Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT04000334
Eligibility Criteria:
Inclusion Criteria:
* Patients admitted in the Intensive Care Unit (ICU) under mechanical ventilation with a Glasgow Coma Scale ≤ 8/15 after in- or out-of-hospital cardiac arrest
* Mean arterial pressure between 65 and 85 mmHg with or without vasopressor support
Exclusion Criteria:
* Age \< 18 years old
* No flow (time between cardiac arrest and the beginning of cardiac massage) \> 15 minutes or unknown
* Low flow ((time between cardiac arrest and ROSC: return of spontaneous circulation)\> 60 minutes
* Time between ROSC and inclusion \> 12 hours
* Transcranial doppler unavailable
* Cardiac arrythmia
* Patient under extracorporeal life support before inclusion or at risk of being referred for assistance due to cardiogenic shock with high dose of vasopressors before inclusion (MAP \< 65 mmHg with norepinephrine or epinephrine \> 1 µg/kg/min or dobutamine \> 10 µg/kg/min)
* Severe cardiac dysfunction defined by left ventricular ejection fraction \< 20% or aortic Velocity Time Integral (VTI: measured with trans-thoracic echocardiography) \< 14 cm with dobutamine \> 10µg/kg/min
* Patient under Extracorporeal Membrane Oxygenation (ECMO) for Acute Respiratory Distress Syndrome (ARDS) before inclusion
* Cardiac arrest secondary to brain injury such as stroke, subarachnoid hemorrhage or traumatic brain injury
* Hemorrhagic shock
* Any acute pathology that requires strict blood pressure control (aortic dissection, stroke, cardiogenic pulmonary edema with high blood pressure)
* Decision of withdrawing or withholding life sustaining treatment before inclusion or considered during the first 12 hours of ICU management
* Patient with a modified Rankin scale (MRS) 4 or 5 prior to resuscitation
* Pregnancy or lactation
* Patients already enrolled in another clinical study on cardiac arrest
* Patients with judicial protection
* No social security coverage
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04000334
Study Brief:
Protocol Section:
NCT04000334