Mechanical VentilationPhase 4NCT01059929
Dexmedetomidine Versus Propofol in the Medical Intensive Care Unit (MICU)
A Phase 4 study testing Dexmedetomidine, Propofol and Fentanyl in people with Mechanical Ventilation and Critical Illness, run by University of Chicago at 1 site in United States.
Trial summary
This is a randomized controlled trial to compare propofol to dexmedetomidine for prolonged sedation (> 24 hours) in critically ill patients who require mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Critical Illness
- What is being tested?
- Dexmedetomidine, Propofol and Fentanyl
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Sep 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- >18 years old
- mechanically ventilated through endotracheal tube
- anticipated need for ventilation > 48 hours
- requiring sedative/analgesic medication
Who cannot join
- on mechanical ventilator > 96 hours
- primary neurologic disease
- post cardiac arrest
- do not speak English (assessment only English language validated)
- pregnancy or lactation
- active myocardial ischemia
Show all 9Show fewer
- second or third degree heart block
- pancreatitis
- elevated serum triglycerides (> 400 mg/dL)
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
Official title: A Double-blinded Randomized Controlled Trial of Dexmedetomidine Versus Propofol for Sedation in Mechanically Ventilated Medical Intensive Care Unit Patients.
This is a randomized controlled trial to compare propofol to dexmedetomidine for prolonged sedation (> 24 hours) in critically ill patients who require mechanical ventilation.
Read the detailed description
Mechanically ventilated critically ill patients are routinely given sedative and analgesic medications to relieve pain and anxiety associated with intubation, mechanical ventilation, and critical care in general. While integral in minimizing discomfort, these medications may increase mechanical ventilation time, the duration of intensive care unit (ICU) stay, ICU complications (e.g. delirium, ventilator associated pneumonia, venous thromboembolism), the morbidity associated with critical illness, and patient mortality. This study compares two sedative medications that have been used in patients who require a mechanical ventilator. Enrolled patients will be randomly assigned to receive propofol or dexmedetomidine for sedation while they require ventilatory support. All patients will also receive the pain medication fentanyl as needed.
- Conditions
- Mechanical Ventilation, Critical Illness
- Being tested
- Dexmedetomidine, Propofol, Fentanyl, Midazolam, Physical and Occupational Therapy
- Keywords
- Hypnotics and Sedatives, Respiration, Artificial, Ventilators, Mechanical, Critical care, Intensive care, Physical therapy, Occupational therapy, Sedative medications
- Medical subject headings
- Critical Illness, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS
PropofolDrug
Also called Diprivan
continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS
FentanylDrug
25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale
MidazolamDrug
Also called Versed
0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)
Physical and Occupational TherapyBehavioural
Daily therapy sessions targeting range of motion, strength, and mobility
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Active comparator | Patients in this arm will receive continuous dexmedetomidine infusion (0.2 - 1.5 mcg/kg/hour) titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first. Receives: Drug: Dexmedetomidine; Drug: Fentanyl; Drug: Midazolam; Behavioral: Physical and Occupational Therapy |
| Propofol | Active comparator | Patients in this arm will receive propofol (5 - 50 mcg/kg/min) for sedation, titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first. Receives: Drug: Propofol; Drug: Fentanyl; Drug: Midazolam; Behavioral: Physical and Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Days With Delirium
delirium assessment using CAM-ICU
Measured: daily up to 28 days
Secondary outcomes (11)
Drug Efficacy According to Richmond Agitation Sedation Scale (RASS) Score
Richmond Agitation Sedation Scale (RASS). This is a validated scale that measures level of sedation. The scale ranges from -5 to +4. -5 refers to a state where one is unarousable, +4 refers to a state where one is combative. The median and inter-quartile range over all daily assessments will be provided.
Measured: Daily up to day 28
Number of Patients Completing Mobility Milestones
Milestones: sitting upright independently, standing independently, transfer to chair, marching in place, ambulating independently
Measured: Daily through day 28
Days on Ventilator
Measured: 60 days from enrollment
Days in ICU
Measured: 60 days from enollment
Mortality
Measured: 28 days from enrollment
Number of Participants With ICU Complications
Measured: daily through day 28
Number of Patients Requiring Fentanyl
Measured: during infusion of study medication up to day 28
Number of Patients Requiring Midazolam
Measured: during infusion of study medication through day 28
Days in Hospital
Measured: 60 days from enrollment
Number of Patients Completing Activities of Daily Living
activities of daily living: eating, bathing, dressing, grooming, toileting
Measured: daily through day 28
Number of Adverse Medication Effects
Measured: duration of infusion of study medication up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2010 (estimated)
- Study startSep 2009
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: drug and placebo unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Hospira, now a wholly owned subsidiary of Pfizer
- Responsible party
- Sponsor
- Investigators
- John P Kress, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01059929
- Sponsor's protocol ID
- 16865B
- Status last verified
- Jul 2018
- First submitted
- 14 Sep 2009
- Last updated
- 3 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blinded Randomized Controlled Trial of Dexmedetomidine Versus Propofol for Sedation in Mechanically Ventilated Medical Intensive Care Unit Patients.
