Mean Arterial Pressure After Out-of-hospital Cardiac Arrest
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier le Mans
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 ;
Trial design
Design model
Parallel
Treatments tested in this trial
Maintain MAP ≥ 90 mmHg
Procedure/SurgeryMaintain MAP ≥ 90 mmHg for the 24 hours following inclusion by perfusion of norepinephrine
Maintain MAP ≥ 65 mmHg
Procedure/SurgeryMaintain MAP ≥ 65 mmHg for 24 hours after randomization through the perfusion of norepinephrine
Treatment groups
1,380 Participants
are divided into 2 treatment groupsGroup A: high MAP thresholdExperimental treatment 1 intervention
Group B: standard MAP thresholdActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 inclusionSecondary outcomes
1
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 inclusion2
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)3
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 inclusion4
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 inclusionOther outcomes
1
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 inclusion2
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 inclusion3
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 inclusion4
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 inclusionSponsors and contacts
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Source ClinicalTrials.gov