An interventional study of Maintain MAP ≥ 90 mmHg and Maintain MAP ≥ 65 mmHg in Cardiac Arrest and Out-of-hospital Cardiac Arrest (OHCA), sponsored by Centre Hospitalier le Mans. Recruiting at 31 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Centre Hospitalier le Mans · Not applicable, Interventional, and Treatment
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.
314 studies on the registry are indexed under Out-of-Hospital Cardiac Arrest; 93 are open to participants now.
This study's planned enrollment of 1,380 is above the median of 218 across 179 interventional studies indexed under Out-of-Hospital Cardiac Arrest.
Browse Out-of-Hospital Cardiac Arrest studies →Centre Hospitalier le Mans is the lead sponsor of 44 studies on the registry; 18 are open to participants now.
Compared within Out-of-Hospital Cardiac Arrest, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Heart Arrest. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
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 ;
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Norepinephrine will be titrated to maintain MAP ≥ 90 mmHg. This threshold will be maintained for the 24 hours following inclusion by the perfusion of norepinephrine at an appropriate dose. From 24 hours after inclusion until ICU discharge, a MAP ≥ 65 mmHg will be targeted
Procedure: Maintain MAP ≥ 90 mmHg
Norepinephrine will be titrated to maintain MAP ≥ 65 mmHg. This target MAP will be maintained for 24 hours after randomization through the perfusion of norepinephrine at an appropriate flow rate. From 24 hours after inclusion until ICU discharge, a MAP ≥ 65 mmHg will be targeted
Procedure: Maintain MAP ≥ 65 mmHg
Maintain MAP ≥ 90 mmHg for the 24 hours following inclusion by perfusion of norepinephrine
Maintain MAP ≥ 65 mmHg for 24 hours after randomization through the perfusion of norepinephrine
Proportion of patients with a good neurofunctional outcome 180 days after inclusion
Good neurofunctional outcome will be defined by a modified Rankin scale (mRS) of 0 to 3.This score is a global evaluation scale for disability, with seven levels (0 = no symptoms; 6 = patient dead).This score will be measured by psychologist who will be blinded to the randomization arm.
Time frame: 180 days after inclusion
Proportion of patients alive at Intensive Care Unit discharge, at hospital discharge, at day 28 (D28) and six months (D180) after inclusion
Proportion of patients alive at Intensive Care Unit discharge, at hospital discharge, at day 28 (D28) and six months (D180) after inclusion
Time frame: From Intensive Care Unit admission to Intensive Care Unit discharge (up to 3 weeks), from hospital admission to hospital discharge (up to 12 weeks), 28 days and 180 days after inclusion
Proportion of patients alive at Intensive Care Unit discharge with good neurofunctionnal outcome
Good neurofunctional outcome will be defined by a modified Rankin scale (mRS) of 0 to 3.This score is a global evaluation scale for disability, with seven levels (0 = no symptoms; 6 = patient dead
Time frame: From Intensive Care Unit admission to Intensive Care Unit discharge (up to 3 weeks)
Quality of life six months after inclusion
Quality of life is measured by EuroQol-5D-5L. It's a measure of health-related quality of life and comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). EuroQol-5D-5L could be administered by telephone
Time frame: 6 months after inclusion
Evaluation of Clinical Frailty at six months after inclusion
Clinical Frailty is measured by the Clinical Frailty Scale (CFS). It summarizes the overall level of fitness or frailty of a patient with a score from 1 (very fit) to 9 (terminally ill)
Time frame: Six months after inclusion
Number of ICU-free days at Day 28
Number of ICU-free days is calculated from the number of days alive outside the ICU by Day 28
Time frame: Day 28
Number of ventilator-free days, number of catecholamine-free days and number of renal replacement therapy-free days at day 28
Number of ventilator-free days, number of catecholamine-free days and number of renal replacement therapy-free days is calculated from the number of days alive without invasive mechanical ventilation, catecholamine infusion or renal replacement therapy by Day 28
Time frame: 28 days after inclusion
Proportion of patients with acute kidney injury stage 3 and need for renal replacement therapy (RRT) within Intensive Care Unit stay and persistant need for RRT at Intensive Care Unit discharge
