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Cardiac ArrestMETAPHORENCT05486884

Mean Arterial Pressure After Out-of-hospital Cardiac Arrest

A study testing Maintain MAP ≥ 90 mmHg and Maintain MAP ≥ 65 mmHg in people with Cardiac Arrest and Out-of-hospital Cardiac Arrest (OHCA), run by Centre Hospitalier le Mans at 31 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Maintain MAP ≥ 90 mmHg and Maintain MAP ≥ 65 mmHg
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,380 participants
Where
31 sitesFrance
Study dates
28 Sep 2024to 28 Mar 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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) ;
Show all 19Show fewer
  • 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.

Trial locations and contacts

31 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Christelle JADEAU contact

+33244710781

cjadeau@ch-lemans.fr

Nicolas CHUDEAU contact

+33243432458

nchudeau@ch-lemans.fr

31 sites in 1 country

France31 sites, 31 recruiting

  • CHU Brest - Hôpital de La Cavale Blanche

    Brest, 29609

    Pierre BAILLY, MD, +332 98 34 71 84, pierre.bailly@chu-brest.fr

    Pierre BAILLY, MD

    Recruiting

  • CH Brive

    Brive-la-Gaillarde, 19100

    Nicolas PICHON, MD, +335 55 92 64 79, nicolas.pichon@ch-brive.fr

    Nicolas PICHON, MD

    Recruiting

  • CHU Caen

    Caen, 14000

    Damien DU CHEYRON, PhD, +332 31 06 47 16, ducheyron-d@chu-caen.fr

    Damien DU CHEYRON, PhD

    Recruiting

  • Hopital de Cannes - Simone Veil

    Cannes, 06400

    Pierre ALFONSI BERTRAND, MD, +33492186708, p.alfonsibertrand@ch-cannes.fr

    Pierre ALFONSI BERTRAND

    Not yet recruiting

  • CH Cholet

    Cholet, 49300

    Fabien JAROUSSEAU, MD, +332 41 49 60 87, fabien.jarousseau@ch-lemans.fr

    Fabien JAROUSSEAU, MD

    Recruiting

  • CH Dieppe

    Dieppe, 76200

    Antoine MARCHALOT, MD, +332 32 14 72 53, amarchalot@ch-dieppe.fr

    Antoine MARCHALOT, MD

    Recruiting

  • CHU Dijon - Hôpital F. Mitterrand

    Dijon, 21079

    Jean-Pierre QUENOT, PhD, +333 80 29 36 85, jean-pierre.quenot@chu-dijon.fr

    Jean-Pierre QUENOT, PhD

    Recruiting

  • CHD Vendée

    La Roche-sur-Yon, 85925

    Gwenhael COLIN, MD, +332 51 44 60 35, gwenhael.colin@ght85.fr

    Gwenhael COLIN, MD

    Recruiting

  • CH Versailles

    Le Chesnay, 78150

    Marine PAUL, MD, +331 39 63 83 59, mpaul@ch-versailles.fr

    Marine PAUL, MD

    Recruiting

  • Centre Hospitalier Du Mans

    Le Mans, 72000

    Christelle JADEAU, +33244710781, cjadeau@ch-lemans.fr

    Nicolas CHUDEAU, MD

    Recruiting

  • CH Dr Schaffner

    Lens, 62300

    Olivier NIGEON, MD, +332 21 69 10 88, onigeon@ch-lens.fr

    Olivier NIGEON, MD

    Recruiting

  • CHU Lille

    Lille, 59037

    Patrick GIRARDIE, MD, +333 20 44 64 44, patrick.girardie@chu-lille.fr

    Patrick GIRARDIE, MD

    Recruiting

  • CHU Limoges

    Limoges, 87042

    Marine GOUDELIN, MD, +335 55 05 62 74, Marine.goudelin@chu-limoges.fr

    Marine GOUDELIN, MD

    Recruiting

  • APHM - Hôpital de la Timone

    Marseille, 13005

    Jérémy BOURENNE, MD, +334 13 42 95 66, Jeremy.BOURENNE@ap-hm.fr

    Jérémy BOURENNE, MD

    Recruiting

  • Hôpital Jacques Cartier

    Massy, 91300

    Wulfran BOUGOUIN, PhD, +336 48 03 74 39, wulfran.bougouin@gmail.com

    Wulfran BOUGOUIN, PhD

    Recruiting

  • Hopital Lapeyronie

    Montpellier, Sarthe, 34295

    Boris JUNG, PhD, +33467337736, b-jung@chu-montpellier.fr

    Boris Jung, PhD

    Not yet recruiting

  • CHU Nantes

    Nantes, 44093

    Jean-Baptiste LASCARROU, MD, +332 40 08 73 76, jeanbaptiste.lascarrou@chu-nantes.fr

