Mean Arterial Pressure After Out-of-hospital Cardiac Arrest

Last updated: March 21, 2025
Sponsor: Centre Hospitalier le Mans
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Failure

Circulation Disorders

Heart Attack (Myocardial Infarction)

Treatment

Maintain MAP ≥ 65 mmHg

Maintain MAP ≥ 90 mmHg

Clinical Study ID

NCT05486884
CHM-2022/S03/07
  • Ages > 18
  • All Genders

Study Summary

Out-of-hospital cardiac arrest is a public health problem for which overall survival is below 10%. Post-cardiac arrest syndrome is the principal cause of death in intensive care units (ICU), due to refractory shock or brain injuries secondary to anoxia. Brain anoxia is responsible for severe neurological sequelae that may be aggravated by cerebral hypoperfusion during the first few hours after the return of spontaneous circulation. Current recommendations are to ensure that arterial blood pressure is sufficient for the perfusion of organs, but no minimum threshold mean arterial pressure (MAP) has been defined. In practice, most teams target a MAP of at least 65 mmHg. Several observational studies have shown a correlation between MAP and neurological prognosis, patients with a higher initial MAP having a better outcome. Recent pilot studies have demonstrated the feasibility of increasing the target MAP after cardiac arrest, but conflicting results have been obtained concerning patient prognosis. These findings may be explained by changes to the autoregulation of the brain after cardiac arrest, with a shift of the curve towards the right, or its abolition. Cerebral blood flow is dependent on MAP, and a target MAP of 65 mmHg for these patients may result in insufficient brain perfusion. Conversely, a too high MAP might cause brain lesions due to vasogenic edema, hemorrhagic complications or excess perfusion in conditions of diminished brain metabolism. An interventional study is required to evaluate the effect of increasing MAP on neurofunctional outcome after cardiac arrest. Given the data available for brain autoregulation, the correlation between MAP and prognosis, and the risks theoretically associated with a higher MAP, investigator plans to compare a standard threshold of MAP (≥ 65 mmHg) with a high threshold of MAP (≥ 90 mmHg). Investigator hypothesizes that a high MAP within the first 24 hours after cardiac arrest will improve neurofunctional outcome.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Admission to ICU following an out-of-hospital cardiac arrest with an initiallyshockable or non-shockable rhythm ;

  • Sustained ROSC defined as 20 minutes with signs of circulation without the need forchest compressions;

  • Under invasive mechanical ventilation for coma, defined as a Glasgow score ≤ 8/15;

  • Consent from a relative or of a procedure for emergency inclusion.

Exclusion

Exclusion Criteria:

  • Age < 18 years ;

  • In-hospital cardiac arrest (first cardiac arrest);

  • Unwitnessed CA with initial rhythm of asystole

  • Delay between ROSC and attempting randomisation > 6 hours ;

  • Cardiac arrest in a context of multiple trauma ;

  • Cardiac arrest in a context of hemorrhagic shock or severe hemorrhage necessitatinghemostasis (surgery or radiological or endoscopic hemostasis) ;

  • Cardiac arrest secondary to an acute brain disease (ischemic or hemorrhagic stroke,subarachnoid hemorrhage, severe traumatic brain injury) ;

  • Refractory shock :

Defined as a MAP < 65 mmHg for more than one hour on norepinephrine or epinephrine at a dose > 1 µg/kg/min despite adequate fluid resuscitation ;

  • Extracorporeal circulatory support prior to inclusion;

  • Known allergy to norepinephrine or to any of its excipients;

  • Decision to limit care before inclusion ;

  • Modified Rankin score of 4 or 5 before cardiac arrest ;

  • Inclusion in another interventional study in which the principal endpoint isneurological prognosis ;

  • Pregnancy or breast feeding ;

  • Adult patient deprived of freedom or under legal protection (patients underguardianship or curatorship) (article L1121-6 of the French Health Code) ;

  • Non-French speaking;

  • Patient already included in this trial ;

  • Absence of social security cover.

Study Design

Total Participants: 1380
Treatment Group(s): 2
Primary Treatment: Maintain MAP ≥ 65 mmHg
Phase:
Study Start date:
September 28, 2024
Estimated Completion Date:
March 28, 2028

Connect with a study center

  • CHU Brest - Hôpital de La Cavale Blanche

    Brest, 29609
    France

    Active - Recruiting

  • CH Brive

    Brive La Gaillarde, 19100
    France

    Active - Recruiting

  • CHU Caen

    Caen, 14000
    France

    Active - Recruiting

  • CH Cholet

    Cholet, 49300
    France

    Active - Recruiting

  • CH Dieppe

    Dieppe, 76200
    France

    Active - Recruiting

  • CHU Dijon - Hôpital F. Mitterrand

    Dijon, 21079
    France

    Active - Recruiting

  • CHD Vendée

    La Roche-sur-Yon, 85925
    France

    Active - Recruiting

  • CH Versailles

    Le Chesnay, 78150
    France

    Site Not Available

  • Centre Hospitalier Du Mans

    Le Mans, 72000
    France

    Active - Recruiting

  • CH Dr Schaffner

    Lens, 62300
    France

    Active - Recruiting

  • CHU Lille

    Lille, 59037
    France

    Active - Recruiting

  • CHU Limoges

    Limoges, 87042
    France

    Active - Recruiting

  • APHM - Hôpital de la Timone

    Marseille, 13005
    France

    Active - Recruiting

  • Hôpital Jacques Cartier

    Massy, 91300
    France

    Site Not Available

  • CHU Nantes

    Nantes, 44093
    France

    Site Not Available

  • CHU Nice - Hôpital Archet

    Nice, 06202
    France

    Active - Recruiting

  • CHU Nice - Hôpital Pasteur

    Nice, 06001
    France

    Active - Recruiting

  • CHU Nîmes

    Nîmes, 30029
    France

    Active - Recruiting

  • CHR Orléans

    Orléans, 45067
    France

    Site Not Available

  • APHP - Hôpital Européen Georges Pompidou (HEGP)

    Paris, 75015
    France

    Active - Recruiting

  • Hôpital Cochin

    Paris, 75014
    France

    Site Not Available

  • CHU Poitiers

    Poitiers, 86021
    France

    Active - Recruiting

  • CHU Rennes

    Rennes, 35000
    France

    Active - Recruiting

  • Centre Cardiologique du Nord

    Saint-Denis, 93207
    France

    Active - Recruiting

  • CHRU Strasbourg - Nouvel Hôpital Civil

    Strasbourg, 67091
    France

    Active - Recruiting

  • CHRU Tours - Hôpital Bretonneau

    Tours, 37044
    France

    Active - Recruiting

  • CH Bretagne Atlantique

    Vannes, 56000
    France

    Active - Recruiting

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