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Mean arterial pressure after out-of-hospital cardiac arrest: the METAPHORE randomized trial

NCT ID NCT05486884

NEW Sponsor: Centre Hospitalier le Mans Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 09, 2026

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,380 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Admission to ICU following an out-of-hospital cardiac arrest with an initially shockable or non-shockable rhythm ; * Sustained ROSC defined as 20 minutes with signs of circulation without the need for chest 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 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 necessitating hemostasis (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 is neurological prognosis ; * Pregnancy or breast feeding ; * Adult patient deprived of freedom or under legal protection (patients under guardianship or curatorship) (article L1121-6 of the French Health Code) ; * Non-French speaking; * Patient already included in this trial ; * Absence of social security cover.

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Conditions

The condition(s) this trial relates to.

cardiac arrest Out-of-Hospital Cardiac Arrest

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiac arrest Out-of-hospital cardiac arrest (OHCA)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    31 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • APHM - Hôpital de la Timone

    RECRUITING

    Marseille, 13005, France

  • APHP - Hôpital Européen Georges Pompidou (HEGP)

    RECRUITING

    Paris, 75015, France

  • CH Bretagne Atlantique

    RECRUITING

    Vannes, 56000, France

  • CH Brive

    RECRUITING

    Brive-la-Gaillarde, 19100, France

  • CH Cholet

    RECRUITING

    Cholet, 49300, France

  • CH Dieppe

    RECRUITING

    Dieppe, 76200, France

  • CH Dr Schaffner

    RECRUITING

    Lens, 62300, France

  • CH Versailles

    RECRUITING

    Le Chesnay, 78150, France

  • CHD Vendée

    RECRUITING

    La Roche-sur-Yon, 85925, France

  • CHR Orléans

    RECRUITING

    Orléans, 45067, France

  • CHRU Strasbourg - Nouvel Hôpital Civil

    RECRUITING

    Strasbourg, 67091, France

  • CHRU Tours - Hôpital Bretonneau

    RECRUITING

    Tours, 37044, France

  • CHU Brest - Hôpital de La Cavale Blanche

    RECRUITING

    Brest, 29609, France

  • CHU Caen

    RECRUITING

    Caen, 14000, France

  • CHU Dijon - Hôpital F. Mitterrand

    RECRUITING

    Dijon, 21079, France

  • CHU Lille

    RECRUITING

    Lille, 59037, France

  • CHU Limoges

    RECRUITING

    Limoges, 87042, France

  • CHU Nantes

    RECRUITING

    Nantes, 44093, France

  • CHU Nice - Hôpital Archet

    RECRUITING

    Nice, 06202, France

  • CHU Nice - Hôpital Pasteur

    RECRUITING

    Nice, 06001, France

  • CHU Nîmes

    RECRUITING

    Nîmes, 30029, France

  • CHU Poitiers

    RECRUITING

    Poitiers, 86021, France

  • CHU Rennes

    RECRUITING

    Rennes, 35000, France

  • Centre Cardiologique du Nord

    RECRUITING

    Saint-Denis, 93207, France

  • Centre Hospitalier Du Mans

    RECRUITING

    Le Mans, 72000, France

  • Centre hospitalier Saint Nazaire

    RECRUITING

    Saint-Nazaire, 44600, France

  • Groupe Hospitalier Pitié-Salpêtriere Charles Foix

    NOT_YET_RECRUITING

    Paris, 75651, France

  • Hopital Lapeyronie

    NOT_YET_RECRUITING

    Montpellier, Sarthe, 34295, France

  • Hopital de Cannes - Simone Veil

    NOT_YET_RECRUITING

    Cannes, 06400, France

  • Hôpital Cochin

    RECRUITING

    Paris, 75014, France

  • Hôpital Jacques Cartier

    RECRUITING

    Massy, 91300, France

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