Early Transcranial Doppler Goal Directed Therapy After Cardiac Arrest: a Pilot Study (NCT04000334) | Clinical Trial Compass
TerminatedNot Applicable
Early Transcranial Doppler Goal Directed Therapy After Cardiac Arrest: a Pilot Study
Stopped: Due to the difficulty of recruiting patients and the fact that, despite the team's best efforts, the inclusion period initially planned had largely passed, it did not appear ethical to continue the study.
France20 participantsStarted 2020-07-29
Plain-language summary
Hypoxic-ischaemic brain injury (HIBI) is the main cause of death in patients who are comatose after resuscitation from cardiac arrest. Current guidelines recommend to target a mean arterial pressure (MAP) above 65 mmHg to achieve an adequate organ perfusion. Moreover, after cardiac arrest, cerebral autoregulation is dysregulated and cerebral blood flow (CBF) depends on the MAP. A higher blood pressure target could improve cerebral perfusion and HIBI. Transcranial Doppler (TCD) is a non-invasive method to study CBF and its variations induced by MAP.
The aim of this study is to test the feasibility of an early-goal directed hemodynamic management with TCD during the first 12 hours after return of spontaneous circulation (ROSC).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
* Decis…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients in whom the transcranial doppler goal directed therapy will result in a modification of MAP targets