Early Transcranial Doppler Goal Directed Therapy After Cardiac Arrest: a Pilot Study
Overview
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Centre Hospitalier le Mans
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Proportion of patients in whom the transcranial doppler goal directed therapy will result in a modification of MAP targets
Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Proportion of patients in whom the transcranial doppler goal directed therapy will result in a modification of MAP targets
Time Frame: In the first hour after inclusion
Proportion of patients in whom transcranial doppler goal directed therapy will result in a modification of MAP targets.
Secondary Outcomes
- Cerebral oxygenation modifications induced by increasing MAP(At the 6th, 12th, 24th, 48th and 72nd hour after inclusion)
- 28 day survival(28 days after inclusion)
- Cerebral blood flow modifications induced by increasing MAP(At the 6th, 12th, 24th, 48th and 72nd hour after inclusion)
- Measure of the degree of disability in the activities of daily living of the included patients(90 days after inclusion)
- Undesirable events induced by increasing MAP(At the 72nd hour after inclusion)
- Plasmatic concentrations of Neuron Specific Enolase(At the 72nd hour after inclusion)
- 90 days survival(90 days after inclusion)