Mechanically Ventilated ICU PatientsPhase 2NCT00744393
The Effect of Sodium Oxybate on Sleep Architecture
A Phase 2 study testing sodium oxybate in people with Mechanically Ventilated ICU Patients, run by Tufts Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanically Ventilated ICU Patients
- What is being tested?
- sodium oxybate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Dec 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Sodium Oxybate on Sleep Architecture in Critically Ill Patients: A Double-Blind, Crossover Pilot Study
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.
Read the 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 mechanical ventilation. Critically ill patients may appear to sleep throughout most of their stay, but their quality of sleep is different from that of a normal healthy subject.Critically ill patients spend more time in the wakefulness stages of sleep (Stage 1 and 2) at the expense of the restorative stages (Stage 3 and 4) and REM sleep. These patients also experience an increased number of arousals and awakenings. Various factors are thought to be the cause of abnormal sleep architecture: ICU environment, pain, illness severity, psychosocial stress, medications, and mechanical ventilation.
Sodium oxybate (Xyrem®) is the sodium salt of the central nervous system depressant γ-hydroxybutyric acid (GHB) and is currently approved for use in narcoleptic patients to improve cataplexy and excessive daytime sleepiness.
Studies evaluating the use of sodium oxybate in narcoleptic patients suggest that sodium oxybate is effective at increasing slow-wave sleep, sleep efficiency, sleep latency, and REM-sleep efficiency, while also decreasing REM-sleep latency, stage 1 NREM sleep and sleep fragmentation.3, 16-19 Currently there is a lack of data evaluating the effects of sodium oxybate on sleep in critically ill patients. Obtaining evidence that sodium oxybate improves sleep architecture in the critically ill, may provide the foundation to complete future studies evaluating the effect of sodium oxybate on clinical outcomes such as duration of mechanical ventilation and length of ICU stay. Based on sodium oxybate's ability to improve sleep architecture in narcoleptic patients along with the fact that critically ill patients have similar disrupted sleep architecture, it's postulated that sodium oxybate may improve the sleep architecture in critically ill patients.
- Conditions
- Mechanically Ventilated ICU Patients
- Being tested
- sodium oxybate, placebo
- Keywords
- sleep, critically ill, mechanical ventilation
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium oxybateDrug
Also called XYREM
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
placeboDrug
Also called Xyrem
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
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Active drug Receives: Drug: sodium oxybate |
| P | Placebo comparator | Placebo drug Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 72 hours
Secondary outcomes (1)
To observe any short-term adverse effects of sodium oxybate in mechanically ventilated ICU patients
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Why it stopped: Sponsor pulled funding secondary to economy issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanically Ventilated ICU PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carolyn D'Ambrosio, MD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00744393
- Sponsor's protocol ID
- NEMC-8479
- Status last verified
- Feb 2018
- First submitted
- 29 Aug 2008
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sodium Oxybate on Sleep Architecture in Critically Ill Patients: A Double-Blind, Crossover Pilot Study
- ClinicalTrials.gov ID
- NCT00744393
- Acronym / sponsor ID
- NEMC-8479
- Conditions
- Mechanically Ventilated ICU Patients
- Keywords
- sleep, critically ill, mechanical ventilation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor pulled funding secondary to economy issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 1 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 mechanical ventilation. Critically ill patients may appear to sleep throughout most of their stay, but their quality of sleep is different from that of a normal healthy subject.Critically ill patients spend more time in the wakefulness stages of sleep (Stage 1 and 2) at the expense of the restorative stages (Stage 3 and 4) and REM sleep. These patients also experience an increased number of arousals and awakenings. Various factors are thought to be the cause of abnormal sleep architecture: ICU environment, pain, illness severity, psychosocial stress, medications, and mechanical ventilation.
Sodium oxybate (Xyrem®) is the sodium salt of the central nervous system depressant γ-hydroxybutyric acid (GHB) and is currently approved for use in narcoleptic patients to improve cataplexy and excessive daytime sleepiness.
Studies evaluating the use of sodium oxybate in narcoleptic patients suggest that sodium oxybate is effective at increasing slow-wave sleep, sleep efficiency, sleep latency, and REM-sleep efficiency, while also decreasing REM-sleep latency, stage 1 NREM sleep and sleep fragmentation.3, 16-19 Currently there is a lack of data evaluating the effects of sodium oxybate on sleep in critically ill patients. Obtaining evidence that sodium oxybate improves sleep architecture in the critically ill, may provide the foundation to complete future studies evaluating the effect of sodium oxybate on clinical outcomes such as duration of mechanical ventilation and length of ICU stay. Based on sodium oxybate's ability to improve sleep architecture in narcoleptic patients along with the fact that critically ill patients have similar disrupted sleep architecture, it's postulated that sodium oxybate may improve the sleep architecture in critically ill patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: sodium oxybateActive drug |
| P | Placebo comparator | Drug: placeboPlacebo drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sodium oxybateAlso: XYREMThe 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 | Drug | A |
| placeboAlso: XyremThe 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 | Drug | P |
Primary outcome
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
Time frame: 72 hours
1 secondary outcome
To observe any short-term adverse effects of sodium oxybate in mechanically ventilated ICU patients
Time frame: 72 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
Related trials for Mechanically Ventilated ICU Patients
Recruiting
STimulation to Activate RespIration
ARDS (Moderate or Severe), AHRF
Not yet recruitingPhase 4
the Effect of Doxapram on Diaphragmatic Excursion(DE) During Weaning From Mechanical Ventilation.
Mechanically Ventilated ICU Patients, Diaphragm Excursion
Recruiting
Effectiveness of Inspiratory Muscle Training in Weaning ICU Patients
Mechanically Ventilated ICU Patients
RecruitingPhase 3
Effect of Remimazolam Sedation on Outcomes of Mechanically Ventilated Patients in the ICU
Remimazolam Besylate, Mechanically Ventilated ICU Patients
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolyn D'Ambrosio, MD principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sodium oxybate in people with Mechanically Ventilated ICU Patients, run by Tufts Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2018; AzTrials last refreshed its copy on 6 Nov 2026.