Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 1:17 AM
NCT ID:
NCT00744393
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Mechanically ventilated ≥ 24º on an AC mode
* Placement of enteral or gastric tube (Note: these tubes will not be placed exclusively for the purposes of the study.)
* Tolerating enteral nutrition via either the stomach or small intestine (≥20mL/hr for ≥ 12 hours)
Exclusion Criteria:
* Anticipated duration of mechanical ventilation ≤72º (as per MICU team estimate)
* Riker SAS ≤ 2 (as determined by patient's nurse and/or study investigator)
* History of irreversible brain disease consistent with severe dementia based on MICU service admission note
* Admitted with a primary neurological condition (e.g. intracranial hemorrhage)
* History of seizure disorder or intracranial surgery
* History of myocardial infarction in prior 6 months
* Pregnancy (all women of child bearing potential will undergo a serum pregnancy test prior to study consent)
* Administration of a scheduled benzodiazepine as either a continuous drip or given by IVP
* Acute alcohol withdrawal
* AST/ALT \>2 times ULN, INR \>2 or T bilirubin \> 1.5
* Current or prior use of sodium oxybate in the -past 30 days.
* Hypernatremia with a serum sodium \>150
* Current use of the following hypnotics: barbiturates, melatonin, zolpidem, eszopiclone, or zaleplon
* Use of neuromuscular blocking agents
* Allergy to sodium oxybate
* Known succinic semialdehyde dehydrogenase deficiency
* History of periodic limb movement disorder.
* A prognosis considered to be hopeless (as per MICU team)
* Inability to obtain informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00744393
Study Brief:
Protocol Section:
NCT00744393