SedationPhase 4NCT00852046
Adjunct Dexmedetomidine (Precedex®) Therapy Impact on Sedative and Analgesic Requirement
A Phase 4 study testing Dexmedetomidine in people with Sedation and Analgesia, run by Avera McKennan Hospital & University Health Center.
Trial summary
Assess impact of increasing dose of dexmedetomidine on total daily dose of fentanyl and propofol while maintaining sedation in a mechanically ventilated patient in a general medical intensive care unit. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Mar 2009
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- surgical, medical, or trauma patients requiring sedation for mechanical ventilation
- age 18-80
- Anticipated ventilation time of > 24 hrs
- Reasonable chance of recovery
Who cannot join
- Severe COPD
- Chronic immunosuppression (equivalent to prednisone 7.5 mg daily or higher)
- Heart block
- Bradycardia
- Significant head injury
- Goal SAS score of 1-2
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- Severe hepatic impairment
- Hypertriglyceridemia
- Allergy to dexmedetomidine, fentanyl, propofol or eggs
About this study
Official title: Adjunct Dexmedetomidine Therapy Impact on Sedative and Analgesic
Assess impact of increasing dose of dexmedetomidine on total daily dose of fentanyl and propofol while maintaining sedation in a mechanically ventilated patient in a general medical intensive care unit.
Read the detailed description
Patients identified by selection criteria within 48 hours of intubation will be randomly assigned to one of three study arms: dexmedetomidine 0.2 mcg/kg/hr, dexmedetomidine 0.6 mcg/kg/hr, or placebo. If not already on, patients will be converted to propofol and fentanyl for sedation and analgesia, which will be titrated to a goal SAS score of 3-4.
Patients will be monitored, assessed, and evaluated by all regular policies and procedures of the institution. Extubation will be at the discretion of the physicians and medical team caring for the patient. If the patient is still intubated at five days study drug will then be stopped and further use of dexmedetomidine will be at the discretion of the physicians.
Primary objective will assess impact of increasing dose of dexmedetomidine on total daily dose of fentanyl and propofol while maintaining sedation in a mechanically ventilated patient in a general medical intensive care unit.
Secondary objectives include total ventilation time, ICU length of stay, hospital length of stay, patient outcomes/mortality, and total pharmacy expenditures.
- Being tested
- Dexmedetomidine
- Keywords
- Mechanical ventilation
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
IV solution, 0.2 mcg/kg/hr or 0.6 mcg/kg/hr for a max of 5 days
| Study group | Role | What they receive |
|---|---|---|
| 1. Low dose dexmedetomidine | Experimental | Dexmedetomidine 0.2 mcg/kg/hr added to fentanyl \& propofol. Receives: Drug: Dexmedetomidine |
| 2. High dose dexmedetomidine | Experimental | Dexmedetomidine 0.6 mcg/kg/hr added to fentanyl \& propofol. Receives: Drug: Dexmedetomidine |
| 3. Placebo | Placebo comparator | Placebo added to fentanyl \& propofol. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total daily dose of fentanyl and propofol
Measured: Daily
Secondary outcomes (5)
Total ventilation time
Measured: Study ended
ICU length of stay
Measured: Study ended.
Hospital length of stay
Measured: Study ended
Patient outcomes/mortality
Measured: Study ended.
Total pharmacy expenditures
Measured: Study ended.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionMar 2009
- Study completionMar 2009
Why it stopped: PI resigned.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SedationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avera McKennan Hospital & University Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John A Kappes, Pharm.D., Principal investigator, Avera McKennan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852046
- Sponsor's protocol ID
- #2008.071
- Status last verified
- Jul 2011
- First submitted
- 24 Feb 2009
- Last updated
- 6 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunct Dexmedetomidine Therapy Impact on Sedative and Analgesic
- ClinicalTrials.gov ID
- NCT00852046
- Acronym / sponsor ID
- #2008.071
- Keywords
- Mechanical ventilation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI resigned.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Avera McKennan Hospital & University Health CenterUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 26 Feb 2009 (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.
Assess impact of increasing dose of dexmedetomidine on total daily dose of fentanyl and propofol while maintaining sedation in a mechanically ventilated patient in a general medical intensive care unit.
Detailed description
Patients identified by selection criteria within 48 hours of intubation will be randomly assigned to one of three study arms: dexmedetomidine 0.2 mcg/kg/hr, dexmedetomidine 0.6 mcg/kg/hr, or placebo. If not already on, patients will be converted to propofol and fentanyl for sedation and analgesia, which will be titrated to a goal SAS score of 3-4.
Patients will be monitored, assessed, and evaluated by all regular policies and procedures of the institution. Extubation will be at the discretion of the physicians and medical team caring for the patient. If the patient is still intubated at five days study drug will then be stopped and further use of dexmedetomidine will be at the discretion of the physicians.
Primary objective will assess impact of increasing dose of dexmedetomidine on total daily dose of fentanyl and propofol while maintaining sedation in a mechanically ventilated patient in a general medical intensive care unit.
Secondary objectives include total ventilation time, ICU length of stay, hospital length of stay, patient outcomes/mortality, and total pharmacy expenditures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1. Low dose dexmedetomidine | Experimental | Drug: DexmedetomidineDexmedetomidine 0.2 mcg/kg/hr added to fentanyl \& propofol. |
| 2. High dose dexmedetomidine | Experimental | Drug: DexmedetomidineDexmedetomidine 0.6 mcg/kg/hr added to fentanyl \& propofol. |
| 3. Placebo | Placebo comparator | Drug: DexmedetomidinePlacebo added to fentanyl \& propofol. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- surgical, medical, or trauma patients requiring sedation for mechanical ventilation
- age 18-80
- Anticipated ventilation time of > 24 hrs
- Reasonable chance of recovery
Key exclusion criteria (9 listed)
- Severe COPD
- Chronic immunosuppression (equivalent to prednisone 7.5 mg daily or higher)
- Heart block
- Bradycardia
- Significant head injury
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 |
|---|---|---|
| DexmedetomidineAlso: PrecedexIV solution, 0.2 mcg/kg/hr or 0.6 mcg/kg/hr for a max of 5 days | Drug | 1. Low dose dexmedetomidine, 2. High dose dexmedetomidine, 3. Placebo |
Primary outcome
Total daily dose of fentanyl and propofol
Time frame: Daily
5 secondary outcomes
Total ventilation time
Time frame: Study ended
ICU length of stay
Time frame: Study ended.
Hospital length of stay
Time frame: Study ended
Patient outcomes/mortality
Time frame: Study ended.
Total pharmacy expenditures
Time frame: Study ended.
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 6 Oct 2011.
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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.
John A Kappes, Pharm.D. principal investigator
Avera McKennan Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine in people with Sedation and Analgesia, run by Avera McKennan Hospital & University Health Center.
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 4 inclusion and 9 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 6 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Total daily dose of fentanyl and propofol (time frame: Daily). 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 6 Oct 2011.