Clinical trial NCT01994772: Therapeutic Hypothermia After Cardiac Arrest in Non Shockable Rhythm
Official title: Therapeutic Hypothermia After Cardiac Arrest in Non Shockable Rhythm at Rescue Arrival: The HYPERION Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Keywords: Therapeutic hypothermia
Targeted controlled temperature
Cardiac arrest
Non shockable rhythm
successful resuscitation
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
Collaborators: name: University Hospital, Tours
First posted: 2013-11-26
Enrollment: 584
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Neurological outcome assessed with Cerebral Performance Category scale
timeFrame: Day 90
Secondary outcomes:
measure: Intensive Care Unit Mortality
timeFrame: Discharge from Intensive Care Unit, an expected average of 7 days
measure: Hospital Mortality
timeFrame: Discharge from hospital, an expected average of 2 weeks
measure: Mortality at day 90
timeFrame: Day 90
measure: Quality of life Score
timeFrame: Day 90
measure: Life autonomy
timeFrame: Day 90
measure: Neurocognitive evaluation
timeFrame: Day 90
measure: Post traumatic stress disorders symptoms
timeFrame: Day 90
measure: Intensive Care Unit length of stay
timeFrame: Discharge from Intensive Care Unit, an expected average of 7 days
measure: Hospital length of stay
timeFrame: Discharge from hospital, an expected average of 2 weeks
measure: Mechanical ventilation duration
timeFrame: Time from extubation, an expected average of 4 days
measure: Severe hemorrhage
timeFrame: Intensive care unit length of stay, an expected average of 7 days
measure: Nosocomial Bloodstream infection
timeFrame: Intensive care unit length of stay, an expected average of 7 days
measure: Early onset pneumonia
timeFrame: 2 days
measure: Ventilated Associated Pneumonia
timeFrame: Duration of mechanical ventilation, an expected average of 4 days
measure: Central Veinous Catheter infection
timeFrame: Intensive care unit length of stay, an expected average of 7 days
measure: Total dose of inotropic drugs
timeFrame: 48 hours
measure: Extra renal support requirement
timeFrame: Intensive care unit length of stay, an expected 7 days
measure: Acute pulmonary oedema by left ventricular failure
timeFrame: Intensive care length of stay, an expected 7 days
measure: Seizure
timeFrame: Intensive care length of stay, an expected 7 days
measure: Severe arrythmia
timeFrame: Intensive care unit length of stay, an expected 7 days
Other outcomes:
Locations:
city: Angers
country: France
facility: Medical Intensive Care Unit
city: Angouleme
country: France
facility: Medical Surgical Intensive Care Unit
city: Annecy
country: France
facility: Medical Intensive Care Unit
city: Argenteuil
country: France
facility: Medical Surgical Intensive Care Unit
city: Clermont-Ferrand
country: France
facility: Medical Intensive Care Unit
city: Dijon
country: France
facility: Medical Intensive Care Unit
city: La Roche Sur Yon
country: France
facility: Medical Surgical Intensive Care Unit
city: Le Mans
country: France
facility: Medical Surgical Intensive Care Unit
city: Lens
country: France
facility: Medical Surgical Intensive Care Unit
city: Lille
country: France
facility: Medical Intensive Care Unit
city: Limoges
country: France
facility: Medical Surgical Intensive Care Unit
city: Lorient
country: France
facility: Medical Surgical Intensive Care Unit
city: Montauban
country: France
facility: Medical Surgical Intensive Care Unit
city: Nantes
country: France
facility: Medical Intensive Care Unit
city: Orleans
country: France
facility: Medical Intensive Care Unit
city: Paris
country: France
facility: Cochin University Hospital Center
city: Poitiers
country: France
facility: Medical Intensive Care Unit
city: Roanne
country: France
facility: Medical Surgical Intensive Care Unit
city: Rodez
country: France
facility: Medical Surgical Intensive Care Unit
city: Saint Brieuc
country: France
facility: Medical Surgical Intensive Care Unit
city: Saint Malo
country: France
facility: Medical Surgical Intensive Care Unit
city: Saint Nazaire
country: France
facility: Medical Surgical Intensive Care Unit
city: Strasbourg
country: France
facility: Medical Intensive Care Unit
city: Tours
country: France
facility: Medical Intensive Care Unit
city: Versailles
country: France
facility: Medical Surgical Intensive Care Unit
city: Pointe-à-Pitre
country: Guadeloupe
facility: CHU Pointe à Pitre
Study officials:
affiliation: Nantes University Hospital
name: Jean Baptiste Lascarrou, MD
role: STUDY_CHAIR
References:
citation: Ziriat I, Le Thuaut A, Colin G, Merdji H, Grillet G, Girardie P, Souweine B, Dequin PF, Boulain T, Frat JP, Asfar P, Francois B, Landais M, Plantefeve G, Quenot JP, Chakarian JC, Sirodot M, Legriel S, Massart N, Thevenin D, Desachy A, Delahaye A, Botoc V, Vimeux S, Martino F, Reignier J, Cariou A, Lascarrou JB. Outcomes of mild-to-moderate postresuscitation shock after non-shockable cardiac arrest and association with temperature management: a post hoc analysis of HYPERION trial data. Ann Intensive Care. 2022 Oct 17;12(1):96. doi: 10.1186/s13613-022-01071-z.
citation: Lascarrou JB, Merdji H, Le Gouge A, Colin G, Grillet G, Girardie P, Coupez E, Dequin PF, Cariou A, Boulain T, Brule N, Frat JP, Asfar P, Pichon N, Landais M, Plantefeve G, Quenot JP, Chakarian JC, Sirodot M, Legriel S, Letheulle J, Thevenin D, Desachy A, Delahaye A, Botoc V, Vimeux S, Martino F, Giraudeau B, Reignier J; CRICS-TRIGGERSEP Group. Targeted Temperature Management for Cardiac Arrest with Nonshockable Rhythm. N Engl J Med. 2019 Dec 12;381(24):2327-2337. doi: 10.1056/NEJMoa1906661. Epub 2019 Oct 2.
citation: Lascarrou JB, Meziani F, Le Gouge A, Boulain T, Bousser J, Belliard G, Asfar P, Frat JP, Dequin PF, Gouello JP, Delahaye A, Hssain AA, Chakarian JC, Pichon N, Desachy A, Bellec F, Thevenin D, Quenot JP, Sirodot M, Labadie F, Plantefeve G, Vivier D, Girardie P, Giraudeau B, Reignier J; Clinical Research in Intensive Care and Sepsis (CRICS) Group and HYPERION Study Group. Therapeutic hypothermia after nonshockable cardiac arrest: the HYPERION multicenter, randomized, controlled, assessor-blinded, superiority trial. Scand J Trauma Resusc Emerg Med. 2015 Mar 7;23:26. doi: 10.1186/s13049-015-0103-5.