Back to resultsA Research Study to Evaluate the Effectiveness of Dexmedetomidine in Preventing Delirium After Hip Fracture Repair Surgery
Primary Purpose
Delirium
Status
Terminated
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, Hip Injuries and Disorders
Eligibility Criteria
Inclusion Criteria:
- Adult (≥18 years old) male or female who will undergo surgery for fractured hip with general anesthesia within 72 hours of admission to hospital.
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, double-barrier method, vasectomized partner, or abstinence from sexual intercourse.
- Subject is American Society of Anesthesiologists Physical Status I, 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.
- Subject has a positive CAM-ICU result for delirium at Screening or Baseline.
- Subject requires chronic antipsychotic therapy.
- Subject is anticipated to require additional surgical procedures during the 72 hour Screening Period and the 3 days Follow-up Period.
- Subject is anticipated to require repair of pelvic fractures (eg,acetabulum).
- 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 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 received treatment with a α2-agonist or antagonist (within 14 days of study entry).
- Subject for whom opiates, benzodiazepines, DEX 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 acute unstable angina, acute myocardial infarction, HR <50 bpm, SBP <90 mmHg, or third degree heart block unless the subject has a pacemaker.
- 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 Medical Center
- LAC-USC Medical Center Los Angeles
- Huntington Memorial Hospital
- University of Miami-Jackson Memorial Medical Center
- Southeastern Clinical Research Consultants
- Orlando Regional Healthcare, Critical Care Medicine
- G and G Research, Inc.
- Orthopaedic Center of Vero Beach
- Medical College of Georgia
- University of Iowa Hospitals and Clinics, Dept. of Anesthesia
- Outcomes Research Institute
- Louisiana State University, Dept. of Orthopaedic Surgery
- Spectrum Health Blodgett Campus
- William Beaumont Hospital
- Saint Mary's Duluth Clinic Health System
- Mayo Clinic College of Medicine, Dept. of Anesthesiology
- University of Missouri
- Mount Sinai School of Medicine
- New York University Medical Center
- Duke University Medical Center
- The Cleveland Clinic Foundation
- Ohio State University Medical Center
- University of Pittsburgh Medical Center, Presbyterian
- University of Pittsburgh Medical Center
- Vanderbilt University Medical Center
- Research Concepts
- Parkland Health and Hospital System
- University of Virginia Health Systems
- University of Wisconsin Medical School, Dept. of Anesthesiology
- VA Medical Center
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 after the end of study drug infusion
The presence of postoperative delirium will be determined by Confusion Assessment Method for the Intensive Care Unit (CAM-ICU).
Secondary Outcome Measures
Duration of postoperative delirium as determined by CAM-ICU up to 3 days after end of study drug infusion
Percentage of subjects who experienced postoperative delirium each day after end of study drug infusion
Perioperative use of all analgesics (Fentanyl, Morphine, and oral analgesics)
Postoperative use of Midazolam
If RASS >0, midazolam (MDZ) 0.5-1 mg IV will be given until RASS <0. While in PACU during study drug infusion period, MDZ (0.5-1 mg IV) will be given if RASS >+1 under allowed maximum dose of study drug.
RASS range:
+4 Combative -Overtly combative, violent, immediate danger to staff
+3 Very agitated- Pulls or removes tubes or catheters, aggressive
+2 Agitated- Frequent non-purposeful movements, fights ventilator
+1 Restless- Anxious, but movements not aggressive or vigorous
0 Alert and calm
-1 Drowsy - Not fully alert, but sustained awakening (eye opening, eye contact) to voice (>10 sec)
-2 Light sedation - Briefly awakens with eye contact to voice (<10 sec)
-3 Moderate sedation - Movement or eye opening to voice (but no eye contact)
-4 Deep sedation No response to voice, but movement or eye opening to physical stimulation
-5 Unarousable No response to voice or physical stimulation
Time-to-Aldrete score of ≥9
A score of 9-10 indicates the subject has recovered from anesthesia and is ready for discharge from the PACU.
Length of post-operative hospital stay
Full Information
NCT ID
NCT00460473
First Posted
April 13, 2007
Last Updated
July 23, 2015
Sponsor
Hospira, now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00460473
Brief Title
A Research Study to Evaluate the Effectiveness of Dexmedetomidine in Preventing Delirium After Hip Fracture Repair 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 Surgery for Fractured Hip With General Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Terminated
Why Stopped
The incidence of post-operative delirium observed from interim blinded data was significantly lower than the current literature in this population.
Study Start Date
April 2007 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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 perioperative use of dexmedetomidine in the prevention of postoperative delirium in subjects undergoing surgery for fractured hip with general anesthesia.
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 morality. There are no drugs that are currently approved to prevent the onset of delirium but dexmedetomidine has the potential to meet this unmet medical need. Hip fractures, unfortunately are frequent occurrences in the elderly population and the elderly are more prone to developing delirium after surgery.
