DeliriumPhase 3NCT00464763
A Research Study to Evaluate the Effectiveness of Dexmedetomidine in Preventing Delirium After Heart Surgery
A Phase 3 study testing Dexmedetomidine in people with Delirium, run by Hospira, now a wholly owned subsidiary of Pfizer at 11 sites in United States.
Trial 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). 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
- 0 participants
- Where
- 11 sitesUnited States
- Study dates
- Apr 2007to Sep 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 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Cooper University Hospital
Camden, New Jersey, 08103
University of Virginia Health System, Dept. of Anesthesiology
Charlottesville, Virginia, 22908-0710
Cleveland Clinic
Cleveland, Ohio, 44195
Cardiothoracic and Vascular Surgical Specialists
Columbus, Ohio, 43214
Baylor University Medical Center
Dallas, Texas, 75246
Genesys Cardiovascular and Thoracic Surgical Associates
Grand Blanc, Michigan, 48439
Texas Heart Institute
Houston, Texas, 77030
Loma Linda University
Loma Linda, California, 92354
Santara Norfolk General Hospital
Norfolf, Virginia, 23507
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Midatlantic Cardiovascular Associates
Towson, Maryland, 21204-7582
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 Heart Surgery With Cardiopulmonary Bypass
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).
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 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.
- Conditions
- Delirium
- Being tested
- Dexmedetomidine, Placebo
- Keywords
- Mental Health, Neurological Disease, Heart Valve Repair Surgery
- Medical subject headings
- Delirium, Psychological Well-Being, Nervous System Diseases
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 following surgery
The presence of postoperative delirium will be determined by the Confusion Assessment Method (CAM-ICU)
Measured: Postoperative period (3-days): Twice daily (6:00 - 9:00 AM and 5:00 - 8:00 PM)
Secondary outcomes (5)
Daily percentage of subjects who experienced postoperative delirium
Measured: At each day during 3-day postoperative delirium
Duration of postoperative delirium as determined by CAM-ICU up to 3 days post surgery
Measured: Up to 3 days post surgery
Postoperative use of all analgesics
Measured: During postextubation period (Approximately 3 days)
Time to extubation after arrival in ICU
Measured: From the time of ICU arrival to the time of ICU discharge (Approximately 3 days)
Length of ICU stay
Measured: From the time of ICU arrival to the time of ICU discharge (Approximately 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2007 (estimated)
- Study startApr 2007
- Study completionSep 2007
Why it 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.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Paula Bokesch, MD, Study director, Hospira, now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00464763
- Sponsor's protocol ID
- DEX-06-06
- Status last verified
- Nov 2015
- First submitted
- 23 Apr 2007
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. 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 Heart Surgery With Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT00464763
- Acronym / sponsor ID
- DEX-06-06
- Conditions
- Delirium
- Keywords
- Mental Health, Neurological Disease, Heart Valve Repair Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospira, now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Study completion
- Sep 2007 (actual)
- First posted
- 24 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 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.
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 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:
- 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).
Key exclusion criteria (13 listed)
- 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.
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 following surgery
Time frame: Postoperative period (3-days): Twice daily (6:00 - 9:00 AM and 5:00 - 8:00 PM)
The presence of postoperative delirium will be determined by the Confusion Assessment Method (CAM-ICU)
5 secondary outcomes
Daily percentage of subjects who experienced postoperative delirium
Time frame: At each day during 3-day postoperative delirium
Duration of postoperative delirium as determined by CAM-ICU up to 3 days post surgery
Time frame: Up to 3 days post surgery
Postoperative use of all analgesics
Time frame: During postextubation period (Approximately 3 days)
Time to extubation after arrival in ICU
Time frame: From the time of ICU arrival to the time of ICU discharge (Approximately 3 days)
Length of ICU stay
Time frame: From the time of ICU arrival to the time of ICU discharge (Approximately 3 days)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
Related trials for Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
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.
Paula Bokesch, MD study director
Hospira, now a wholly owned subsidiary of Pfizer
11 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 11 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 13 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: withdrawn, as of the sponsor's last update on 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 withdrawn before enrolling participants, so there are no results.
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 following surgery (time frame: Postoperative period (3-days): Twice daily (6:00 - 9:00 AM and 5:00 - 8:00 PM)). 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 21 Mar 2017.