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

This study has been terminated.
(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: November 9, 2007
Last verified: November 2007
  Purpose

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.


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
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:
  • Postoperative delirium

Secondary Outcome Measures:
  • Duration and percentage of delirium
  • Amount of analgesics used
  • Time to extubation after arrival in ICU
  • Length of time in ICU
  • Length of post-operative hospital stay

Estimated Enrollment: 304
Study Start Date: April 2007
Study Completion Date: November 2007
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult 18 years or older
  • Not pregnant or lactating
  • ASA II,III of IV

Exclusion Criteria:

  • MMSE 20 or less
  • Positive CAM -ICU
  • Chronic antipsychotic therapy
  • Participated in another clinical trial within 30 days
  • Known Liver failure
  • Increased intracranial pressure, uncontrolled seizures, psychiatric disorder that could confound a normal response to study assessments
  • Acute myocardial infarction, HR<50 bpm, SBP<90mmHg, is hemodynamically unstable requiring systemic inotropic drugs or intra-aortic counterpulsation balloon pump within the last 72 hours.
  • Received treatment with an alpha-2 agonist or antagonist within 14 days of study entry
  • Opiates, propofol, dexmedetomidine or other alph-2 agonists are contraindicated
  • Per investigator's opinion, a known or suspected physical or psychological dependence on an abused drug, other than alcohol
  • Per investigator's opinion study participation may increase risk to patient
  • 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, Ohio
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, Virginia
University of Virginia Health System, Dept. of Anesthesiology
Charlottesville, Virginia, United States, 22908-0710
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: November 9, 2007
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
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
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

ClinicalTrials.gov processed this record on August 28, 2014