DeliriumPhase 3NCT00460473
A Research Study to Evaluate the Effectiveness of Dexmedetomidine in Preventing Delirium After Hip Fracture Repair Surgery
A Phase 3 study testing Dexmedetomidine in people with Delirium, run by Hospira, now a wholly owned subsidiary of Pfizer at 30 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 30 sitesUnited States
- Study dates
- Apr 2007to Nov 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Medical College of Georgia
Augusta, Georgia, 30912
Research Concepts
Bellaire, Texas, 77401
University of Virginia Health Systems
Charlottesville, Virginia, 22908-0710
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
University of Missouri
Columbia, Missouri, 65212
Ohio State University Medical Center
Columbus, Ohio, 43210
Parkland Health and Hospital System
Dallas, Texas, 75390-9179
Saint Mary's Duluth Clinic Health System
Duluth, Minnesota, 55805
Duke University Medical Center
Durham, North Carolina, 27705
Spectrum Health Blodgett Campus
Grand Rapids, Michigan, 49506-2810
Mount Sinai School of Medicine
Great Neck, New York, 11021
University of Iowa Hospitals and Clinics, Dept. of Anesthesia
Iowa City, Iowa, 52242-1053
Loma Linda University Medical Center
Loma Linda, California, 92354
LAC-USC Medical Center Los Angeles
Los Angeles, California, 90033
Outcomes Research Institute
Louisville, Kentucky, 40202
University of Wisconsin Medical School, Dept. of Anesthesiology
Madison, Wisconsin, 53792
University of Miami-Jackson Memorial Medical Center
Miami, Florida, 33101
VA Medical Center
Milwaukee, Wisconsin, 53295
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
New York University Medical Center
New York, New York, 10016
Southeastern Clinical Research Consultants
Orlando, Florida, 32804
Orlando Regional Healthcare, Critical Care Medicine
Orlando, Florida, 32806
Huntington Memorial Hospital
Pasadena, California, 91105
University of Pittsburgh Medical Center, Presbyterian
Pittsburgh, Pennsylvania, 15213-2582
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Mayo Clinic College of Medicine, Dept. of Anesthesiology
Rochester, Minnesota, 55906
William Beaumont Hospital
Royal Oak, Michigan, 48073
Louisiana State University, Dept. of Orthopaedic Surgery
Shreveport, Louisiana, 71103
G and G Research, Inc.
Vero Beach, Florida, 32960
Orthopaedic Center of Vero Beach
Vero Beach, Florida, 32960
About this study
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
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.
Read the 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.
- Conditions
- Delirium
- Being tested
- Dexmedetomidine, Placebo
- Keywords
- Mental Health, Neurological Disease, Hip Injuries and Disorders
- Medical subject headings
- Delirium, Psychological Well-Being, Nervous System Diseases, Hip Injuries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Not described Receives: Drug: Dexmedetomidine |
| Placebo (PBO) | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 outcomes (6)
Duration of postoperative delirium as determined by CAM-ICU up to 3 days after end of study drug infusion
Measured: Twice daily (between 6:00-9:00 AM and 5:00-8:00 PM) until 3 days after the end of study drug infusion.
Percentage of subjects who experienced postoperative delirium each day after end of study drug infusion
Measured: Twice daily (between 6:00-9:00 AM and 5:00-8:00 PM) until 3 days after the end of study drug infusion.
Perioperative use of all analgesics (Fentanyl, Morphine, and oral analgesics)
Measured: During the intraoperative period, Post-anesthesia care unit period and the 3 days Follow-up Period.
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
Measured: During the PACU period (Approximately 2 hours)
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.
Measured: Every 15±5 minutes from arrival in the PACU (Approximately 2 hours)
Length of post-operative hospital stay
Measured: From the post operative period until subject discharged from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionNov 2007
- Study completionNov 2007
Why it stopped: The incidence of post-operative delirium observed from interim blinded data was significantly lower than the current literature in this population.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460473
- Sponsor's protocol ID
- DEX-06-09
- Status last verified
- Jul 2015
- First submitted
- 13 Apr 2007
- Last updated
- 24 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00460473
- Acronym / sponsor ID
- DEX-06-09
- Conditions
- Delirium
- Keywords
- Mental Health, Neurological Disease, Hip Injuries and Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The incidence of post-operative delirium observed from interim blinded data was significantly lower than the current literature in this population.
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hospira, now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 16 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: Dexmedetomidine |
| Placebo (PBO) | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- 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).
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine | Drug | Dexmedetomidine |
| Placebo | Drug | Placebo (PBO) |
Primary outcome
Percentage of subjects who experienced any postoperative delirium up to 3 days after the 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.
The presence of postoperative delirium will be determined by Confusion Assessment Method for the Intensive Care Unit (CAM-ICU).
6 secondary outcomes
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.
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.
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.
Postoperative use of Midazolam
Time frame: During the PACU period (Approximately 2 hours)
Time-to-Aldrete score of ≥9
Time frame: Every 15±5 minutes from arrival in the PACU (Approximately 2 hours)
Length of post-operative hospital stay
Time frame: From the post operative period until subject discharged from hospital
Results and safety
The study was stopped early (reason given: The incidence of post-operative delirium observed from interim blinded data was significantly lower than the current literature in this population.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine in people with Delirium, run by Hospira, now a wholly owned subsidiary of Pfizer at 30 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The incidence of post-operative delirium observed from interim blinded data was significantly lower than the current literature in this population.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects who experienced any postoperative delirium up to 3 days after the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2015.