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A Research Study to Evaluate the Effectiveness of Dexmedetomidine in Preventing Delirium After Heart Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00464763
Recruitment Status : Withdrawn (The incidence of post-operative delirium observed from interim blinded data in DEX-06-09 was significantly lower than the current literature in this population.)
First Posted : April 24, 2007
Last Update Posted : March 21, 2017
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of dexmedetomidine in the prevention of postoperative delirium in subjects undergoing heart valve surgery with or without coronary artery bypass surgery (CABG) using cardiopulmonary bypass (CPB).

Condition or disease Intervention/treatment Phase
Delirium Drug: Dexmedetomidine Drug: Placebo Phase 3

Detailed Description:

Postoperative delirium is an acute decline in cognition and attention which is usually transient but when delirium persists, it can impact cognitive function, morbidity and mortality. Currently, there are no drugs to prevent delirium but dexmedetomidine has the potential to meet this unmet medical need.

Dexmedetomidine is currently approved for use for 24 hours in patients on ventilators in the Intensive Care Unit(ICU). This study is to determine whether or not dexmedetomidine can prevent delirium after heart surgery. Study participation will last from randomization prior to surgery, to 3 days after surgery. Dexmedetomidine will be given through an intravenous catheter beginning at sternal closure and continue throughout the stay in the ICU. Delirium will be assessed prior to surgery and for 72 hours after surgery. This assessment will consist of questions that will evaluate memory and thought process. Thirty days after surgery, questions will be asked regarding the patients feelings about their health status and hospital billing information will be collected.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Two-Arm Parallel, Multicenter Study Evaluating the Efficacy and Safety of Dexmedetomidine in the Prevention of Postoperative Delirium in Subjects Undergoing Heart Surgery With Cardiopulmonary Bypass
Study Start Date : April 2007
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Dexmedetomidine Drug: Dexmedetomidine
Placebo Comparator: Placebo (PBO) Drug: Placebo

Outcome Measures

Primary Outcome Measures :
  1. Percentage of subjects who experienced any postoperative delirium up to 3 days following surgery [ Time Frame: Postoperative period (3-days): Twice daily (6:00 - 9:00 AM and 5:00 - 8:00 PM) ]
    The presence of postoperative delirium will be determined by the Confusion Assessment Method (CAM-ICU)

Secondary Outcome Measures :
  1. Daily percentage of subjects who experienced postoperative delirium [ Time Frame: At each day during 3-day postoperative delirium ]
  2. Duration of postoperative delirium as determined by CAM-ICU up to 3 days post surgery [ Time Frame: Up to 3 days post surgery ]
  3. Postoperative use of all analgesics [ Time Frame: During postextubation period (Approximately 3 days) ]
  4. Time to extubation after arrival in ICU [ Time Frame: From the time of ICU arrival to the time of ICU discharge (Approximately 3 days) ]
  5. Length of ICU stay [ Time Frame: From the time of ICU arrival to the time of ICU discharge (Approximately 3 days) ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult (≥18 years old) male or female who will undergo elective heart valve surgery (with or without CABG and using CPB) with general anesthesia and require an overnight stay in the ICU following surgery.
  • 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, doublebarrier method, vasectomized partner, or abstinence from sexual intercourse.
  • Subject is American Society of Anesthesiologists (ASA) Physical Status II, III, or IV.
  • 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:

  • Cognitive function level by Mini Mental State Exam (MMSE) of ≤ 20 at screening.
  • Subject has a positive CAM-ICU result for delirium at Screening.
  • Subject requires chronic anti-psychotic therapy.
  • 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.
  • Subject is known to be in liver failure.
  • 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.
  • Subject has acute myocardial infarction, HR <50 bpm, SBP <90 mmHg, is hemodynamically unstable requiring systemic inotropic drugs or intra-aortic counterpulsation balloon pump within the last 72 hours.
  • Subject is anticipated to require hypothermic circulatory arrest during this surgical procedure.
  • Subject has received treatment with a α2-agonist or antagonist (within 14 days of study entry).
  • Subject for whom opiates, propofol, Dexmedetomidine or other α2-agonists are contraindicated.
  • Subject has, per the investigator's judgment, a known or suspected physical or psychological dependence on an abused drug, other than alcohol.
  • Subject has any condition or factor which, in the Investigator's opinion, might increase the risk to the subject.
  • Subject is not expected to live more than 60 days.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00464763

United States, California
Loma Linda University
Loma Linda, California, United States, 92354
United States, Maryland
Midatlantic Cardiovascular Associates
Towson, Maryland, United States, 21204-7582
United States, Michigan
Genesys Cardiovascular and Thoracic Surgical Associates
Grand Blanc, Michigan, United States, 48439
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Cardiothoracic and Vascular Surgical Specialists
Columbus, Ohio, United States, 43214
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
Texas Heart Institute
Houston, Texas, United States, 77030
United States, Virginia
University of Virginia Health System, Dept. of Anesthesiology
Charlottesville, Virginia, United States, 22908-0710
Santara Norfolk General Hospital
Norfolf, Virginia, United States, 23507
Sponsors and Collaborators
Hospira, now a wholly owned subsidiary of Pfizer
Study Director: Paula Bokesch, MD Hospira, now a wholly owned subsidiary of Pfizer
More Information

ClinicalTrials.gov Identifier: NCT00464763     History of Changes
Other Study ID Numbers: DEX-06-06
First Posted: April 24, 2007    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: November 2015

Keywords provided by Hospira, now a wholly owned subsidiary of Pfizer:
Mental Health
Neurological Disease
Heart Valve Repair Surgery

Additional relevant MeSH terms:
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action