A Research Study to Evaluate the Effectiveness of Dexmedetomidine in Preventing Delirium After Hip Fracture Repair Surgery
NCT ID: NCT00460473
Last Updated: 2015-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
52 participants
INTERVENTIONAL
2007-04-30
2007-11-30
Brief Summary
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Detailed Description
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Dexmedetomidine is currently approved for use for 24 hours in patients on ventilators in the ICU. Study participation will last from within 72 hours of surgery to 3 days after surgery, continue throughout surgery and up to 2 hours after surgery. Delirium will be assessed prior to surgery and for 72 hours after surgery. This assessment will consist of questions to determine memory and thought process. At discharge patient's resource utilization will be evaluated and thirty days after surgery questions will be asked regarding quality of life.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Dexmedetomidine
Dexmedetomidine
Placebo (PBO)
Placebo
Interventions
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Dexmedetomidine
Placebo
Eligibility Criteria
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Inclusion Criteria
2. If female, subject is non-lactating and is either:
1. Not of childbearing potential, defined as post-menopausal for at least 1 year or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy or hysterectomy.
2. Of childbearing potential but is not pregnant at time of baseline and is practicing one of the following methods of birth control: oral or parenteral contraceptives, double-barrier method, vasectomized partner, or abstinence from sexual intercourse.
3. Subject is American Society of Anesthesiologists Physical Status I, II, III, or IV.
4. Subject (or subject's legally authorized representative) has voluntarily signed and dated the informed consent document approved by the Institutional Review Board (IRB).
Exclusion Criteria
2. Subject has a positive CAM-ICU result for delirium at Screening or Baseline.
3. Subject requires chronic antipsychotic therapy.
4. Subject is anticipated to require additional surgical procedures during the 72 hour Screening Period and the 3 days Follow-up Period.
5. Subject is anticipated to require repair of pelvic fractures (eg,acetabulum).
6. Subject has participated in a trial with any experimental drug or experimental implantable device within 30 days prior to the study drug administration, or has ever been enrolled in this study.
7. Subject known to be in liver failure.
8. Subject has an anticipated potential for increased intracranial pressure or an uncontrolled seizure disorder or known psychiatric illness that could confound a normal response during study assessment.
9. Subject has received treatment with a α2-agonist or antagonist (within 14 days of study entry).
10. Subject for whom opiates, benzodiazepines, DEX or other α2-agonists are contraindicated.
11. Subject has, per the investigator's judgment, a known or suspected physical or psychological dependence on an abused drug, other than alcohol.
12. Subject has acute unstable angina, acute myocardial infarction, HR \<50 bpm, SBP \<90 mmHg, or third degree heart block unless the subject has a pacemaker.
13. Subject has any condition or factor which, in the Investigator's opinion, might increase the risk to the subject.
14. Subject is not expected to live more than 60 days.
18 Years
ALL
No
Sponsors
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Hospira, now a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
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Locations
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Loma Linda University Medical Center
Loma Linda, California, United States
LAC-USC Medical Center Los Angeles
Los Angeles, California, United States
Huntington Memorial Hospital
Pasadena, California, United States
University of Miami-Jackson Memorial Medical Center
Miami, Florida, United States
Southeastern Clinical Research Consultants
Orlando, Florida, United States
Orlando Regional Healthcare, Critical Care Medicine
Orlando, Florida, United States
G and G Research, Inc.
Vero Beach, Florida, United States
Orthopaedic Center of Vero Beach
Vero Beach, Florida, United States
Medical College of Georgia
Augusta, Georgia, United States
University of Iowa Hospitals and Clinics, Dept. of Anesthesia
Iowa City, Iowa, United States
Outcomes Research Institute
Louisville, Kentucky, United States
Louisiana State University, Dept. of Orthopaedic Surgery
Shreveport, Louisiana, United States
Spectrum Health Blodgett Campus
Grand Rapids, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Saint Mary's Duluth Clinic Health System
Duluth, Minnesota, United States
Mayo Clinic College of Medicine, Dept. of Anesthesiology
Rochester, Minnesota, United States
University of Missouri
Columbia, Missouri, United States
Mount Sinai School of Medicine
Great Neck, New York, United States
New York University Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
University of Pittsburgh Medical Center, Presbyterian
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Research Concepts
Bellaire, Texas, United States
Parkland Health and Hospital System
Dallas, Texas, United States
University of Virginia Health Systems
Charlottesville, Virginia, United States
University of Wisconsin Medical School, Dept. of Anesthesiology
Madison, Wisconsin, United States
VA Medical Center
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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DEX-06-09
Identifier Type: -
Identifier Source: org_study_id
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