The Effect of Sodium Oxybate on Sleep Architecture

NCT00744393 | Withdrawn Phase 2

• 1 other identifier: NEMC-8479
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanically Ventilated ICU Patients

Keywords

sleep; critically ill; mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• To gain a better understanding of the effect of sodium oxybate on the following components of sleep architecture: % time in sleep stage and arousals and awakenings

  72 hours

Secondary Outcomes (1)

• To observe any short-term adverse effects of sodium oxybate in mechanically ventilated ICU patients

  72 hours

Study Arms (2)

A

ACTIVE COMPARATOR

Active drug

Drug: sodium oxybate

P

PLACEBO COMPARATOR

Placebo drug

Drug: placebo

Interventions

sodium oxybate DRUG

The dose of sodium oxybate will be 4.5g every 4 hours x 2 doses. The first dose of study medication will be given at 10pm followed by the next dose four hours later and crossed over the next day

Also known as: XYREM

A

placebo DRUG

The dose of placebo sodium oxybate will be 4.5g every 4 hours x 2 doses. The first dose of study medication will be given at 10pm followed by the next dose four hours later and then crossed over the next day

Also known as: Xyrem

P

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Critical Illness

Interventions

Sodium Oxybate

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxybutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids

Study Officials

• Carolyn D'Ambrosio, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2008
• First Posted: September 1, 2008
• Study Start: October 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 23, 2018

Record last verified: 2018-02

Locations

US (1)