Acute kidney injury stage 3 is defined by at least one of the following criteria: serum creatinine concentration of more than 4 mg/dl (354 µmol/liter) or greater than 3 times the baseline creatinine level, anuria (urine output of 100 ml/day or less) for more than 12 hours, oliguria (urine output below 0.3 ml/kg/h or below 500 ml/day) for more than 24 hours;
Time frame: From Intensive Care Unit admission to Intensive Care Unit discharge (up to 3 weeks)
Cardiovascular complications
Cardiovascular complications are assessed by determining the number of patients presenting a severe cardiovascular complication within 7 days of inclusion
Time frame: within 7 days after inclusion
Neurological complications
Neurological complications are asssessed by determining the number of patients presenting stroke (ischemic stroke, subarachnoid hemorrhage or cerebral hematoma), confirmed by imaging (CT-scan or MRI) within 7 days of inclusion (systematic cerebral imaging is not required by the protocol but only in case of clinical suspicion of stroke or for neuroprognostication)
Time frame: within 7 days of inclusion
Cutaneous complications within 7 days of inclusion
Cutaneous complications are assessed by determining the number of patients presenting necrosis of the extremities within 7 days of inclusion
Time frame: within 7 days of inclusion
Digestive complications within 7 days after inclusion
Digestive complications are assessed by determining the number of patients presenting a clinical suspicion of digestive ischemia, confirmed by imaging (CT-scan), endoscopy or exploratory laparotomy, within 7 days of inclusion
Time frame: within 7 days of inclusion
Major bleeding within 7 days of inclusion
Major bleeding is assessed by determining the number of patients presenting one of the International Society on Thrombosis and Haemostasis (ISTH) criteria within 7 days of inclusion (fatal bleeding and/or symptomatic bleeding in a critical area or in an organ such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial or intramuscular with compartment syndrome and/or bleeding causing a fall in hemoglobin level of 20 g.L-1 or more or leading to transfusion of two or more units of red cells)
Time frame: within 7 days of inclusion
Global complications within 7 days of inclusion
Global complications are defined by the proportion of patients with at least one complication (cardiovascular, neurological, cutaneous, digestive or hemorrhagic) within 7 days of inclusion
Time frame: within 7 days of inclusion
Proportion of patients with a good neurofunctional prognosis at six months in the subgroup of patients with an initial shockable cardiac arrest rhythm and in the subgroup of patients with an initial non-shockable cardiac arrest rhythm
Proportion of patients with a good neurofunctional prognosis at six months in the subgroup of patients with an initial shockable cardiac arrest rhythm and in the subgroup of patients with an initial non-shockable cardiac arrest rhythm
Time frame: 6 months after inclusion
Proportion of patients with a good neurofunctional prognosis at six months in the subgroup of patients with confirmed chronic arterial hypertension and in the subgroup of patients without chronic arterial hypertension
Proportion of patients with a good neurofunctional prognosis at six months in the subgroup of patients with confirmed chronic arterial hypertension and in the subgroup of patients without chronic arterial hypertension. Chronic high blood pressure is defined as need for chronic treatment prior to cardiac arrest;
Time frame: 6 months after inclusion
Proportion of patients with good neurofunctional prognosis at six months in the three risks subgroups of patients identified by CAHP score (< 150, 150-200 and > 200).
Proportion of patients with good neurofunctional prognosis at six months in the three risks subgroups of patients identified by CAHP score (\< 150, 150-200 and \> 200). The CAHP score represents a simple tool for early stratification of patients admitted in ICU after OHCA, using seven variables (age, rhythm, time from collapse to basic life support, time from basic life support to ROSC, location of cardiac arrest, epinephrine dose and arterial pH)
Time frame: 6 months after inclusion
Plan to share: Yes — After publication of the main results, the anonymized data necessary for carrying out additional analyses may be made available upon request addressed to the coordinating investigator and the scientific committee
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Out-of-Hospital Cardiac Arrest →
Centre Hospitalier le Mans