Cardiac ArrestGOODYEARNCT04000334
Early Transcranial Doppler Goal Directed Therapy After Cardiac Arrest: a Pilot Study
A study testing MAP increased to optimize cerebral blood flow and MAP between 65 and 85 mmHg in people with Cardiac Arrest and Cerebral Lesion, run by Centre Hospitalier le Mans at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Cerebral Lesion, Ischemic Encephalopathy
- What is being tested?
- MAP increased to optimize cerebral blood flow and MAP between 65 and 85 mmHg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jul 2020to 8 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Being tested
- MAP increased to optimize cerebral blood flow, MAP between 65 and 85 mmHg
- Keywords
- cardiac arrest, cerebral blood flow, cerebral autoregulation, transcranial doppler
- Medical subject headings
- Heart Arrest, Brain Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAP increased to optimize cerebral blood flowOther
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 mmHgOther
MAP will be maintained between 65-85 mmHg, using a norepinephrine infusion as needed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: MAP between 65 and 85 mmHg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: In the first hour after inclusion
Secondary outcomes (8)
Cerebral blood flow modifications induced by increasing MAP
Transcranial doppler data modifications induced by increasing MAP to 90-100 mmHg and 100-110 mmHg.
Measured: At the 6th, 12th, 24th, 48th and 72nd hour after inclusion
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.
Measured: At the 6th, 12th, 24th, 48th and 72nd hour after inclusion
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
Measured: At te 24th hour after inclusion
Undesirable events induced by increasing MAP
Number of neurologic events defined by intracranial hematoma or brain death
Measured: At the 72nd hour after inclusion
Plasmatic concentrations of Neuron Specific Enolase
Neuron Specific Enolase (NSE) plasmatic concentrations at H+72h after cardiac arrest
Measured: At the 72nd hour after inclusion
28 day survival
Proportion of patients alive 28 days after inclusion
Measured: 28 days after inclusion
90 days survival
Proportion of patients alive 90 days after inclusion
Measured: 90 days after inclusion
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.
Measured: 90 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start29 Jul 2020
- Primary completion8 Jul 2023
- Study completion8 Jul 2023
Why it stopped: Due to the difficulty of recruiting patients and the fact that, despite the team's best efforts, the inclusion period initially planned had largely passed, it did not appear ethical to continue the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier le Mans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Chudeau, MD, Principal investigator, Centre Hospitalier Le Mans, Intensive Care Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04000334
- Sponsor's protocol ID
- CHM-2019/S3/04
- Acronym
- GOODYEAR
- Status last verified
- Apr 2025
- First submitted
- 22 Jun 2019
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40677967
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Transcranial Doppler Goal Directed Therapy After Cardiac Arrest: a Pilot Study
- ClinicalTrials.gov ID
- NCT04000334
- Acronym / sponsor ID
- GOODYEAR / CHM-2019/S3/04
- Keywords
- cardiac arrest, cerebral blood flow, cerebral autoregulation, transcranial doppler
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the difficulty of recruiting patients and the fact that, despite the team's best efforts, the inclusion period initially planned had largely passed, it did not appear ethical to continue the study.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier le MansUniversity, hospital or other
- Study start
- 29 Jul 2020 (actual)
- Primary completion
- 8 Jul 2023 (actual)
- Study completion
- 8 Jul 2023 (actual)
- First posted
- 27 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cerebral hypoperfusion (group A) | Experimental | Other: MAP increased to optimize cerebral blood flowCerebral 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. |
| Normal cerebral perfusion (group B) | Active comparator | Other: MAP between 65 and 85 mmHgNormal 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAP increased to optimize cerebral blood flowMAP 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. | Other | Cerebral hypoperfusion (group A) |
| MAP between 65 and 85 mmHgMAP will be maintained between 65-85 mmHg, using a norepinephrine infusion as needed. | Other | Normal cerebral perfusion (group B) |
Primary outcome
Proportion of patients in whom the transcranial doppler goal directed therapy will result in a modification of MAP targets
Time frame: In the first hour after inclusion
Proportion of patients in whom transcranial doppler goal directed therapy will result in a modification of MAP targets.
8 secondary outcomes
Cerebral blood flow modifications induced by increasing MAP
Time frame: At the 6th, 12th, 24th, 48th and 72nd hour after inclusion
Cerebral oxygenation modifications induced by increasing MAP
Time frame: At the 6th, 12th, 24th, 48th and 72nd hour after inclusion
Undesirable events induced by increasing MAP
Time frame: At te 24th hour after inclusion
Undesirable events induced by increasing MAP
Time frame: At the 72nd hour after inclusion
Plasmatic concentrations of Neuron Specific Enolase
Time frame: At the 72nd hour after inclusion
28 day survival
Time frame: 28 days after inclusion
90 days survival
Time frame: 90 days after inclusion
Measure of the degree of disability in the activities of daily living of the included patients
Time frame: 90 days after inclusion
Results and safety
The study was stopped early (reason given: Due to the difficulty of recruiting patients and the fact that, despite the team's best efforts, the inclusion period initially planned had largely passed, it did not appear ethical to continue the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Derived from this study: PubMed 40677967Meunier 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Chudeau, MD principal investigator
Centre Hospitalier Le Mans, Intensive Care Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAP increased to optimize cerebral blood flow and MAP between 65 and 85 mmHg in people with Cardiac Arrest and Cerebral Lesion, run by Centre Hospitalier le Mans at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to the difficulty of recruiting patients and the fact that, despite the team's best efforts, the inclusion period initially planned had largely passed, it did not appear ethical to continue the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients in whom the transcranial doppler goal directed therapy will result in a modification of MAP targets (time frame: In the first hour after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04000334, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.