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RECRUITING
NCT05486884
NA

Mean Arterial Pressure After Out-of-hospital Cardiac Arrest

Sponsor: Centre Hospitalier le Mans

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1380

Start Date

2024-09-28

Completion Date

2028-03-28

Last Updated

2025-03-26

Healthy Volunteers

No

Interventions

PROCEDURE

Maintain MAP ≥ 90 mmHg

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

PROCEDURE

Maintain MAP ≥ 65 mmHg

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

Locations (27)

CHU Brest - Hôpital de La Cavale Blanche

Brest, France

CH Brive

Brive-la-Gaillarde, France

CHU Caen

Caen, France

CH Cholet

Cholet, France

CH Dieppe

Dieppe, France

CHU Dijon - Hôpital F. Mitterrand

Dijon, France

CHD Vendée

La Roche-sur-Yon, France

CH Versailles

Le Chesnay, France

Centre Hospitalier Du Mans

Le Mans, France

CH Dr Schaffner

Lens, France

CHU Lille

Lille, France

CHU Limoges

Limoges, France

APHM - Hôpital de la Timone

Marseille, France

Hôpital Jacques Cartier

Massy, France

CHU Nantes

Nantes, France

CHU Nice - Hôpital Pasteur

Nice, France

CHU Nice - Hôpital Archet

Nice, France

CHU Nîmes

Nîmes, France

CHR Orléans

Orléans, France

Hôpital Cochin

Paris, France

APHP - Hôpital Européen Georges Pompidou (HEGP)

Paris, France

CHU Poitiers

Poitiers, France

CHU Rennes

Rennes, France

Centre Cardiologique du Nord

Saint-Denis, France

CHRU Strasbourg - Nouvel Hôpital Civil

Strasbourg, France

CHRU Tours - Hôpital Bretonneau

Tours, France

CH Bretagne Atlantique

Vannes, France