Therapeutic Hypothermia After Cardiac Arrest in Non Shockable Rhythm

NCT01994772 — Not applicable, Completed, 584 participants, Centre Hospitalier Departemental Vendee

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

RegistryNCT01994772, acronym HYPERION
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, single group, masking: single, treatment
Enrollment584 (Actual)
SponsorCentre Hospitalier Departemental Vendee (Other); collaborators: University Hospital, Tours
ConditionsCardiac Arrest
InterventionsTargeted controlled temperature between 32.5 and 33.5°C, Targeted controlled temperature between 36.5 and 37.5°C (Procedure)
Datesstart 2014-01-26, primary completion 2018-04-09, completion 2018-04-09, first posted 2013-11-26, last updated 2019-01-16
Locations26 sites in France, Guadeloupe

Related Papers Related Patents Related Grants Related Experts
All trials for Cardiac Arrest All trials of Targeted controlled temperature between 32.5 and 33.5°C All trials of Targeted controlled temperature between 36.5 and 37.5°C

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Targeted controlled temperature between 32.5 and 33.5°CActive comparatorProcedure: Targeted controlled temperature between 32.5 and 33.5°C; Procedure: Targeted controlled temperature between 36.5 and 37.5°CPatients 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.
Targeted controlled temperature between 36.5 and 37.5°CPlacebo comparatorProcedure: Targeted controlled temperature between 36.5 and 37.5°CPatients will be placed in targeted temperature control between 36.5 and 37.5 ° C for 48 hours.
  • Targeted controlled temperature between 32.5 and 33.5°C (Procedure), also known as Therapeutic hypothermia, Induce hypothermia: 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 (Procedure), also known as Normothermia: 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.

+Outcome measures

Primary outcomes

  • Neurological outcome assessed with Cerebral Performance Category scale [Day 90]

Secondary outcomes

  • Intensive Care Unit Mortality [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.
  • Hospital Mortality [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
  • Mortality at day 90 [Day 90]
  • Quality of life Score [Day 90]: Quality of life at day 90 will be assessed by 36-Items Short Form for Health Survey telephonic interview
  • Life autonomy [Day 90]: Life autonomy will be assessed by Index Activity of Daily Living, modified Barthel index, and by two normative question about life autonomy
  • Neurocognitive evaluation [Day 90]: Neurocognitive status will be assessed by telephonic validated version of Mini Mental State Examination
  • Post traumatic stress disorders symptoms [Day 90]: Post traumatic stress disorders symptoms will be assessed by Impact Event Scale Revised
  • Intensive Care Unit length of stay [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
  • Hospital length of stay [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.
  • Mechanical ventilation duration [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
  • Severe hemorrhage [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.
  • Nosocomial Bloodstream infection [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.
  • Early onset pneumonia [2 days]
  • Ventilated Associated Pneumonia [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
  • Central Veinous Catheter infection [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.
  • Total dose of inotropic drugs [48 hours]: Total dose of different inotropic drugs (Epinephrine, Norepinephrine, Dobutamine) will be compare between 2 groups during targetted controlled temperature management period.
  • Extra renal support requirement [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
  • Acute pulmonary oedema by left ventricular failure [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.
  • Seizure [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
  • Severe arrythmia [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.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (26)

FacilityCityCountryStatus
Medical Intensive Care UnitAngersFrance
Medical Surgical Intensive Care UnitAngoulêmeFrance
Medical Intensive Care UnitAnnecyFrance
Medical Surgical Intensive Care UnitArgenteuilFrance
Medical Intensive Care UnitClermont-FerrandFrance
Medical Intensive Care UnitDijonFrance
Medical Surgical Intensive Care UnitLa Roche-sur-YonFrance
Medical Surgical Intensive Care UnitLe MansFrance
Medical Surgical Intensive Care UnitLensFrance
Medical Intensive Care UnitLilleFrance
Medical Surgical Intensive Care UnitLimogesFrance
Medical Surgical Intensive Care UnitLorientFrance
Medical Surgical Intensive Care UnitMontaubanFrance
Medical Intensive Care UnitNantesFrance
Medical Intensive Care UnitOrléansFrance
Cochin University Hospital CenterParisFrance
Medical Intensive Care UnitPoitiersFrance
Medical Surgical Intensive Care UnitRoanneFrance
Medical Surgical Intensive Care UnitRodezFrance
Medical Surgical Intensive Care UnitSaint-BrieucFrance
Medical Surgical Intensive Care UnitSaint-NazaireFrance
Medical Surgical Intensive Care UnitSt-MaloFrance
Medical Intensive Care UnitStrasbourgFrance
Medical Intensive Care UnitToursFrance
Medical Surgical Intensive Care UnitVersaillesFrance
CHU Pointe à PitrePointe-à-PitreGuadeloupe

+Publications

  • Results publication: Lascarrou JB, Ermel C, Cariou A, Laitio T, Kirkegaard H, Soreide E, Grejs AM, Reinikainen M, Colin G, Taccone FS, Le Gouge A, Skrifvars MB. Dysnatremia at ICU admission and functional outcome of cardiac arrest: insights from four randomised controlled trials. Crit Care. 2023 Dec 1;27(1):472. doi: 10.1186/s13054-023-04715-z. PMID 38041177
  • Results publication: 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. PMID 36251223
  • Results publication: 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. PMID 31577396
  • Results publication: 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. PMID 25882712

+Investigators