Effects of mean arterial pressure on outcomes after out-of-hospital cardiac arrest
Mean Arterial Pressure After Out-of-hospital Cardiac Arrest: the METAPHORE Randomized Trial
This study tests if keeping blood pressure at a higher level after a cardiac arrest can help patients recover better and survive longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1380 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier le Mans Academic / other |
| Locations | 27 sites (Brest and 26 other locations) |
| Trial ID | NCT05486884 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of maintaining different levels of mean arterial pressure (MAP) on patients who have experienced out-of-hospital cardiac arrest. The study aims to determine whether targeting a higher MAP of 90 mmHg, compared to the standard 65 mmHg, can improve neurological outcomes and overall survival rates. Patients will be monitored in the intensive care unit (ICU) after achieving return of spontaneous circulation (ROSC) and will be assessed for their neurological status and recovery. The trial seeks to clarify the optimal MAP threshold for post-cardiac arrest care.
Who should consider this trial
Good fit: Ideal candidates include adults who have been admitted to the ICU following an out-of-hospital cardiac arrest with sustained ROSC and are under invasive mechanical ventilation for coma.
Not a fit: Patients under 18 years old, those with in-hospital cardiac arrest, or those with specific contraindications such as severe hemorrhage or acute brain disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved survival and neurological outcomes for patients who suffer from out-of-hospital cardiac arrest.
How similar studies have performed: Previous observational studies have shown a correlation between MAP and neurological prognosis, indicating that this approach has some supportive evidence, although the specific higher MAP target is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Brest and 26 other locations
- CHU Brest - Hôpital de La Cavale Blanche — Brest, France (Recruiting)
- CH Brive — Brive-la-Gaillarde, France (Recruiting)
- CHU Caen — Caen, France (Recruiting)
- CH Cholet — Cholet, France (Recruiting)
- CH Dieppe — Dieppe, France (Recruiting)
- CHU Dijon - Hôpital F. Mitterrand — Dijon, France (Recruiting)
- CHD Vendée — La Roche-sur-Yon, France (Recruiting)
- CH Versailles — Le Chesnay, France (Not_yet_recruiting)
- Centre Hospitalier Du Mans — Le Mans, France (Recruiting)
- CH Dr Schaffner — Lens, France (Recruiting)
- CHU Lille — Lille, France (Recruiting)
- CHU Limoges — Limoges, France (Recruiting)
- APHM - Hôpital de la Timone — Marseille, France (Recruiting)
- Hôpital Jacques Cartier — Massy, France (Not_yet_recruiting)
- CHU Nantes — Nantes, France (Not_yet_recruiting)
- CHU Nice - Hôpital Pasteur — Nice, France (Recruiting)
- CHU Nice - Hôpital Archet — Nice, France (Recruiting)
- CHU Nîmes — Nîmes, France (Recruiting)
- CHR Orléans — Orléans, France (Not_yet_recruiting)
- Hôpital Cochin — Paris, France (Not_yet_recruiting)
- APHP - Hôpital Européen Georges Pompidou (HEGP) — Paris, France (Recruiting)
- CHU Poitiers — Poitiers, France (Recruiting)
- CHU Rennes — Rennes, France (Recruiting)
- Centre Cardiologique du Nord — Saint-Denis, France (Recruiting)
- CHRU Strasbourg - Nouvel Hôpital Civil — Strasbourg, France (Recruiting)
- CHRU Tours - Hôpital Bretonneau — Tours, France (Recruiting)
- CH Bretagne Atlantique — Vannes, France (Recruiting)
Study contacts
- Study coordinator: Christelle JADEAU
- Email: cjadeau@ch-lemans.fr
- Phone: +33244710781
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.