Endotracheal IntubationPhase 3C3PONCT01169467
Cerebral Perfusion Pressure Using Precedex and Other Sedatives
A Phase 3 study testing Standard-of-Care plus Dexmedetomidine and Standard-of-Care in people with Endotracheal Intubation and Continuous IV Sedation, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to examine the effects of using dexmedetomidine (Precedex) in addition to the current standard-of-care for sedation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endotracheal Intubation, Continuous IV Sedation, ICP Monitoring
- What is being tested?
- Standard-of-Care plus Dexmedetomidine and Standard-of-Care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Nov 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Admitted to Duke University Neuro Critical Care Unit (NCCU)
- Adult (18 years of age or older)
- Expected Mechanical Ventilation for >48 hours with sedation
- Intraventricular catheter in situ
Who cannot join
- Hypersensitivity to study drugs
- Prisoners
- Moribund state or death expected within 24 hours
- Surgery planned within 24 hours of subject enrollment
- Receiving study drug, Precedex, prior to entering study
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
The purpose of this study is to examine the effects of using dexmedetomidine (Precedex) in addition to the current standard-of-care for sedation.
Read the detailed description
Primarily, this study seeks to explore whether there is a difference in mean arterial pressure (MAP) variability, incidence of intracranial hypertension, intracranial pressure (ICP) variability, cerebral perfusion pressure (CPP) and Cerebrovascular pressure reactivity index (PRx) in two groups of subjects.
Patients must be submitted to the ICU and be endotracheally intubated and receiving mechanical ventilation with continuous IV sedation for less than 24 hours after recruitment into the study.
- Being tested
- Standard-of-Care plus Dexmedetomidine, Standard-of-Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard-of-Care plus DexmedetomidineDrug
Also called Precedex
Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
Standard-of-CareOther
Subjects who are treated with the standard of care sedation regiment only.
| Study group | Role | What they receive |
|---|---|---|
| Standard-of-Care plus Precedex | Active comparator | Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment. Receives: Drug: Standard-of-Care plus Dexmedetomidine |
| Standard-of-Care | Placebo comparator | Subjects who are treated with the standard of care sedation regiment only. Receives: Other: Standard-of-Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variability of Intracranial Pressure (ICP)
Variability of intracranial pressure was assessed and listed as the standard deviation of all measurements within 24 hours. Variability was assessed and listed as the standard deviation of all measurements within 24 hours
Measured: Baseline to 24 hours
Change in Pressure Reactivity Index (PRx)
Using computational methods, the PRx was determined by calculating the correlation coefficient between 20 consecutive, time-averaged data points (60-second periods) of ICP and Arterial Blood Pressure (ABP).
A positive PRx correlation suggests impaired cerebrovascular pressure reactivity, that is, passive transmission of changes in ABP to ICP. A negative PRx correlation indicates good pressure reactivity. Any change in ABP produces inverse changes in ICP.
Measured: Baseline to 24 hours
Secondary outcomes (3)
Amount of Sedative/Analgesic Used During Treatment in Patients With Secondary Brain Injury
Improved physiologic Response. A lower use of sedatives or analgesic during treatment would be considered an improved physiologic response. An increase in the use of sedatives or analgesic during treatment would be considered a worse physiologic response.
Measured: 24 hours
Cerebral Perfusion Pressure Changes in Patients With Secondary Brain Injury
Improved physiologic Response. A higher cerebral perfusion pressure during treatment would be considered an improved physiologic response. A lower cerebral perfusion pressure during treatment would be considered a worse physiologic response.
Measured: Baseline to 24 hours
Mean Arterial Blood Pressure (MAP) Variability in Patients With Secondary Brain Injury
Improved physiologic Response. A lower variability of mean Arterial Blood pressure during treatment would be considered an improved physiologic response. A higher variability of mean Arterial Blood pressure during treatment would be considered a worse physiologic response. Variability was assessed and listed as the standard deviation of all measurements within 24 hours.
