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| Name | Class |
|---|---|
| Université de Nice Sophia Antipolis | OTHER |
| Medical University of Grenoble | OTHER |
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The goal of this study is to evaluate the effect of preventive intravenous infusion of half molar sodium lactate on the onset of hypertensive intracranial episodes in severe head trauma. The investigators hypothesize that preventive intravenous administration of sodium lactate will decrease the number of treatments required to decrease intracranial pressure during 48 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| half sodium lactate | Experimental | infusion of 0.5 ml/kg/day during 48 hours |
|
| isotonic sodium chloride | Active Comparator | infusion of 0.5 ml/kg during 48 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| half molar sodium lactate | Drug | intravenous infusion of 0.5 ml/kg during 48 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| the number of treatments required for intracranial hypertensive episodes during the first 48 hours following ICU admission | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| the neurological outcome at six months evaluated by the glasgow outcome scale | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carole Ichai, MD, PhD | Institut d'Anesthesiologie des Alpes Maritimes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut d'Anesthesiologie des Alpes maritimes | Nice | Nice | 06000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18807008 | Result | Ichai C, Armando G, Orban JC, Berthier F, Rami L, Samat-Long C, Grimaud D, Leverve X. Sodium lactate versus mannitol in the treatment of intracranial hypertensive episodes in severe traumatic brain-injured patients. Intensive Care Med. 2009 Mar;35(3):471-9. doi: 10.1007/s00134-008-1283-5. Epub 2008 Sep 20. |
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| ID | Term |
|---|---|
| D006259 | Craniocerebral Trauma |
| D019586 | Intracranial Hypertension |
| ID | Term |
|---|---|
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D019354 | Sodium Lactate |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D007773 | Lactates |
| D006880 | Hydroxy Acids |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| isotonic sodium chloride | Drug | intravenous infusion of 0.5 ml/kg during 48 hours |
|
|
| D002493 |
| Central Nervous System Diseases |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |