Status:
WITHDRAWN
The Effect of Sodium Oxybate on Sleep Architecture
Lead Sponsor:
Tufts Medical Center
Conditions:
Mechanically Ventilated ICU Patients
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
Sleep is disrupted in the critically ill and may lead to impaired neurocognitive function, decreased immune function, increased protein catabolism, and may compromise the ability to wean patients from...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00744393
Start Date
October 1 2008
End Date
December 1 2009
Last Update
February 23 2018
Active Locations (1)
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1
Tufts Medical Center
Boston, Massachusetts, United States, 02111