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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.
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Cerebral oxygenation modifications induced by increasing MAP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas Chudeau, MD | Centre Hospitalier Le Mans, Intensive Care Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Le Mans | Le Mans | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40677967 | Derived | 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. |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D002545 | Brain Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
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|
| MAP between 65 and 85 mmHg | Other | MAP will be maintained between 65-85 mmHg, using a norepinephrine infusion as needed. |
|
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 |
| 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 |
| Undesirable events induced by increasing MAP | Number of neurologic events defined by intracranial hematoma or brain death | At the 72nd hour after inclusion |
| Plasmatic concentrations of Neuron Specific Enolase | Neuron Specific Enolase (NSE) plasmatic concentrations at H+72h after cardiac arrest | At the 72nd hour after inclusion |
| 28 day survival | Proportion of patients alive 28 days after inclusion | 28 days after inclusion |
| 90 days survival | Proportion of patients alive 90 days after inclusion | 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.
| 90 days after inclusion |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |