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

NCT00464763 | Withdrawn Phase 3

• 1 other identifier: DEX-06-06
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 11

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).

Conditions

Delirium

Keywords

Mental Health; Neurological Disease; Heart Valve Repair Surgery

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects who experienced any postoperative delirium up to 3 days following surgery

  The presence of postoperative delirium will be determined by the Confusion Assessment Method (CAM-ICU)

  Postoperative period (3-days): Twice daily (6:00 - 9:00 AM and 5:00 - 8:00 PM)

Secondary Outcomes (5)

• Daily percentage of subjects who experienced postoperative delirium

  At each day during 3-day postoperative delirium

• Duration of postoperative delirium as determined by CAM-ICU up to 3 days post surgery

  Up to 3 days post surgery

• Postoperative use of all analgesics

  During postextubation period (Approximately 3 days)

• Time to extubation after arrival in ICU

  From the time of ICU arrival to the time of ICU discharge (Approximately 3 days)

• Length of ICU stay

  From the time of ICU arrival to the time of ICU discharge (Approximately 3 days)

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

Drug: Dexmedetomidine

Placebo (PBO)

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Dexmedetomidine DRUG

Dexmedetomidine

Placebo DRUG

Placebo (PBO)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Hospira, now a wholly owned subsidiary of Pfizer: lead

Study Sites (11)

Loma Linda University

Loma Linda, California, 92354, United States

Location

Midatlantic Cardiovascular Associates

Towson, Maryland, 21204-7582, United States

Location

Genesys Cardiovascular and Thoracic Surgical Associates

Grand Blanc, Michigan, 48439, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Cardiothoracic and Vascular Surgical Specialists

Columbus, Ohio, 43214, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Texas Heart Institute

Houston, Texas, 77030, United States

Location

University of Virginia Health System, Dept. of Anesthesiology

Charlottesville, Virginia, 22908-0710, United States

Location

Santara Norfolk General Hospital

Norfolf, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Delirium; Psychological Well-Being; Nervous System Diseases

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Paula Bokesch, MD

  Hospira, now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 23, 2007
• First Posted: April 24, 2007
• Study Start: April 1, 2007
• Study Completion: September 1, 2007
• Last Updated: March 21, 2017

Record last verified: 2015-11

Locations

US (11)