    Jean-Baptiste LASCARROU, MD

    Recruiting

  • CHU Nice - Hôpital Pasteur

    Nice, 06001

    Denis DOYEN, PhD, +334 92 03 55 10, doyen.d@chu-nice.fr

    Denis DOYEN, PhD

    Recruiting

  • CHU Nice - Hôpital Archet

    Nice, 06202

    Mathieu JOSWIAK, MD, +334 92 03 55 10, joswiak.m@chu-nice.fr

    Mathieu JOSWIAK, MD

    Recruiting

  • CHU Nîmes

    Nîmes, 30029

    Saber Davide BARBAR, MD, +334 66 68 33 20, saber.barbar@chu-nimes.fr

    Saber Davide BARBAR, MD

    Recruiting

  • CHR Orléans

    Orléans, 45067

    Grégoire MULLER, MD, +332 38 51 44 46, gregoire.muller@chr-orleans.fr

    Grégoire MULLER, MD

    Recruiting

  • Hôpital Cochin

    Paris, 75014

    Alain CARIOU, PhD, +331 58 41 25 17, alain.cariou@aphp.fr

    Alain CARIOU, PhD

    Recruiting

  • APHP - Hôpital Européen Georges Pompidou (HEGP)

    Paris, 75015

    Nicolas BRECHOT, PhD, +331 56 09 23 42, nicolas.brechot@aphp.fr

    Nicolas BRECHOT, PhD

    Recruiting

  • Groupe Hospitalier Pitié-Salpêtriere Charles Foix

    Paris, 75651

    Martin DRES, PhD, +33142167797, martin.dres@aphp.fr

    Martin DRES, PhD

    Not yet recruiting

  • CHU Poitiers

    Poitiers, 86021

    Arnaud THILLE, PhD, +335 49 44 43 67, arnaud.THILLE@chu-poitiers.fr

    Arnaud THILLE, PhD

    Recruiting

  • CHU Rennes

    Rennes, 35000

    Benoit PAINVIN, MD, +332 99 28 43 21, benoit.painvin@chu-rennes.fr

    Benoit PAINVIN, MD

    Recruiting

  • Centre Cardiologique du Nord

    Saint-Denis, 93207

    Tristan MORICHAU-BEAUCHANT, MD, +331 49 33 48 91, t.morichau-beauchant@ccn.fr

    Tristan MORICHAU-BEAUCHANT, MD

    Recruiting

  • Centre hospitalier Saint Nazaire

    Saint-Nazaire, 44600

    Julien LORBER, +33272278739, j.lorber@ch-saintnazaire.fr

    Julien LORBER

    Recruiting

  • CHRU Strasbourg - Nouvel Hôpital Civil

    Strasbourg, 67091

    Hamid MERDJI, MD, +333 69 55 11 23, hamid.merdji@chru-strasbourg.fr

    Hamid MERDJI, MD

    Recruiting

  • CHRU Tours - Hôpital Bretonneau

    Tours, 37044

    Charlotte SALMON GANDONNIERE, MD, +332 47 47 38 55, charlotte.salmon@univ-tours.fr

    Charlotte SALMON GANDONNIERE, MD

    Recruiting

  • CH Bretagne Atlantique

    Vannes, 56000

    Agathe DELBOVE, MD, +332 97 01 43 06, agathe.delbove@ch-bretagne-atlantique.fr

    Agathe DELBOVE, MD

    Recruiting

Other trials in France

About this study

Official title: Mean Arterial Pressure After Out-of-hospital Cardiac Arrest: the METAPHORE Randomized Trial

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.

Being tested
Maintain MAP ≥ 90 mmHg, Maintain MAP ≥ 65 mmHg
Keywords
cardiac arrest, outcome, cerebral blood flow, mean arterial pressure
Medical subject headings
Heart Arrest, Out-of-Hospital Cardiac Arrest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Maintain MAP ≥ 90 mmHgProcedure or surgery

    Maintain MAP ≥ 90 mmHg for the 24 hours following inclusion by perfusion of norepinephrine

  • Maintain MAP ≥ 65 mmHgProcedure or surgery

    Maintain MAP ≥ 65 mmHg for 24 hours after randomization through the perfusion of norepinephrine

Study groups in NCT05486884
Study groupRoleWhat they receive
high MAP thresholdExperimentalNorepinephrine will be titrated to maintain MAP ≥ 90 mmHg. This threshold will be maintained for the 24 hours following inclusion by the perfusion of norepinephrine at an appropriate dose. From 24 hours after inclusion until ICU discharge, a MAP ≥ 65 mmHg will be targeted
Receives: Procedure: Maintain MAP ≥ 90 mmHg
standard MAP thresholdActive comparatorNorepinephrine will be titrated to maintain MAP ≥ 65 mmHg. This target MAP will be maintained for 24 hours after randomization through the perfusion of norepinephrine at an appropriate flow rate. From 24 hours after inclusion until ICU discharge, a MAP ≥ 65 mmHg will be targeted
Receives: Procedure: Maintain MAP ≥ 65 mmHg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with a good neurofunctional outcome 180 days after inclusion

    Good neurofunctional outcome will be defined by a modified Rankin scale (mRS) of 0 to 3.This score is a global evaluation scale for disability, with seven levels (0 = no symptoms; 6 = patient dead).This score will be measured by psychologist who will be blinded to the randomization arm.

