Informations générales (source: ClinicalTrials.gov)
Mean Arterial Pressure After Out-of-hospital Cardiac Arrest: the METAPHORE Randomized Trial
Interventional
N/A
Centre Hospitalier le Mans (Voir sur ClinicalTrials)
septembre 2024
mars 2028
10 septembre 2026
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Cochin | Alain CARIOU, PhD | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Europeen Georges Pompidou | Nicolas BRECHOT, PhD | Contact (sur clinicalTrials) | |||
| CENTRE CARDIOLOGIQUE DU NORD | Tristan MORICHAU-BEAUCHANT, MD | Contact (sur clinicalTrials) | |||
| CH DE VERSAILLES SITE ANDRE MIGNOT | Marine PAUL, MD | Contact (sur clinicalTrials) | |||
| IFSI DU GROUPE HOSP. PITIÉ SALPÉTRIÈRE | Martin DRES, PhD | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CH Bretagne Atlantique - 56000 - Vannes - France | Agathe DELBOVE, MD | Contact (sur clinicalTrials) | |||
| CHR Orléans - 45067 - Orléans - France | Grégoire MULLER, MD | Contact (sur clinicalTrials) | |||
| CHRU Strasbourg - Nouvel Hôpital Civil - 67091 - Strasbourg - France | Hamid MERDJI, MD | Contact (sur clinicalTrials) | |||
| CHU Brest - Hôpital de La Cavale Blanche - 29609 - Brest - France | Pierre BAILLY, MD | Contact (sur clinicalTrials) | |||
| CHU Dijon - Hôpital F. Mitterrand - 21079 - Dijon - France | Jean-Pierre QUENOT, PhD | Contact (sur clinicalTrials) | |||
| CHU Nice - Hôpital Archet - 06202 - Nice - France | Mathieu JOSWIAK, MD | Contact (sur clinicalTrials) | |||
| CHU Nice - Hôpital Pasteur - 06001 - Nice - France | Denis DOYEN, PhD | Contact (sur clinicalTrials) | |||
| CHU Nîmes - 30029 - Nîmes - France | Saber Davide BARBAR, MD | Contact (sur clinicalTrials) | |||
| CHU Poitiers - 86021 - Poitiers - France | Arnaud THILLE, PhD | Contact (sur clinicalTrials) | |||
| CHU Rennes - 35000 - Rennes - France | Benoit PAINVIN, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| APHM - Hôpital de la Timone - 13005 - Marseille - France | Jérémy BOURENNE, MD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Du Mans - 72000 - Le Mans - France | Christelle JADEAU | Contact (sur clinicalTrials) | |||
| Centre hospitalier Saint Nazaire - 44600 - Saint-Nazaire - France | Julien LORBER | Contact (sur clinicalTrials) | |||
| CH Brive - 19100 - Brive-la-Gaillarde - France | Nicolas PICHON, MD | Contact (sur clinicalTrials) | |||
| CH Cholet - 49300 - Cholet - France | Fabien JAROUSSEAU, MD | Contact (sur clinicalTrials) | |||
| CH Dieppe - 76200 - Dieppe - France | Antoine MARCHALOT, MD | Contact (sur clinicalTrials) | |||
| CH Dr Schaffner - 62300 - Lens - France | Olivier NIGEON, MD | Contact (sur clinicalTrials) | |||
| CHD Vendée - 85925 - La Roche-sur-Yon - France | Gwenhael COLIN, MD | Contact (sur clinicalTrials) | |||
| CHRU Tours - Hôpital Bretonneau - 37044 - Tours - France | Charlotte SALMON GANDONNIERE, MD | Contact (sur clinicalTrials) | |||
| CHU Caen - 14000 - Caen - France | Damien DU CHEYRON, PhD | Contact (sur clinicalTrials) | |||
| CHU Lille - 59037 - Lille - France | Patrick GIRARDIE, MD | Contact (sur clinicalTrials) | |||
| CHU Limoges - 87042 - Limoges - France | Marine GOUDELIN, MD | Contact (sur clinicalTrials) | |||
| CHU Nantes - 44093 - Nantes - France | Jean-Baptiste LASCARROU, MD | Contact (sur clinicalTrials) | |||
| Hopital de Cannes - Simone Veil - 06400 - Cannes - France | Pierre ALFONSI BERTRAND, MD | Contact (sur clinicalTrials) | |||
| Hôpital Jacques Cartier - 91300 - Massy - France | Wulfran BOUGOUIN, PhD | Contact (sur clinicalTrials) | |||
| Hopital Lapeyronie - 34295 - Montpellier - Sarthe - France | Boris JUNG, PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
- 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.