DeliriumPhase 4NCT02548923
Dexmedetomidine Versus Propofol for Prolonged Sedation in Critically Ill Trauma and Surgical Patients
A Phase 4 study testing Dexmedetomidine in people with Delirium, run by University of Tennessee Graduate School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to assess the efficacy of dexmedetomidine versus propofol for prolonged sedation in trauma and surgical patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Apr 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients were included in the study if they were 18 years of age or older,
- mechanically ventilated,
- placed on the institutional sedation protocol,
- expected to require sedation lasting 24 hours after randomization, and
- admitted to the TSICU and followed by the Trauma/Surgical Service.
Who cannot join
- Patients were excluded for any of the following:
- 72 hours or greater since sedation protocol initiation,
- treatment per the institutional traumatic brain injury (TBI) protocol,
- concomitant continuous infusion of a neuromuscular blocking agent,
- heart rate less than 50 beats per minute,
- mean arterial pressure less than 55 mmHg despite fluid resuscitation and vasopressors, and
- use of other alpha-2 agonists within 24 hours of randomization.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee Medical Center
Knoxville, Tennessee, 37922
About this study
The purpose of this study is to assess the efficacy of dexmedetomidine versus propofol for prolonged sedation in trauma and surgical patients.
Read the detailed description
Design: Open-label, single-center prospective study. Setting: Trauma/Surgical Intensive Care Unit (TSICU) at a Level I academic trauma center.
Patients: Patients 18 years of age or older requiring mechanical ventilation and admitted to the TSICU Interventions: Patients were randomly assigned based on unit bed location to receive dexmedetomidine or propofol for sedation.
- Conditions
- Delirium
- Being tested
- Dexmedetomidine
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Propofol
comparison to propofol
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine group | Active comparator | Patients who received dexmedetomidine for sedation Receives: Drug: Dexmedetomidine |
| propofol group | No intervention | Patients who received propofol for sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Mechanical Ventilation
An average of 10 days
Measured: ICU stay
Secondary outcomes (6)
Mortality
An average of 21 days
Measured: Hospital length of stay
proportion of time in target sedation
AN average of 10 days
Measured: ICU length of stay
incidence of delirium
An average of 10 days
Measured: ICU length of stay
hypotension
Measured: ICU length of stay
bradycardia
AN Average of 10 days
Measured: ICU length of stay
ICU and hospital length of stay
An average of 21 days
Measured: hospital length of stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study startNov 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee Graduate School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Daley, University of Tennessee Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548923
- Sponsor's protocol ID
- UTMCKTRAUMA1
- Status last verified
- Sep 2015
- First submitted
- 14 Aug 2015
- Last updated
- 14 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Versus Propofol for Prolonged Sedation in Critically Ill Trauma and Surgical Patients
- ClinicalTrials.gov ID
- NCT02548923
- Acronym / sponsor ID
- UTMCKTRAUMA1
- Conditions
- Delirium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of Tennessee Graduate School of MedicineUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 14 Sep 2015 (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 efficacy of dexmedetomidine versus propofol for prolonged sedation in trauma and surgical patients.
Detailed description
Design: Open-label, single-center prospective study. Setting: Trauma/Surgical Intensive Care Unit (TSICU) at a Level I academic trauma center.
Patients: Patients 18 years of age or older requiring mechanical ventilation and admitted to the TSICU Interventions: Patients were randomly assigned based on unit bed location to receive dexmedetomidine or propofol for sedation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine group | Active comparator | Drug: DexmedetomidinePatients who received dexmedetomidine for sedation |
| propofol group | No intervention | –Patients who received propofol for sedation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients were included in the study if they were 18 years of age or older,
- mechanically ventilated,
- placed on the institutional sedation protocol,
- expected to require sedation lasting 24 hours after randomization, and
- admitted to the TSICU and followed by the Trauma/Surgical Service.
Key exclusion criteria (7 listed)
- 72 hours or greater since sedation protocol initiation,
- treatment per the institutional traumatic brain injury (TBI) protocol,
- concomitant continuous infusion of a neuromuscular blocking agent,
- heart rate less than 50 beats per minute,
- mean arterial pressure less than 55 mmHg despite fluid resuscitation and vasopressors, and
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 |
|---|---|---|
| DexmedetomidineAlso: Propofolcomparison to propofol | Drug | dexmedetomidine group |
Primary outcome
Duration of Mechanical Ventilation
Time frame: ICU stay
An average of 10 days
6 secondary outcomes
Mortality
Time frame: Hospital length of stay
proportion of time in target sedation
Time frame: ICU length of stay
incidence of delirium
Time frame: ICU length of stay
hypotension
Time frame: ICU length of stay
bradycardia
Time frame: ICU length of stay
ICU and hospital length of stay
Time frame: hospital length of stay
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 14 Sep 2015.
Related trials for Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Delirium, run by University of Tennessee Graduate School of Medicine 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 7 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 14 Sep 2015. 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?
Duration of Mechanical Ventilation (time frame: ICU stay). 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 14 Sep 2015.