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:
Hospira, Inc.
Information provided by:
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT00464763
First received: April 23, 2007
Last updated: November 9, 2007
Last verified: November 2007
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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 |
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
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 May 19, 2013