Cardiac Arrest Clinical Trial
— GOODYEAROfficial title:
Early Transcranial Doppler Goal Directed Therapy After Cardiac Arrest: a Pilot Study
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).
Status | Recruiting |
Enrollment | 40 |
Est. completion date | September 2022 |
Est. primary completion date | September 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Le Mans | Le Mans |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier le Mans |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients in whom the transcranial doppler goal directed therapy will result in a modification of MAP targets | Proportion of patients in whom transcranial doppler goal directed therapy will result in a modification of MAP targets. | In the first hour after inclusion | |
Secondary | Cerebral blood flow modifications induced by increasing MAP | Transcranial doppler data modifications induced by increasing MAP to 90-100 mmHg and 100-110 mmHg. | At the 6th, 12th, 24th, 48th and 72nd hour after inclusion | |
Secondary | Cerebral oxygenation modifications induced by increasing MAP | Bulb jugular venous oxygen saturation modifications induced by increasing MAP at 90-100 mmHg and 100-110 mmHg. | At the 6th, 12th, 24th, 48th and 72nd hour after inclusion | |
Secondary | Undesirable events induced by increasing MAP | Number of cardiovascular events defined by new onset of severe cardiac arrythmias, acute coronary syndromes, cardiogenic pulmonary edema, cardiogenic shock or cardiac arrest | At te 24th hour after inclusion | |
Secondary | Undesirable events induced by increasing MAP | Number of neurologic events defined by intracranial hematoma or brain death | At the 72nd hour after inclusion | |
Secondary | Plasmatic concentrations of Neuron Specific Enolase | Neuron Specific Enolase (NSE) plasmatic concentrations at H+72h after cardiac arrest | At the 72nd hour after inclusion | |
Secondary | 28 day survival | Proportion of patients alive 28 days after inclusion | 28 days after inclusion | |
Secondary | 90 days survival | Proportion of patients alive 90 days after inclusion | 90 days after inclusion | |
Secondary | Measure of the degree of disability in the activities of daily living of the included patients | Modified Rankin scale (MRS) 90 days after inclusion. The scale runs from 0-6, running from perfect health without symptoms to death.
0 - No symptoms. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. - Moderate disability. Requires some help, but able to walk unassisted. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. - Dead. |
90 days after inclusion |
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