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

This study has been withdrawn prior to enrollment.
(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.)
Sponsor:
Information provided by:
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT00464763
First received: April 23, 2007
Last updated: July 23, 2015
Last verified: July 2015
  Purpose

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 Intervention Phase
Delirium
Drug: Dexmedetomidine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Hospira, Inc.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
    The presence of postoperative delirium will be determined by the Confusion Assessment Method (CAM-ICU)


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

Enrollment: 0
Study Start Date: April 2007
Study Completion Date: September 2007
Arms Assigned Interventions
Experimental: Dexmedetomidine Drug: Dexmedetomidine
Placebo Comparator: Placebo (PBO)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00464763

Locations
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, Inc.
Investigators
Study Director: Paula Bokesch, MD Hospira, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00464763     History of Changes
Other Study ID Numbers: DEX-06-06
Study First Received: April 23, 2007
Last Updated: July 23, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Hospira, Inc.:
Mental Health
Neurological Disease
Heart Valve Repair Surgery

Additional relevant MeSH terms:
Delirium
Confusion
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Dexmedetomidine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Analgesics, Non-Narcotic
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2015