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

NCT04000334 | Terminated

• 1 other identifier: CHM-2019/S3/04
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

cardiac arrest; cerebral blood flow; cerebral autoregulation; transcranial doppler

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Cerebral blood flow modifications induced by increasing MAP

  At the 6th, 12th, 24th, 48th and 72nd hour after inclusion

• Cerebral oxygenation modifications induced by increasing MAP

  At the 6th, 12th, 24th, 48th and 72nd hour after inclusion

• Undesirable events induced by increasing MAP

  At te 24th hour after inclusion

• Undesirable events induced by increasing MAP

  At the 72nd hour after inclusion

• Plasmatic concentrations of Neuron Specific Enolase

  At the 72nd hour after inclusion

Study Arms (2)

Cerebral hypoperfusion (group A)

EXPERIMENTAL

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.

Other: MAP increased to optimize cerebral blood flow

Normal cerebral perfusion (group B)

ACTIVE COMPARATOR

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.

Other: MAP between 65 and 85 mmHg

Interventions

MAP increased to optimize cerebral blood flow 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.

Cerebral hypoperfusion (group A)

MAP between 65 and 85 mmHg OTHER

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

Normal cerebral perfusion (group B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Transcranial doppler unavailable
• Cardiac arrythmia
• 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
• 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)
• 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

Sponsors & Collaborators

• Centre Hospitalier le Mans: lead

Study Sites (1)

Centre Hospitalier Le Mans

Le Mans, France

Location

Related Publications (1)

• 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.

  PMID: 40677967 DERIVED

MeSH Terms

Conditions

Heart Arrest; Brain Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Nicolas Chudeau, MD

  Centre Hospitalier Le Mans, Intensive Care Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2019
• First Posted: June 27, 2019
• Study Start: July 29, 2020
• Primary Completion: July 8, 2023
• Study Completion: July 8, 2023
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)