- ClinicalTrials.gov ID
- NCT01059929
- Acronym / sponsor ID
- 16865B
- Conditions
- Mechanical Ventilation, Critical Illness
- Keywords
- Hypnotics and Sedatives, Respiration, Artificial, Ventilators, Mechanical, Critical care, Intensive care, Physical therapy, Occupational therapy, Sedative medications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: drug and placebo unavailable
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Hospira, now a wholly owned subsidiary of Pfizer
- Study start
- Sep 2009
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 1 Feb 2010 (estimated)
- Results
- Posted 3 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled trial to compare propofol to dexmedetomidine for prolonged sedation (> 24 hours) in critically ill patients who require mechanical ventilation.
Detailed description
Mechanically ventilated critically ill patients are routinely given sedative and analgesic medications to relieve pain and anxiety associated with intubation, mechanical ventilation, and critical care in general. While integral in minimizing discomfort, these medications may increase mechanical ventilation time, the duration of intensive care unit (ICU) stay, ICU complications (e.g. delirium, ventilator associated pneumonia, venous thromboembolism), the morbidity associated with critical illness, and patient mortality. This study compares two sedative medications that have been used in patients who require a mechanical ventilator. Enrolled patients will be randomly assigned to receive propofol or dexmedetomidine for sedation while they require ventilatory support. All patients will also receive the pain medication fentanyl as needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Active comparator | Drug: Dexmedetomidine, Drug: Fentanyl, Drug: Midazolam, Behavioral: Physical and Occupational TherapyPatients in this arm will receive continuous dexmedetomidine infusion (0.2 - 1.5 mcg/kg/hour) titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first. |
| Propofol | Active comparator | Drug: Propofol, Drug: Fentanyl, Drug: Midazolam, Behavioral: Physical and Occupational TherapyPatients in this arm will receive propofol (5 - 50 mcg/kg/min) for sedation, titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >18 years old
- mechanically ventilated through endotracheal tube
- anticipated need for ventilation > 48 hours
- requiring sedative/analgesic medication
Key exclusion criteria (9 listed)
- on mechanical ventilator > 96 hours
- primary neurologic disease
- post cardiac arrest
- do not speak English (assessment only English language validated)
- pregnancy or lactation
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: Precedexcontinuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS | Drug | Dexmedetomidine |
| PropofolAlso: Diprivancontinuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS | Drug | Propofol |
| Fentanyl25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale | Drug | Dexmedetomidine, Propofol |
| MidazolamAlso: Versed0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2) | Drug | Dexmedetomidine, Propofol |
| Physical and Occupational TherapyDaily therapy sessions targeting range of motion, strength, and mobility | Behavioural | Dexmedetomidine, Propofol |
Primary outcome
Proportion of Days With Delirium
Time frame: daily up to 28 days
delirium assessment using CAM-ICU
11 secondary outcomes
Drug Efficacy According to Richmond Agitation Sedation Scale (RASS) Score
Time frame: Daily up to day 28
Number of Patients Completing Mobility Milestones
Time frame: Daily through day 28
Days on Ventilator
Time frame: 60 days from enrollment
Days in ICU
Time frame: 60 days from enollment
Mortality
Time frame: 28 days from enrollment
Number of Participants With ICU Complications
Time frame: daily through day 28
Number of Patients Requiring Fentanyl
Time frame: during infusion of study medication up to day 28
Number of Patients Requiring Midazolam
Time frame: during infusion of study medication through day 28
Days in Hospital
Time frame: 60 days from enrollment
Number of Patients Completing Activities of Daily Living
Time frame: daily through day 28
Number of Adverse Medication Effects
Time frame: duration of infusion of study medication up to 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
John P Kress, MD principal investigator
University of Chicago
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, Propofol and Fentanyl in people with Mechanical Ventilation and Critical Illness, run by University of Chicago 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 9 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: stopped early, as of the sponsor's last update on 3 Jul 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. 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?
Yes. Results are posted in the registry (first posted 3 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Days With Delirium (time frame: daily up to 28 days). 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 3 Jul 2018.