Dexmedetomidine is currently approved for use for 24 hours in patients on ventilators in the ICU. Study participation will last from within 72 hours of surgery to 3 days after surgery, continue throughout surgery and up to 2 hours after surgery. Delirium will be assessed prior to surgery and for 72 hours after surgery. This assessment will consist of questions to determine memory and thought process. At discharge patient's resource utilization will be evaluated and thirty days after surgery questions will be asked regarding quality of life.
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, Hip Injuries and Disorders
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (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 after the end of study drug infusion
Description
The presence of postoperative delirium will be determined by Confusion Assessment Method for the Intensive Care Unit (CAM-ICU).
Time Frame
Twice daily (between 6:00-9:00 AM and 5:00-8:00 PM) until 3 days after the end of study drug infusion.
Secondary Outcome Measure Information:
Title
Duration of postoperative delirium as determined by CAM-ICU up to 3 days after end of study drug infusion
Time Frame
Twice daily (between 6:00-9:00 AM and 5:00-8:00 PM) until 3 days after the end of study drug infusion.
Title
Percentage of subjects who experienced postoperative delirium each day after end of study drug infusion
Time Frame
Twice daily (between 6:00-9:00 AM and 5:00-8:00 PM) until 3 days after the end of study drug infusion.
Title
Perioperative use of all analgesics (Fentanyl, Morphine, and oral analgesics)
Time Frame
During the intraoperative period, Post-anesthesia care unit period and the 3 days Follow-up Period.
Title
Postoperative use of Midazolam
Description
If RASS >0, midazolam (MDZ) 0.5-1 mg IV will be given until RASS <0. While in PACU during study drug infusion period, MDZ (0.5-1 mg IV) will be given if RASS >+1 under allowed maximum dose of study drug.
RASS range:
+4 Combative -Overtly combative, violent, immediate danger to staff
+3 Very agitated- Pulls or removes tubes or catheters, aggressive
+2 Agitated- Frequent non-purposeful movements, fights ventilator
+1 Restless- Anxious, but movements not aggressive or vigorous
0 Alert and calm
-1 Drowsy - Not fully alert, but sustained awakening (eye opening, eye contact) to voice (>10 sec)
-2 Light sedation - Briefly awakens with eye contact to voice (<10 sec)
-3 Moderate sedation - Movement or eye opening to voice (but no eye contact)
-4 Deep sedation No response to voice, but movement or eye opening to physical stimulation
-5 Unarousable No response to voice or physical stimulation
Time Frame
During the PACU period (Approximately 2 hours)
Title
Time-to-Aldrete score of ≥9
Description
A score of 9-10 indicates the subject has recovered from anesthesia and is ready for discharge from the PACU.
Time Frame
Every 15±5 minutes from arrival in the PACU (Approximately 2 hours)
Title
Length of post-operative hospital stay
Time Frame
From the post operative period until subject discharged from hospital
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 surgery for fractured hip with general anesthesia within 72 hours of admission to hospital.
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, double-barrier method, vasectomized partner, or abstinence from sexual intercourse.
Subject is American Society of Anesthesiologists Physical Status I, 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.
Subject has a positive CAM-ICU result for delirium at Screening or Baseline.
Subject requires chronic antipsychotic therapy.
Subject is anticipated to require additional surgical procedures during the 72 hour Screening Period and the 3 days Follow-up Period.
Subject is anticipated to require repair of pelvic fractures (eg,acetabulum).
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 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 received treatment with a α2-agonist or antagonist (within 14 days of study entry).
Subject for whom opiates, benzodiazepines, DEX 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 acute unstable angina, acute myocardial infarction, HR <50 bpm, SBP <90 mmHg, or third degree heart block unless the subject has a pacemaker.
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.
Facility Information:
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
LAC-USC Medical Center Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Huntington Memorial Hospital
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
University of Miami-Jackson Memorial Medical Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33101
Country
United States
Facility Name
Southeastern Clinical Research Consultants
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Orlando Regional Healthcare, Critical Care Medicine
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
G and G Research, Inc.
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
Orthopaedic Center of Vero Beach
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
Medical College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
University of Iowa Hospitals and Clinics, Dept. of Anesthesia
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1053
Country
United States
Facility Name
Outcomes Research Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Louisiana State University, Dept. of Orthopaedic Surgery
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Spectrum Health Blodgett Campus
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49506-2810
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Saint Mary's Duluth Clinic Health System
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Mayo Clinic College of Medicine, Dept. of Anesthesiology
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55906
Country
United States
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Mount Sinai School of Medicine
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
New York University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Pittsburgh Medical Center, Presbyterian
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213-2582
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Research Concepts
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Parkland Health and Hospital System
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9179
Country
United States
Facility Name
University of Virginia Health Systems
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908-0710
Country
United States
Facility Name
University of Wisconsin Medical School, Dept. of Anesthesiology
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
VA Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Research Study to Evaluate the Effectiveness of Dexmedetomidine in Preventing Delirium After Hip Fracture Repair Surgery
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