The Effect of Sodium Oxybate on Sleep Architecture

• Status: Withdrawn
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tufts Medical Center
• Treatments: Sodium Oxybate

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