Measured: Baseline to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2010 (estimated)
- Study startOct 2009
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endotracheal IntubationStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Hospira, now a wholly owned subsidiary of Pfizer
- Responsible party
- Sponsor
- Investigators
- Keith Dombrowski, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169467
- Sponsor's protocol ID
- Pro00018317
- Acronym
- C3PO
- Status last verified
- Oct 2015
- First submitted
- 22 Jul 2010
- Last updated
- 2 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Lazaridis C, DeSantis SM, Smielewski P, Menon DK, Hutchinson P, Pickard JD, Czosnyka M. Patient-specific thresholds of intracranial pressure in severe traumatic brain injury. J Neurosurg. 2014 Apr;120(4):893-900. doi: 10.3171/2014.1.JNS131292. Epub 2014 Feb 7.
PubMed 24506248
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Perfusion Pressure Using Precedex and Other Sedatives
- ClinicalTrials.gov ID
- NCT01169467
- Acronym / sponsor ID
- C3PO / Pro00018317
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Hospira, now a wholly owned subsidiary of Pfizer
- Study start
- Oct 2009
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 26 Jul 2010 (estimated)
- Results
- Posted 2 Nov 2015
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 examine the effects of using dexmedetomidine (Precedex) in addition to the current standard-of-care for sedation.
Detailed description
Primarily, this study seeks to explore whether there is a difference in mean arterial pressure (MAP) variability, incidence of intracranial hypertension, intracranial pressure (ICP) variability, cerebral perfusion pressure (CPP) and Cerebrovascular pressure reactivity index (PRx) in two groups of subjects.
Patients must be submitted to the ICU and be endotracheally intubated and receiving mechanical ventilation with continuous IV sedation for less than 24 hours after recruitment into the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard-of-Care plus Precedex | Active comparator | Drug: Standard-of-Care plus DexmedetomidineSubjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment. |
| Standard-of-Care | Placebo comparator | Other: Standard-of-CareSubjects who are treated with the standard of care sedation regiment only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Admitted to Duke University Neuro Critical Care Unit (NCCU)
- Adult (18 years of age or older)
- Expected Mechanical Ventilation for >48 hours with sedation
- Intraventricular catheter in situ
Key exclusion criteria (5 listed)
- Hypersensitivity to study drugs
- Prisoners
- Moribund state or death expected within 24 hours
- Surgery planned within 24 hours of subject enrollment
- Receiving study drug, Precedex, prior to entering study
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 |
|---|---|---|
| Standard-of-Care plus DexmedetomidineAlso: PrecedexSubjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment | Drug | Standard-of-Care plus Precedex |
| Standard-of-CareSubjects who are treated with the standard of care sedation regiment only. | Other | Standard-of-Care |
Primary outcome
Variability of Intracranial Pressure (ICP)
Time frame: Baseline to 24 hours
Variability of intracranial pressure was assessed and listed as the standard deviation of all measurements within 24 hours. Variability was assessed and listed as the standard deviation of all measurements within 24 hours
Change in Pressure Reactivity Index (PRx)
Time frame: Baseline to 24 hours
Using computational methods, the PRx was determined by calculating the correlation coefficient between 20 consecutive, time-averaged data points (60-second periods) of ICP and Arterial Blood Pressure (ABP). A positive PRx correlation suggests impaired cerebrovascular pressure reactivity, that is, passive transmission of changes in ABP to ICP. A negative PRx correlation indicates good pressure reactivity. Any change in ABP produces inverse changes in ICP.
3 secondary outcomes
Amount of Sedative/Analgesic Used During Treatment in Patients With Secondary Brain Injury
Time frame: 24 hours
Cerebral Perfusion Pressure Changes in Patients With Secondary Brain Injury
Time frame: Baseline to 24 hours
Mean Arterial Blood Pressure (MAP) Variability in Patients With Secondary Brain Injury
Time frame: Baseline to 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24506248Lazaridis C, DeSantis SM, Smielewski P, Menon DK, Hutchinson P, Pickard JD, Czosnyka M. Patient-specific thresholds of intracranial pressure in severe traumatic brain injury. J Neurosurg. 2014 Apr;120(4):893-900. doi: 10.3171/2014.1.JNS131292. Epub 2014 Feb 7.
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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.
Keith Dombrowski, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Standard-of-Care plus Dexmedetomidine and Standard-of-Care in people with Endotracheal Intubation and Continuous IV Sedation, run by Duke University at 1 site 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 2 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 2 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Variability of Intracranial Pressure (ICP) (time frame: Baseline to 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01169467, which also lists 1 linked publication.
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 2 Nov 2015.