Dexmedetomidine Versus Propofol in the Medical Intensive Care Unit (MICU)
NCT01059929
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- >18 years old
- mechanically ventilated through endotracheal tube
- anticipated need for ventilation > 48 hours
- requiring sedative/analgesic medication
- 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
- second or third degree heart block
- pancreatitis
- elevated serum triglycerides (> 400 mg/dL)
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Descriptive Information | ||||
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Brief Title ICMJE | Dexmedetomidine Versus Propofol in the Medical Intensive Care Unit (MICU) | |||
Official Title ICMJE | A Double-blinded Randomized Controlled Trial of Dexmedetomidine Versus Propofol for Sedation in Mechanically Ventilated Medical Intensive Care Unit Patients. | |||
Brief 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. | |||
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 Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE | 41 | |||
Original Estimated Enrollment ICMJE | 210 | |||
Actual Study Completion Date ICMJE | September 2015 | |||
Actual Primary Completion Date | September 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01059929 | |||
Other Study ID Numbers ICMJE | 16865B | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Responsible Party | University of Chicago | |||
Study Sponsor ICMJE | University of Chicago | |||
Collaborators ICMJE | Hospira, now a wholly owned subsidiary of Pfizer | |||
Investigators ICMJE |
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PRS Account | University of Chicago | |||
Verification Date | July 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |