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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-004979-21 | EudraCT Number |
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evolution of patient's care allows no more recruitment
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Will an increase of the dose of mannitol improve the effects on neuromonitoring in patients suffering intracranial hypertension following traumatic brain injury?
traumatic brain injury intracranial hypertension 0,4 g/ kg vs 0,8 g/ kg (randomized) on 20 minutes monitoring: ICP, transcranial doppler, brain pO2, MAP, HR, diuresis, biology duration: 2 hours
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mannitol high dose | Active Comparator | mannitol 20% 0,8 g/ kg on minutes |
|
| mannitol low dose | Active Comparator | mannitol 20% 0,4 g/ kg on minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| variation of mannitol dose | Drug | in case of intracranial hypertension up to 20 mmHg lasting more than 10 minutes and without nociceptive stimulation or systemic instability: injection of either 0.4 g/ kg or 0.8 g/ kg of mannitol 20% (randomized) on 20 minutes, with monitoring of neurologic, systemic and biologic datas during 120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| intracranial pressure | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| transcranial doppler | 2 h | |
| brain PO2 | 2h | |
| MAP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gilles Francony, MD | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitary Hospital | Grenoble | 38043 | France |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D019586 | Intracranial Hypertension |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| 2h |
| Heart Rate | 2h |
| biology (blood gases, natremia, hematocrit) | 2h |
| diuresis | 2h |
| fluid requirement | 2h |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |