Comparing Two Blood Pressure Targets After Out-of-hospital Cardiac Arrest to Improve Brain Recovery
Led by Centre Hospitalier le Mans · Updated on 2025-03-26
1380
Participants Needed
27
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Out-of-hospital cardiac arrest is a serious health issue with survival rates below 10%. The main cause of death in intensive care units after such an event is post-cardiac arrest syndrome, which leads to shock or brain injury due to lack of oxygen. Brain injury may worsen if blood flow is not properly maintained in the first hours after the heart starts beating again. This research aims to compare two blood pressure targets to see if higher blood pressure after cardiac arrest improves brain function recovery.
Participants will be randomly assigned to one of two groups. One group will receive treatment to keep their mean arterial pressure MAP at or above 90 mmHg for 24 hours using norepinephrine. The other group will have a standard target MAP of at least 65 mmHg for 24 hours with the same medication. After the initial 24 hours, both groups will aim for MAP of 65 mmHg until they leave the ICU.
During the study, patients will be monitored for brain function and survival for up to 180 days. Researchers will evaluate neurological outcomes, survival rates at various points, quality of life, frailty, and kidney function. The study includes measurement of days without ICU stay, ventilator, or kidney therapy. Safety and long-term outcomes will be assessed to understand the effects of different blood pressure targets after cardiac arrest.
CONDITIONS
Brief Title
Mean Arterial Pressure After Out-of-hospital Cardiac Arrest
Research Team
C
Christelle JADEAU
N
Nicolas CHUDEAU
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Admission to ICU after out-of-hospital cardiac arrest with shockable or non-shockable rhythm
Sustained return of spontaneous circulation (ROSC) for at least 20 minutes without chest compressions
On invasive mechanical ventilation for coma with Glasgow coma score of 8 or less
Consent obtained from a relative or emergency inclusion procedure
You will not qualify if you...
Age under 18 years
Cardiac arrest occurring in hospital as first event
Unwitnessed cardiac arrest with initial rhythm of asystole
More than 6 hours between ROSC and randomization attempt
Cardiac arrest caused by multiple trauma
Cardiac arrest with hemorrhagic shock requiring surgical or radiological hemostasis
Cardiac arrest due to acute brain disease such as stroke or severe brain injury
Refractory shock defined as MAP below 65 mmHg for over one hour with high dose vasopressors
Extracorporeal circulatory support before inclusion
Known allergy to norepinephrine or its components
Decision to limit care prior to inclusion
Modified Rankin score of 4 or 5 before cardiac arrest
Participation in another interventional study focused on neurological prognosis
Pregnancy or breastfeeding
Legal protection status or deprived of freedom
Non-French speaking
Prior participation in this trial
No social security coverage
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 3 weeks or until ICU discharge
Participants receive norepinephrine to maintain a mean arterial pressure (MAP) target. This target is either 90 mmHg or 65 mmHg for the first 24 hours, followed by a MAP target of 65 mmHg until ICU discharge.
Continuous monitoring during ICU stay
Follow-up
Duration - Up to 6 months after inclusion
Participants' health outcomes including survival, neurofunctional status, and quality of life are monitored after ICU discharge up to 6 months.
Visits and assessments at hospital discharge, Day 28, and 6 months after inclusion
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Mean arterial pressure after out-of-hospital cardiac arrest (METAPHORE): study protocol for a multicentre controlled trial with blinded primary outcome assessor.
Nicolas Chudeau, Patrick Saulnier, Elsa Parot-Schinkel...