Therapeutic Hypothermia After Cardiac Arrest in Non Shockable Rhythm
NCT ID: NCT01994772
Last Updated: 2019-01-16
Study Results
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Basic Information
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COMPLETED
NA
584 participants
INTERVENTIONAL
2014-01-26
2018-04-09
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Targeted controlled temperature between 32.5 and 33.5°C
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.
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.
Targeted controlled temperature between 36.5 and 37.5°C
Patients will be placed in targeted temperature control between 36.5 and 37.5 ° C for 48 hours.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Glasgow score ≤ 8
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Tours
OTHER
Centre Hospitalier Departemental Vendee
OTHER
Responsible Party
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Principal Investigators
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Jean Baptiste Lascarrou, MD
Role: STUDY_CHAIR
Nantes University Hospital
Locations
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Medical Intensive Care Unit
Angers, , France
Medical Surgical Intensive Care Unit
Angoulême, , 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
Orléans, , 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-Nazaire, , France
Medical Surgical Intensive Care Unit
St-Malo, , France
Medical Intensive Care Unit
Strasbourg, , France
Medical Intensive Care Unit
Tours, , France
Medical Surgical Intensive Care Unit
Versailles, , France
CHU Pointe à Pitre
Pointe-à-Pitre, , Guadeloupe
Countries
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References
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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.
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.
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.
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.
Related Links
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Related Info
Other Identifiers
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RCB 2012-A00405-38
Identifier Type: -
Identifier Source: org_study_id
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