Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05486884

Mean Arterial Pressure After Out-of-hospital Cardiac Arrest

Led by Centre Hospitalier le Mans · Updated on 2025-03-26

1380

Participants Needed

27

Research Sites

182 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Mean Arterial Pressure After Out-of-hospital Cardiac Arrest

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Admission to ICU following an out-of-hospital cardiac arrest with an initially shockable or non-shockable rhythm
  • Sustained return of spontaneous circulation (ROSC) defined as 20 minutes with signs of circulation without chest compressions
  • Under invasive mechanical ventilation for coma, defined as a Glasgow score 64 8/15
  • Consent from a relative or emergency inclusion procedure
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • In-hospital cardiac arrest (first cardiac arrest)
  • Unwitnessed cardiac arrest with initial rhythm of asystole
  • Delay between ROSC and randomization attempt greater than 6 hours
  • Cardiac arrest due to multiple trauma
  • Cardiac arrest due to hemorrhagic shock or severe hemorrhage requiring hemostasis
  • Cardiac arrest secondary to acute brain disease (ischemic or hemorrhagic stroke, subarachnoid hemorrhage, severe traumatic brain injury)
  • Refractory shock defined as MAP under 65 mmHg for more than one hour on norepinephrine or epinephrine over 1 bcg/kg/min despite fluids
  • Extracorporeal circulatory support prior to inclusion
  • Known allergy to norepinephrine or its excipients
  • Decision to limit care before inclusion
  • Modified Rankin score of 4 or 5 before cardiac arrest
  • Inclusion in another interventional study focused on neurological prognosis
  • Pregnancy or breastfeeding
  • Adult patient deprived of freedom or under legal protection
  • Non-French speaking
  • Patient already included in this trial
  • Absence of social security cover

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 27 locations

1

CHU Brest - Hôpital de La Cavale Blanche

Brest, France, 29609

Actively Recruiting

2

CH Brive

Brive-la-Gaillarde, France, 19100

Actively Recruiting

3

CHU Caen

Caen, France, 14000

Actively Recruiting

4

CH Cholet

Cholet, France, 49300

Actively Recruiting

5

CH Dieppe

Dieppe, France, 76200

Actively Recruiting

6

CHU Dijon - Hôpital F. Mitterrand

Dijon, France, 21079

Actively Recruiting

7

CHD Vendée

La Roche-sur-Yon, France, 85925

Actively Recruiting

8

CH Versailles

Le Chesnay, France, 78150

Not Yet Recruiting

9

Centre Hospitalier Du Mans

Le Mans, France, 72000

Actively Recruiting

10

CH Dr Schaffner

Lens, France, 62300

Actively Recruiting

11

CHU Lille

Lille, France, 59037

Actively Recruiting

12

CHU Limoges

Limoges, France, 87042

Actively Recruiting

13

APHM - Hôpital de la Timone

Marseille, France, 13005

Actively Recruiting

14

Hôpital Jacques Cartier

Massy, France, 91300

Not Yet Recruiting

15

CHU Nantes

Nantes, France, 44093

Not Yet Recruiting

16

CHU Nice - Hôpital Pasteur

Nice, France, 06001

Actively Recruiting

17

CHU Nice - Hôpital Archet

Nice, France, 06202

Actively Recruiting

18

CHU Nîmes

Nîmes, France, 30029

Actively Recruiting

19

CHR Orléans

Orléans, France, 45067

Not Yet Recruiting

20

Hôpital Cochin

Paris, France, 75014

Not Yet Recruiting

21

APHP - Hôpital Européen Georges Pompidou (HEGP)

Paris, France, 75015

Actively Recruiting

22

CHU Poitiers

Poitiers, France, 86021

Actively Recruiting

23

CHU Rennes

Rennes, France, 35000

Actively Recruiting

24

Centre Cardiologique du Nord

Saint-Denis, France, 93207

Actively Recruiting

25

CHRU Strasbourg - Nouvel Hôpital Civil

Strasbourg, France, 67091

Actively Recruiting

26

CHRU Tours - Hôpital Bretonneau

Tours, France, 37044

Actively Recruiting

27

CH Bretagne Atlantique

Vannes, France, 56000

Actively Recruiting

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Research Team

C

Christelle JADEAU

CONTACT

N

Nicolas CHUDEAU

CONTACT

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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Mean Arterial Pressure After Out-of-hospital Cardiac Arrest | DecenTrialz