Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05486884

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

Led by Centre Hospitalier le Mans · Updated on 2025-03-26

1380

Participants Needed

27

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Out-of-hospital cardiac arrest is a serious health issue with survival rates below 10%. The main cause of death in intensive care units after such an event is post-cardiac arrest syndrome, which leads to shock or brain injury due to lack of oxygen. Brain injury may worsen if blood flow is not properly maintained in the first hours after the heart starts beating again. This research aims to compare two blood pressure targets to see if higher blood pressure after cardiac arrest improves brain function recovery. Participants will be randomly assigned to one of two groups. One group will receive treatment to keep their mean arterial pressure (MAP) at or above 90 mmHg for 24 hours using norepinephrine. The other group will have a standard target MAP of at least 65 mmHg for 24 hours with the same medication. After the initial 24 hours, both groups will aim for MAP of 65 mmHg until they leave the ICU. During the study, patients will be monitored for brain function and survival for up to 180 days. Researchers will evaluate neurological outcomes, survival rates at various points, quality of life, frailty, and kidney function. The study includes measurement of days without ICU stay, ventilator, or kidney therapy. Safety and long-term outcomes will be assessed to understand the effects of different blood pressure targets after cardiac arrest.

CONDITIONS

Brief Title

Mean Arterial Pressure After Out-of-hospital Cardiac Arrest

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Admission to ICU after out-of-hospital cardiac arrest with shockable or non-shockable rhythm
  • Sustained return of spontaneous circulation (ROSC) for at least 20 minutes without chest compressions
  • On invasive mechanical ventilation for coma with Glasgow coma score of 8 or less
  • Consent obtained from a relative or emergency inclusion procedure
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Cardiac arrest occurring in hospital as first event
  • Unwitnessed cardiac arrest with initial rhythm of asystole
  • More than 6 hours between ROSC and randomization attempt
  • Cardiac arrest caused by multiple trauma
  • Cardiac arrest with hemorrhagic shock requiring surgical or radiological hemostasis
  • Cardiac arrest due to acute brain disease such as stroke or severe brain injury
  • Refractory shock defined as MAP below 65 mmHg for over one hour with high dose vasopressors
  • Extracorporeal circulatory support before inclusion
  • Known allergy to norepinephrine or its components
  • Decision to limit care prior to inclusion
  • Modified Rankin score of 4 or 5 before cardiac arrest
  • Participation in another interventional study focused on neurological prognosis
  • Pregnancy or breastfeeding
  • Legal protection status or deprived of freedom
  • Non-French speaking
  • Prior participation in this trial
  • No social security coverage

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 3 weeks or until ICU discharge

Participants receive norepinephrine to maintain a mean arterial pressure (MAP) target. This target is either 90 mmHg or 65 mmHg for the first 24 hours, followed by a MAP target of 65 mmHg until ICU discharge.

Continuous monitoring during ICU stay

Follow-up

Duration - Up to 6 months after inclusion

Participants' health outcomes including survival, neurofunctional status, and quality of life are monitored after ICU discharge up to 6 months.

Visits and assessments at hospital discharge, Day 28, and 6 months after inclusion

Trial Site Locations

Total: 27 locations

1

CHU Brest - Hôpital de La Cavale Blanche

Brest, France, 29609

Actively Recruiting

2

CH Brive

Brive-la-Gaillarde, France, 19100

Actively Recruiting

3

CHU Caen

Caen, France, 14000

Actively Recruiting

4

CH Cholet

Cholet, France, 49300

Actively Recruiting

5

CH Dieppe

Dieppe, France, 76200

Actively Recruiting

6

CHU Dijon - Hôpital F. Mitterrand

Dijon, France, 21079

Actively Recruiting

7

CHD Vendée

La Roche-sur-Yon, France, 85925

Actively Recruiting

8

CH Versailles

Le Chesnay, France, 78150

Not Yet Recruiting

9

Centre Hospitalier Du Mans

Le Mans, France, 72000

Actively Recruiting

10

CH Dr Schaffner

Lens, France, 62300

Actively Recruiting

11

CHU Lille

Lille, France, 59037

Actively Recruiting

12

CHU Limoges

Limoges, France, 87042

Actively Recruiting

13

APHM - Hôpital de la Timone

Marseille, France, 13005

Actively Recruiting

14

Hôpital Jacques Cartier

Massy, France, 91300

Not Yet Recruiting

15

CHU Nantes

Nantes, France, 44093

Not Yet Recruiting

16

CHU Nice - Hôpital Pasteur

Nice, France, 06001

Actively Recruiting

17

CHU Nice - Hôpital Archet

Nice, France, 06202

Actively Recruiting

18

CHU Nîmes

Nîmes, France, 30029

Actively Recruiting

19

CHR Orléans

Orléans, France, 45067

Not Yet Recruiting

20

Hôpital Cochin

Paris, France, 75014

Not Yet Recruiting

21

APHP - Hôpital Européen Georges Pompidou (HEGP)

Paris, France, 75015

Actively Recruiting

22

CHU Poitiers

Poitiers, France, 86021

Actively Recruiting

23

CHU Rennes

Rennes, France, 35000

Actively Recruiting

24

Centre Cardiologique du Nord

Saint-Denis, France, 93207

Actively Recruiting

25

CHRU Strasbourg - Nouvel Hôpital Civil

Strasbourg, France, 67091

Actively Recruiting

26

CHRU Tours - Hôpital Bretonneau

Tours, France, 37044

Actively Recruiting

27

CH Bretagne Atlantique

Vannes, France, 56000

Actively Recruiting

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Research Team

C

Christelle JADEAU

N

Nicolas CHUDEAU

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Mean arterial pressure after out-of-hospital cardiac arrest (METAPHORE): study protocol for a multicentre controlled trial with blinded primary outcome assessor.

Nicolas Chudeau, Patrick Saulnier, Elsa Parot-Schinkel...

https://pubmed.ncbi.nlm.nih.gov/40280607