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Mean Arterial Pressure After Out-of-hospital Cardiac Arrest

NCT ID: NCT05486884

Last Updated: 2025-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-28

Study Completion Date

2028-03-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiac Arrest Out-of-hospital Cardiac Arrest (OHCA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, multicenter, randomized, controlled, open study
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Score mRS will be measured by a psychologist during a telephone interview 180 days after inclusion. The psychologist will be blinded to the randomization arm

Study Groups

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high MAP threshold

Norepinephrine 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

Group Type EXPERIMENTAL

Maintain MAP ≥ 90 mmHg

Intervention Type PROCEDURE

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

standard MAP threshold

Norepinephrine 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

Group Type ACTIVE_COMPARATOR

Maintain MAP ≥ 65 mmHg

Intervention Type PROCEDURE

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

Interventions

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Maintain MAP ≥ 90 mmHg

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

Intervention Type PROCEDURE

Maintain MAP ≥ 65 mmHg

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier le Mans

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Brest - Hôpital de La Cavale Blanche

Brest, , France

Site Status RECRUITING

CH Brive

Brive-la-Gaillarde, , France

Site Status RECRUITING

CHU Caen

Caen, , France

Site Status RECRUITING

CH Cholet

Cholet, , France

Site Status RECRUITING

CH Dieppe

Dieppe, , France

Site Status RECRUITING

CHU Dijon - Hôpital F. Mitterrand

Dijon, , France

Site Status RECRUITING

CHD Vendée

La Roche-sur-Yon, , France

Site Status RECRUITING

CH Versailles

Le Chesnay, , France

Site Status NOT_YET_RECRUITING

Centre Hospitalier Du Mans

Le Mans, , France

Site Status RECRUITING

CH Dr Schaffner

Lens, , France

Site Status RECRUITING

CHU Lille

Lille, , France

Site Status RECRUITING

CHU Limoges

Limoges, , France

Site Status RECRUITING

APHM - Hôpital de la Timone

Marseille, , France

Site Status RECRUITING

Hôpital Jacques Cartier

Massy, , France

Site Status NOT_YET_RECRUITING

CHU Nantes

Nantes, , France

Site Status NOT_YET_RECRUITING

CHU Nice - Hôpital Pasteur

Nice, , France

Site Status RECRUITING

CHU Nice - Hôpital Archet

Nice, , France

Site Status RECRUITING

CHU Nîmes

Nîmes, , France

Site Status RECRUITING

CHR Orléans

Orléans, , France

Site Status NOT_YET_RECRUITING

Hôpital Cochin

Paris, , France

Site Status NOT_YET_RECRUITING

APHP - Hôpital Européen Georges Pompidou (HEGP)

Paris, , France

Site Status RECRUITING

CHU Poitiers

Poitiers, , France

Site Status RECRUITING

CHU Rennes

Rennes, , France

Site Status RECRUITING

Centre Cardiologique du Nord

Saint-Denis, , France

Site Status RECRUITING

CHRU Strasbourg - Nouvel Hôpital Civil

Strasbourg, , France

Site Status RECRUITING

CHRU Tours - Hôpital Bretonneau

Tours, , France

Site Status RECRUITING

CH Bretagne Atlantique

Vannes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Christelle JADEAU

Role: CONTACT

[email protected]
+33244710781

Nicolas CHUDEAU

Role: CONTACT

[email protected]
+33243432458

Facility Contacts

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Pierre BAILLY, MD

Role: primary

[email protected]
+332 98 34 71 84

Nicolas PICHON, MD

Role: primary

[email protected]
+335 55 92 64 79

Damien DU CHEYRON, PhD

Role: primary

[email protected]
+332 31 06 47 16

Fabien JAROUSSEAU, MD

Role: primary

[email protected]
+332 41 49 60 87

Antoine MARCHALOT, MD

Role: primary

[email protected]
+332 32 14 72 53

Jean-Pierre QUENOT, PhD

Role: primary

[email protected]
+333 80 29 36 85

Gwenhael COLIN, MD

Role: primary

[email protected]
+332 51 44 60 35

Marine PAUL, MD

Role: primary

[email protected]
+331 39 63 83 59

Christelle JADEAU

Role: primary

[email protected]
+33244710781

Olivier NIGEON, MD

Role: primary

[email protected]
+332 21 69 10 88

Patrick GIRARDIE, MD

Role: primary

[email protected]
+333 20 44 64 44

Marine GOUDELIN, MD

Role: primary

[email protected]
+335 55 05 62 74

Jérémy BOURENNE, MD

Role: primary

[email protected]
+334 13 42 95 66

Wulfran BOUGOUIN, PhD

Role: primary

[email protected]
+336 48 03 74 39

Jean-Baptiste LASCARROU, MD

Role: primary

[email protected]
+332 40 08 73 76

Denis DOYEN, PhD

Role: primary

[email protected]
+334 92 03 55 10

Mathieu JOSWIAK, MD

Role: primary

[email protected]
+334 92 03 55 10

Saber Davide BARBAR, MD

Role: primary

[email protected]
+334 66 68 33 20

Grégoire MULLER, MD

Role: primary

[email protected]
+332 38 51 44 46

Alain CARIOU, PhD

Role: primary

[email protected]
+331 58 41 25 17

Nicolas BRECHOT, PhD

Role: primary

[email protected]
+331 56 09 23 42

Arnaud THILLE, PhD

Role: primary

[email protected]
+335 49 44 43 67

Benoit PAINVIN, MD

Role: primary

[email protected]
+332 99 28 43 21

Tristan MORICHAU-BEAUCHANT, MD

Role: primary

[email protected]
+331 49 33 48 91

Hamid MERDJI, MD

Role: primary

[email protected]
+333 69 55 11 23

Charlotte SALMON GANDONNIERE, MD

Role: primary

[email protected]
+332 47 47 38 55

Agathe DELBOVE, MD

Role: primary

[email protected]
+332 97 01 43 06

References

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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.

Reference Type DERIVED
PMID: 40280607 (View on PubMed)

Other Identifiers

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CHM-2022/S03/07

Identifier Type: -

Identifier Source: org_study_id

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