SleepPhase 4NCT00405847
A Pilot Study of Effect of Dexmedetomidine on Sleep and Inflammation in Critically Ill Patients
A Phase 4 study testing Dexmedetomidine in people with Sleep and Critical Illness, run by University of Arizona at 1 site in United States.
Trial summary
The purpose of this study is to assess the short-term effect of sympatholysis on sleep quality and inflammation in critically ill patients. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Sleep, Critical Illness
- What is being tested?
- Dexmedetomidine
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to May 2007
- Phase
- Phase 4
- 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring mechanical ventilation with a diagnosis of
- Acute Respiratory Distress Syndrome
- Cardiogenic Pulmonary Edema
- Pneumonia
- Chronic obstructive pulmonary disease
Who cannot join
- Patients who are considered too unstable to undergo this investigation by their primary physician
- Comatose patients, or patients with severe debilitating neurological disease
- Renal insufficiency (Sr. Creatinine > 2 mg/dL)
- Heart block (second or third degree heart block) or sinus bradycardia (heart rate < 60 beats per minute)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern Arizona VA Healthcare System
Tucson, Arizona, 85723
About this study
The purpose of this study is to assess the short-term effect of sympatholysis on sleep quality and inflammation in critically ill patients.
Read the detailed description
Over 1 million patients receive mechanical ventilation every year in the United States. In mechanically ventilated patients, despite sedative infusions, sleep is severely disrupted. Sleep disruption, in turn, can lead to activation of sympathetic nervous system and elevated inflammatory cytokines. Both sympathetic hyperactivity and elevated cytokines have been associated with delirium, which, in turn, is associated with increased mortality and higher healthcare costs. Currently, however, there is very little understanding of the inter-relationship between critical illness, sleep, and neuropsychological well-being. The purpose of this study is to collect preliminary data on the short-term effects of sedation with and without sympatholysis on sleep and inflammation in critically ill patients receiving mechanical ventilation. This pilot study will be accomplished by performing sleep studies and circulating cytokine measurements in critically ill patients randomized to receive two different sedation strategies: Dexmedetomidine versus Midazolam and Fentanyl. The ultimate goal of this program of research is to identify sedation practices that are least associated with adverse short- and long-term consequences, and thereby ultimately help improve sleep quality and quality of life in patients surviving critical illness.
- Conditions
- Sleep, Critical Illness
- Being tested
- Dexmedetomidine
- Keywords
- Sleep, Critical illness, Cytokine
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep disruption (Arousals, awakenings and sleep efficiency measured by polysomnography)
Circulating levels of Inflammatory cytokines (TNF-alpha, IL-1, IL-6, IL-10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2006 (estimated)
- Study startJul 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Investigators
- Sairam Parthasarathy, MD, Principal investigator, SAVAHCS and University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00405847
- Sponsor's protocol ID
- HSC #06-107
- Status last verified
- Oct 2016
- First submitted
- 29 Nov 2006
- Last updated
- 27 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Effect of Dexmedetomidine on Sleep and Inflammation in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT00405847
- Acronym / sponsor ID
- HSC #06-107
- Conditions
- Sleep, Critical Illness
- Keywords
- Sleep, Critical illness, Cytokine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- Jul 2006
- Study completion
- May 2007 (actual)
- First posted
- 30 Nov 2006 (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 assess the short-term effect of sympatholysis on sleep quality and inflammation in critically ill patients.
Detailed description
Over 1 million patients receive mechanical ventilation every year in the United States. In mechanically ventilated patients, despite sedative infusions, sleep is severely disrupted. Sleep disruption, in turn, can lead to activation of sympathetic nervous system and elevated inflammatory cytokines. Both sympathetic hyperactivity and elevated cytokines have been associated with delirium, which, in turn, is associated with increased mortality and higher healthcare costs. Currently, however, there is very little understanding of the inter-relationship between critical illness, sleep, and neuropsychological well-being. The purpose of this study is to collect preliminary data on the short-term effects of sedation with and without sympatholysis on sleep and inflammation in critically ill patients receiving mechanical ventilation. This pilot study will be accomplished by performing sleep studies and circulating cytokine measurements in critically ill patients randomized to receive two different sedation strategies: Dexmedetomidine versus Midazolam and Fentanyl. The ultimate goal of this program of research is to identify sedation practices that are least associated with adverse short- and long-term consequences, and thereby ultimately help improve sleep quality and quality of life in patients surviving critical illness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients requiring mechanical ventilation with a diagnosis of
Key exclusion criteria (5 listed)
- Patients who are considered too unstable to undergo this investigation by their primary physician
- Comatose patients, or patients with severe debilitating neurological disease
- Renal insufficiency (Sr. Creatinine > 2 mg/dL)
- Heart block (second or third degree heart block) or sinus bradycardia (heart rate < 60 beats per minute)
- Pregnancy
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 |
|---|---|---|
| Dexmedetomidine | Drug | – |
Primary outcome
Sleep disruption (Arousals, awakenings and sleep efficiency measured by polysomnography)
Circulating levels of Inflammatory cytokines (TNF-alpha, IL-1, IL-6, IL-10)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
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Healthy Adult Participants
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.
Sairam Parthasarathy, MD principal investigator
SAVAHCS and University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine in people with Sleep and Critical Illness, run by University of Arizona 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 27 Oct 2016. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sleep disruption (Arousals, awakenings and sleep efficiency measured by polysomnography). The study lists 2 primary outcomes in all. 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 27 Oct 2016.