The Effect of Sodium Oxybate on Sleep Architecture

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Mechanically Ventilated ICU Patients

In brief

The purpose of this study is to determine what effect sodium oxybate has on the functions of sleep in mechanically ventilated, critically ill patients hospitalized in an intensive care unit.

Key facts

Study ID

NCT00744393

Run by

Tufts Medical Center

People needed

0

Starts

2008-10-01

Expected to finish

2009-12-01

Last updated by the study team

2018-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Tufts Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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