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

NCT ID: NCT04000334

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-29
• Study Completion Date: 2023-07-08

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).

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cerebral hypoperfusion (group A)

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.

Group Type: EXPERIMENTAL

MAP increased to optimize cerebral blood flow

Intervention Type: OTHER

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.

Normal cerebral perfusion (group B)

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.

Group Type: ACTIVE_COMPARATOR

MAP between 65 and 85 mmHg

Intervention Type: OTHER

MAP will be maintained between 65-85 mmHg, using a norepinephrine infusion as needed.

Interventions

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.

Intervention Type: OTHER

MAP between 65 and 85 mmHg

MAP will be maintained between 65-85 mmHg, using a norepinephrine infusion as needed.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier le Mans

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas Chudeau, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Le Mans, Intensive Care Unit

Locations

Centre Hospitalier Le Mans

Le Mans, , France

Countries

France

References

Meunier J, Engrand N, Saulnier P, Deye N, Landais M, Cariou A, Guitton C, Chudeau N. Transcranial Doppler goal-directed therapy after cardiac arrest (GOODYEAR): a feasibility study. Resusc Plus. 2025 Jun 14;25:101001. doi: 10.1016/j.resplu.2025.101001. eCollection 2025 Sep.

Reference Type: DERIVED

PMID: 40677967 (View on PubMed)

Other Identifiers

CHM-2019/S3/04

Identifier Type: -

Identifier Source: org_study_id