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

Last updated: April 29, 2025
Sponsor: Centre Hospitalier le Mans
Overall Status: Terminated

Phase

N/A

Condition

Organ Transplant

Circulation Disorders

Stroke

Treatment

MAP increased to optimize cerebral blood flow

MAP between 65 and 85 mmHg

Clinical Study ID

NCT04000334
CHM-2019/S3/04
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Patients admitted in the Intensive Care Unit (ICU) under mechanical ventilation witha 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

Exclusion Criteria:

  • Age < 18 years old

  • No flow (time between cardiac arrest and the beginning of cardiac massage) > 15minutes 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 beingreferred for assistance due to cardiogenic shock with high dose of vasopressorsbefore inclusion (MAP < 65 mmHg with norepinephrine or epinephrine > 1 µg/kg/min ordobutamine > 10 µg/kg/min)

  • Severe cardiac dysfunction defined by left ventricular ejection fraction < 20% oraortic Velocity Time Integral (VTI: measured with trans-thoracic echocardiography) < 14 cm with dobutamine > 10µg/kg/min

  • Patient under Extracorporeal Membrane Oxygenation (ECMO) for Acute RespiratoryDistress Syndrome (ARDS) before inclusion

  • Cardiac arrest secondary to brain injury such as stroke, subarachnoid hemorrhage ortraumatic 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 orconsidered 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

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: MAP increased to optimize cerebral blood flow
Phase:
Study Start date:
July 29, 2020
Estimated Completion Date:
July 08, 2023

Connect with a study center

  • Centre Hospitalier Le Mans

    Le Mans,
    France

    Site Not Available

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