Therapeutic Hypothermia After Cardiac Arrest in Non Shockable Rhythm

Conditions

Cardiac Arrest

Keywords

Therapeutic hypothermia, Targeted controlled temperature, Cardiac arrest, Non shockable rhythm, successful resuscitation

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.

Taccone FS, Dankiewicz J, Cariou A, Lilja G, Asfar P, Belohlavek J, Boulain T, Colin G, Cronberg T, Frat JP, Friberg H, Grejs AM, Grillet G, Girardie P, Haenggi M, Hovdenes J, Jakobsen JC, Levin H, Merdji H, Njimi H, Pelosi P, Rylander C, Saxena M, Thomas M, Young PJ, Wise MP, Nielsen N, Lascarrou JB.

2024-02-0112 citations

10.1001/jamaneurol.2023.4820

Dysnatremia at ICU admission and functional outcome of cardiac arrest: insights from four randomised controlled trials.

Lascarrou JB, Ermel C, Cariou A, Laitio T, Kirkegaard H, Søreide E, Grejs AM, Reinikainen M, Colin G, Taccone FS, Le Gouge A, Skrifvars MB.

2023-12-0110 citations

10.1186/s13054-023-04715-z

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

Ines Ziriat, Aurélie Le Thuaut, Gwenhaël Colin, Hamid Merdji, Guillaume Grillet et al. (28 authors)

Annals of Intensive Care2022-10-1714 citations

10.1186/s13613-022-01071-z

Hemodynamics and vasopressor support during targeted temperature management after cardiac arrest with non-shockable rhythm: A post hoc analysis of a randomized controlled trial.

Petit M, Lascarrou JB, Colin G, Merdji H, Cariou A, Geri G, HYPERION investigators.

2022-07-122 citations

10.1016/j.resplu.2022.100271

Targeted Temperature Management for Cardiac Arrest with Nonshockable Rhythm

Jean-Baptiste Lascarrou, Hamid Merdji, Amélie Le Gouge, Gwenhaël Colin, Guillaume Grillet et al. (29 authors)

New England Journal of Medicine2019-10-02622 citations

10.1056/nejmoa1906661

Therapeutic hypothermia after nonshockable cardiac arrest: the HYPERION multicenter, randomized, controlled, assessor-blinded, superiority trial.

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.

2015-03-0723 citations

10.1186/s13049-015-0103-5

Interventions

PROCEDURETargeted 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.

PROCEDURETargeted 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.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
Neurological outcome assessed with Cerebral Performance Category scale	Day 90

Secondary

Measure	Time frame	Description
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
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.
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.
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.

Countries

France, Guadeloupe

Outcome results

None listed