    Measured: 180 days after inclusion

Secondary outcomes (7)

  1. Proportion of patients alive at Intensive Care Unit discharge, at hospital discharge, at day 28 (D28) and six months (D180) after inclusion

    Proportion of patients alive at Intensive Care Unit discharge, at hospital discharge, at day 28 (D28) and six months (D180) after inclusion

    Measured: From Intensive Care Unit admission to Intensive Care Unit discharge (up to 3 weeks), from hospital admission to hospital discharge (up to 12 weeks), 28 days and 180 days after inclusion

  2. Proportion of patients alive at Intensive Care Unit discharge with good neurofunctionnal outcome

    Good neurofunctional outcome will be defined by a modified Rankin scale (mRS) of 0 to 3.This score is a global evaluation scale for disability, with seven levels (0 = no symptoms; 6 = patient dead

    Measured: From Intensive Care Unit admission to Intensive Care Unit discharge (up to 3 weeks)

  3. Quality of life six months after inclusion

    Quality of life is measured by EuroQol-5D-5L. It's a measure of health-related quality of life and comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). EuroQol-5D-5L could be administered by telephone

    Measured: 6 months after inclusion

  4. Evaluation of Clinical Frailty at six months after inclusion

    Clinical Frailty is measured by the Clinical Frailty Scale (CFS). It summarizes the overall level of fitness or frailty of a patient with a score from 1 (very fit) to 9 (terminally ill)

    Measured: Six months after inclusion

  5. Number of ICU-free days at Day 28

    Number of ICU-free days is calculated from the number of days alive outside the ICU by Day 28

    Measured: Day 28

  6. Number of ventilator-free days, number of catecholamine-free days and number of renal replacement therapy-free days at day 28

    Number of ventilator-free days, number of catecholamine-free days and number of renal replacement therapy-free days is calculated from the number of days alive without invasive mechanical ventilation, catecholamine infusion or renal replacement therapy by Day 28

    Measured: 28 days after inclusion

  7. Proportion of patients with acute kidney injury stage 3 and need for renal replacement therapy (RRT) within Intensive Care Unit stay and persistant need for RRT at Intensive Care Unit discharge

    Acute kidney injury stage 3 is defined by at least one of the following criteria: serum creatinine concentration of more than 4 mg/dl (354 µmol/liter) or greater than 3 times the baseline creatinine level, anuria (urine output of 100 ml/day or less) for more than 12 hours, oliguria (urine output below 0.3 ml/kg/h or below 500 ml/day) for more than 24 hours;

    Measured: From Intensive Care Unit admission to Intensive Care Unit discharge (up to 3 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2022
  2. Study start28 Sep 2024
  3. Primary completion28 Mar 2028 (estimated)
  4. Study completion28 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, multicenter, randomized, controlled, open study
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,380 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05486884
Sponsor's protocol ID
CHM-2022/S03/07
Acronym
METAPHORE
Status last verified
Sep 2026
First submitted
2 Aug 2022
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: After publication of the main results, the anonymized data necessary for carrying out additional analyses may be made available upon request addressed to the coordinating investigator and the scientific committee

Publications

  • Chudeau N, Saulnier P, Parot-Schinkel E, Lascarrou JB, Colin G, Barbar SD, Painvin B, Pichon N, Du Cheyron D, Marchalot A, Jarousseau F, Delbove A, Morichau-Beauchant T, Girardie P, Salmon Gandonniere C, Thille AW, Quenot JP, Bailly P, Goudelin M, Martino F, Nigeon O, Merdji H, Brechot N, Bourenne J, Bougouin W, Muller G, Jozwiak M, Doyen D, Rouanet E, Cariou A, Guitton C; AfterROSC Network; CRICS TRIGGERSep F-CRIN Network. Mean arterial pressure after out-of-hospital cardiac arrest (METAPHORE): study protocol for a multicentre controlled trial with blinded primary outcome assessor. BMJ Open. 2025 Apr 25;15(4):e096997. doi: 10.1136/bmjopen-2024-096997.

    PubMed 40280607

Questions about this trial

What is this clinical trial studying?

A study testing Maintain MAP ≥ 90 mmHg and Maintain MAP ≥ 65 mmHg in people with Cardiac Arrest and Out-of-hospital Cardiac Arrest (OHCA), run by Centre Hospitalier le Mans at 31 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Christelle JADEAU (+33244710781, cjadeau@ch-lemans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with a good neurofunctional outcome 180 days after inclusion (time frame: 180 days after inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05486884, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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