Early Transcranial Doppler Goal Directed Therapy After Cardiac Arrest: a Pilot Study (GOODYEAR)

Centre Hospitalier le Mans

Status: Terminated

Conditions: Ischemic Encephalopathy; Ischemic Reperfusion Injury; Cerebral Lesion; Cardiac Arrest

Treatments: Other: MAP increased to optimize cerebral blood flow; Other: MAP between 65 and 85 mmHg

Study type: Interventional

Funder types: Other

Identifiers

NCT04000334

CHM-2019/S3/04

Details and patient eligibility

About

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).

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Cerebral hypoperfusion (group A)

Experimental group

Description:

Cerebral hypoperfusion will be defined by an abnormal TCD at inclusion (t0) when two of the three measured values are abnormal using the following thresholds: Vm \< 30 cm/s, Vd \< 20 cm/s, PI \> 1.4.

Treatment:

Other: MAP increased to optimize cerebral blood flow

Normal cerebral perfusion (group B)

Active Comparator group

Description:

Normal cerebral perfusion will be defined by a normal TCD at inclusion (t0) when two of the three measured values are normal using the following thresholds: Vm \> 30 cm/s, Vd \> 20 cm/s, PI \< 1.4.

Treatment:

Other: MAP between 65 and 85 mmHg