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

Cardiac Arrest Clinical Trial

— GOODYEAR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04000334
• Other study ID #: CHM-2019/S3/04
• Status: Recruiting
• Phase: N/A
• Start date: July 29, 2020
• Est. completion date: September 2022

Study information

• Verified date: March 2022
• Source: Centre Hospitalier le Mans
• Contact: Christelle Jadeau, PD
• Phone: 0 (33) 2 43 43 43 43
• Email: cjadeau[@]ch-lemans.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Cardiac Arrest
• Cerebral Lesion
• Heart Arrest
• Ischemia
• Ischemic Encephalopathy
• Ischemic Reperfusion Injury
• Reperfusion Injury

Intervention

Other:
• MAP increased to optimize cerebral blood flow
MAP will be increased to 90-100 mmHg with norepinephrine. If TCD is still abnormal with a MAP of 90-100 mmHg, MAP will be increased to 100-110 mmHg. At each step, all CBF determinants will be recorded as well as cardiac output and Veinous jugular oxygen saturation (SvjO2). When TCD is normalized with no complications, MAP will be maintained at 90-100 or 100-110 mmHg during 24 hours.
• MAP between 65 and 85 mmHg
MAP will be maintained between 65-85 mmHg, using a norepinephrine infusion as needed.

Locations

Country	Name	City	State
France	Centre Hospitalier Le Mans	Le Mans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier le Mans

Country where clinical trial is conducted

France, 

Outcome

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