NCT Number: NCT01994772
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Medical Intensive Care Unit, Angers, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Therapeutic hypothermia, Induce hypothermia
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.
Other names: Normothermia
Time frame: Day 90
Time frame: Discharge from Intensive Care Unit, an expected average of 7 days
Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 7 days.
Time frame: Discharge from hospital, an expected average of 2 weeks
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Time frame: Day 90
Time frame: Day 90
Quality of life at day 90 will be assessed by 36-Items Short Form for Health Survey telephonic interview
Time frame: Day 90
Life autonomy will be assessed by Index Activity of Daily Living, modified Barthel index, and by two normative question about life autonomy
Time frame: Day 90
Neurocognitive status will be assessed by telephonic validated version of Mini Mental State Examination
Time frame: Day 90
Post traumatic stress disorders symptoms will be assessed by Impact Event Scale Revised
Time frame: Discharge from Intensive Care Unit, an expected average of 7 days
Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 7 days
Time frame: Discharge from hospital, an expected average of 2 weeks
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Time frame: Time from extubation, an expected average of 4 days
Participants will be followed for the duration of mechanical ventilation, an expected average of 4 days
Time frame: Intensive care unit length of stay, an expected average of 7 days
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.
Time frame: Intensive care unit length of stay, an expected average of 7 days
Participants will be followed for the duration of Intensive care unit stay, an expected average of 7 days.
Time frame: 2 days
Time frame: Duration of mechanical ventilation, an expected average of 4 days
Participants will be followed for the duration of mechanical ventilation, an expected average of 4 days
Time frame: Intensive care unit length of stay, an expected average of 7 days
Participants will be followed for the duration of Intensive care unit stay, an expected average of 7 days.
Time frame: 48 hours
Total dose of different inotropic drugs (Epinephrine, Norepinephrine, Dobutamine) will be compare between 2 groups during targetted controlled temperature management period.
Time frame: Intensive care unit length of stay, an expected 7 days
Participants will be followed for the duration of Intensive care unit stay, an expected average of 7 days
Time frame: Intensive care length of stay, an expected 7 days
Participants will be followed for the duration of Intensive care unit stay, an expected average of 7 days.
Time frame: Intensive care length of stay, an expected 7 days
Participants will be followed for the duration of Intensive care unit stay, an expected average of 7 days
Time frame: Intensive care unit length of stay, an expected 7 days
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.
Centre Hospitalier Departemental Vendee
Other
Therapeutic Hypothermia After Cardiac Arrest in Non Shockable Rhythm at Rescue Arrival: The HYPERION Study
Acronym: HYPERION
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.
Published trials that share one or more normalized conditions with this study.
NCT06836908
Cardiac Arrest, Cardiovascular Diseases
Vienna, Austria
View Trial DetailsNCT05756621
Cardiac Arrest, Cardiovascular Diseases
Brescia, BS, Italy
View Trial DetailsNCT02527031
Cardiac Arrest, Cardiovascular Diseases
Paris, France
View Trial DetailsNCT03817892
Cardiac Arrest, Cardiopulmonary Resuscitation
Caen, Normandy, France
View Trial Details