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

Withdrawn before enrolling · Phase 3 · Has a placebo group

Conditions studied: Delirium

In brief

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).

Key facts

Study ID

NCT00464763

Run by

Hospira, now a wholly owned subsidiary of Pfizer

People needed

0

Starts

2007-04-01

Expected to finish

2007-09-01

Last updated by the study team

2017-03-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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.
• 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).

You may not qualify if…

• 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.

Where it is running

• Loma Linda University — Loma Linda, California, United States
• Midatlantic Cardiovascular Associates — Towson, Maryland, United States
• Genesys Cardiovascular and Thoracic Surgical Associates — Grand Blanc, Michigan, United States
• Cooper University Hospital — Camden, New Jersey, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Cardiothoracic and Vascular Surgical Specialists — Columbus, Ohio, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Baylor University Medical Center — Dallas, Texas, United States
• Texas Heart Institute — Houston, Texas, United States
• University of Virginia Health System, Dept. of Anesthesiology — Charlottesville, Virginia, United States
• Santara Norfolk General Hospital — Norfolf, Virginia, United States

Full record on ClinicalTrials.gov

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