CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 1,380 target
Drug / intervention
Maintain MAP ≥ 90 mmHg +1 moreprocedure
Likely dose
Not stated in record
Key inclusion· 4
  • Out-of-hospital cardiac arrest with initially shockable or non-shockable rhythm admitted to ICU
  • Sustained ROSC for at least 20 minutes with signs of circulation
  • Mechanical ventilation for coma with Glasgow Coma Scale ≤8
  • Consent from relative or emergency procedure inclusion
Key exclusion· 18
  • Age less than 18 years
  • In-hospital cardiac arrest
  • Unwitnessed cardiac arrest with initial asystole rhythm
  • Delay greater than 6 hours between ROSC and randomization attempt

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05486884
NCT05486884N/ARecruitingHigh MomentumUpdated 15mo ago

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

Centre Hospitalier le Mans·interventional·Posted Aug 4, 2022·Updated Mar 26, 2025

In Brief

A clinical study evaluating Maintain MAP ≥ 90 mmHg and Maintain MAP ≥ 65 mmHg for Cardiac Arrest and Out-of-hospital Cardiac Arrest (OHCA). Currently recruiting, targeting 1,380 participants across 27 sites.

Signals

Enrolling ahead of pace

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ARecruiting
202320242025202620272028
First PostedAug 4, 2022
Enrollment StartSep 28, 2024
Primary CompletionMar 28, 2028
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 3.9 years agoPrimary completion in 1.7 years

Interventions

Maintain MAP ≥ 90 mmHgprocedure

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

Maintain MAP ≥ 65 mmHgprocedure

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