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The Main objective of the trial is to assess sleep quality with Gamma-OH® in patients difficult to wean from mechanical ventilation in the ICU.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One arm with Gamma-OH® treatment | Experimental | Gamma-OH® will be administered intravenously at a dose of 20 mg/kg/h for 6 hours between 10 p.m. to 4 a.m. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gamma Hydroxybutyrate | Drug | Gamma-OH® will be administered intravenously at a dose of 20 mg/kg/h for 6 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients having poor sleep with Gamma-OH | Primary end point will be analyzed from sleep recordings performed during a single night with Gamma-OH®. | Hour24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Poitiers | Poitiers | Poitiers | 86000 | France |
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| ID | Term |
|---|---|
| D012978 | Sodium Oxybate |
| ID | Term |
|---|---|
| D006885 | Hydroxybutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| D009930 |
| Organic Chemicals |
| D006880 | Hydroxy Acids |