Clinical trial NCT04000334: Early Transcranial Doppler Goal Directed Therapy After Cardiac Arrest: a Pilot Study
Official title: Early Transcranial Doppler Goal Directed Therapy After Cardiac Arrest: a Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiac Arrest
Cerebral Lesion
Ischemic Encephalopathy
Ischemic Reperfusion Injury
Keywords: cardiac arrest
cerebral blood flow
cerebral autoregulation
transcranial doppler
Lead sponsor: Centre Hospitalier le Mans
Sponsor class: OTHER
First posted: 2019-06-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Proportion of patients in whom the transcranial doppler goal directed therapy will result in a modification of MAP targets
timeFrame: In the first hour after inclusion
Secondary outcomes:
measure: Cerebral blood flow modifications induced by increasing MAP
timeFrame: At the 6th, 12th, 24th, 48th and 72nd hour after inclusion
measure: Cerebral oxygenation modifications induced by increasing MAP
timeFrame: At the 6th, 12th, 24th, 48th and 72nd hour after inclusion
measure: Undesirable events induced by increasing MAP
timeFrame: At te 24th hour after inclusion
measure: Undesirable events induced by increasing MAP
timeFrame: At the 72nd hour after inclusion
measure: Plasmatic concentrations of Neuron Specific Enolase
timeFrame: At the 72nd hour after inclusion
measure: 28 day survival
timeFrame: 28 days after inclusion
measure: 90 days survival
timeFrame: 90 days after inclusion
measure: Measure of the degree of disability in the activities of daily living of the included patients
timeFrame: 90 days after inclusion
Other outcomes:
Locations:
city: Le Mans
country: France
facility: Centre Hospitalier Le Mans
Study officials:
affiliation: Centre Hospitalier Le Mans, Intensive Care Unit
name: Nicolas Chudeau, MD
role: PRINCIPAL_INVESTIGATOR
References: