Therapeutic Hypothermia After Cardiac Arrest in Non Shockable Rhythm

Cardiac Arrest Clinical Trial

— HYPERION  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01994772
• Other study ID #: RCB 2012-A00405-38
• Status: Completed
• Phase: N/A
• Start date: January 26, 2014
• Est. completion date: April 9, 2018

Study information

• Verified date: January 2019
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 584
• Est. completion date: April 9, 2018
• Est. primary completion date: April 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Hypothermia

Intervention

Procedure:
• Targeted controlled temperature between 32.5 and 33.5°C
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.
• Targeted controlled temperature between 36.5 and 37.5°C
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.

Locations

Country	Name	City	State
France	Medical Intensive Care Unit	Angers
France	Medical Surgical Intensive Care Unit	Angouleme
France	Medical Intensive Care Unit	Annecy
France	Medical Surgical Intensive Care Unit	Argenteuil
France	Medical Intensive Care Unit	Clermont-Ferrand
France	Medical Intensive Care Unit	Dijon
France	Medical Surgical Intensive Care Unit	La Roche Sur Yon
France	Medical Surgical Intensive Care Unit	Le Mans
France	Medical Surgical Intensive Care Unit	Lens
France	Medical Intensive Care Unit	Lille
France	Medical Surgical Intensive Care Unit	Limoges
France	Medical Surgical Intensive Care Unit	Lorient
France	Medical Surgical Intensive Care Unit	Montauban
France	Medical Intensive Care Unit	Nantes
France	Medical Intensive Care Unit	Orleans
France	Cochin University Hospital Center	Paris
France	Medical Intensive Care Unit	Poitiers
France	Medical Surgical Intensive Care Unit	Roanne
France	Medical Surgical Intensive Care Unit	Rodez
France	Medical Surgical Intensive Care Unit	Saint Brieuc
France	Medical Surgical Intensive Care Unit	Saint Malo
France	Medical Surgical Intensive Care Unit	Saint Nazaire
France	Medical Intensive Care Unit	Strasbourg
France	Medical Intensive Care Unit	Tours
France	Medical Surgical Intensive Care Unit	Versailles
Guadeloupe	CHU Pointe à Pitre	Pointe-à-Pitre

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee	University Hospital, Tours

Countries where clinical trial is conducted

France,  Guadeloupe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurological outcome assessed with Cerebral Performance Category scale		Day 90
Secondary	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
Secondary	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
Secondary	Mortality at day 90		Day 90
Secondary	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
Secondary	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
Secondary	Neurocognitive evaluation	Neurocognitive status will be assessed by telephonic validated version of Mini Mental State Examination	Day 90
Secondary	Post traumatic stress disorders symptoms	Post traumatic stress disorders symptoms will be assessed by Impact Event Scale Revised	Day 90
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Early onset pneumonia		2 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

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