length of stay, an expected average of 7 days | 
| Total dose of inotropic drugs | Total dose of different inotropic drugs (Epinephrine, Norepinephrine, Dobutamine) will be compare between 2 groups during targetted controlled temperature management period. | 48 hours | 
| Extra renal support requirement | Participants will be followed for the duration of Intensive care unit stay, an expected average of 7 days | Intensive care unit length of stay, an expected 7 days | 
| Acute pulmonary oedema by left ventricular failure | Participants will be followed for the duration of Intensive care unit stay, an expected average of 7 days. | Intensive care length of stay, an expected 7 days | 
| Seizure | Participants will be followed for the duration of Intensive care unit stay, an expected average of 7 days | Intensive care length of stay, an expected 7 days | 
| Severe arrythmia | Severe arrythmia will be define by salvo of ventricular extrasystole, ventricular fibrillation, ventricular tachycardia, need an external shock, need anti-arrhythmic treatment. Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 7 days. | Intensive care unit length of stay, an expected 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Therapeutic hypothermia, Targeted controlled temperature, Cardiac arrest, Non shockable rhythm, successful resuscitation