Back to resultsA Research Study to Evaluate the Effectiveness of Dexmedetomidine in Preventing Delirium After Heart Surgery
Primary Purpose
Delirium
Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Dexmedetomidine
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Delirium focused on measuring Mental Health, Neurological Disease, Heart Valve Repair Surgery
Eligibility 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:
- 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).
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.
Sites / Locations
- Loma Linda University
- Midatlantic Cardiovascular Associates
- Genesys Cardiovascular and Thoracic Surgical Associates
- Cooper University Hospital
- Cleveland Clinic
- Cardiothoracic and Vascular Surgical Specialists
- University of Pittsburgh Medical Center
- Baylor University Medical Center
- Texas Heart Institute
- University of Virginia Health System, Dept. of Anesthesiology
- Santara Norfolk General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dexmedetomidine
Placebo (PBO)
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Daily percentage of subjects who experienced postoperative delirium
Duration of postoperative delirium as determined by CAM-ICU up to 3 days post surgery
Postoperative use of all analgesics
Time to extubation after arrival in ICU
Length of ICU stay
Full Information
NCT ID
NCT00464763
First Posted
April 23, 2007
Last Updated
March 20, 2017
Sponsor
Hospira, now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00464763
Brief Title
A Research Study to Evaluate the Effectiveness of Dexmedetomidine in Preventing Delirium After Heart Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Withdrawn
Why Stopped
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.
Study Start Date
April 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospira, now a wholly owned subsidiary of Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
Keywords
Mental Health, Neurological Disease, Heart Valve Repair Surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexmedetomidine
Arm Type
Experimental
Arm Title
Placebo (PBO)
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Percentage of subjects who experienced any postoperative delirium up to 3 days following surgery
Description
The presence of postoperative delirium will be determined by the Confusion Assessment Method (CAM-ICU)
Time Frame
Postoperative period (3-days): Twice daily (6:00 - 9:00 AM and 5:00 - 8:00 PM)
Secondary Outcome Measure Information:
Title
Daily percentage of subjects who experienced postoperative delirium
Time Frame
At each day during 3-day postoperative delirium
Title
Duration of postoperative delirium as determined by CAM-ICU up to 3 days post surgery
Time Frame
Up to 3 days post surgery
Title
Postoperative use of all analgesics
Time Frame
During postextubation period (Approximately 3 days)
Title
Time to extubation after arrival in ICU
Time Frame
From the time of ICU arrival to the time of ICU discharge (Approximately 3 days)
Title
Length of ICU stay
Time Frame
From the time of ICU arrival to the time of ICU discharge (Approximately 3 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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:
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).
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula Bokesch, MD
Organizational Affiliation
Hospira, now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Midatlantic Cardiovascular Associates
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204-7582
Country
United States
Facility Name
Genesys Cardiovascular and Thoracic Surgical Associates
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Cardiothoracic and Vascular Surgical Specialists
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Heart Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Virginia Health System, Dept. of Anesthesiology
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908-0710
Country
United States
Facility Name
Santara Norfolk General Hospital
City
Norfolf
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
12. IPD Sharing Statement
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A Research Study to Evaluate the Effectiveness of Dexmedetomidine in Preventing Delirium After Heart Surgery
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