Brain InjuryPhase 1/2PrePARENCT00538616
Precedex Versus Propofol-Awakening for Reducing Brain Injury Expansion
A Phase 1/2 study testing Dexmedetomidine and Propofol in people with Brain Injury and Intracranial Pressure, run by Carmelo Graffagnino at 1 site in United States.
Trial summary
The purpose of this study is to evaluate brain injury when two different drugs (propofol and precedex) are used to sedate patients who need a neurologic exam. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injury, Intracranial Pressure
- What is being tested?
- Dexmedetomidine and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Apr 2010
- Phase
- Phase 1/2
- 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
- primary diagnosis of Traumatic Brain Injury (TBI), Subarachnoid Hemorrhage (SAH),Intracranial Hemorrhage (ICH), stroke
- Must require (be on) mechanical ventilation
- must require (have in place) intracranial pressure (ICP) monitoring
- must require (be receiving) continuous IV sedation
Who cannot join
- Bleeding diathesis
- Glasgow Coma Scale (GCS) < 5 with fixed pupils
- Pregnant
- elevated ICP that requires deep sedation
- pulmonary instability
- Hx of Ethanol(ETOH) abuse that requires current benzodiazepine treatment for delirium - allergy to propofol or precedex
- status epilepticus
- current neuromuscular blockade
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IV Single Center Cross Over Clinical Study Comparing Two Different Sedations Strategies for Mechanically Ventilated Patients With Neurological Critical Illness
The purpose of this study is to evaluate brain injury when two different drugs (propofol and precedex) are used to sedate patients who need a neurologic exam.
Read the detailed description
The hypothesis is that a neurologic exam performed when the subject has continuous infusion of precedex will result in less brain injury (where the lactate/pyruvate ratio indicates injury) then when a neurologic exam is performed on subjects receiving propofol, because that exam requires that the propofol infusion be stopped.
- Conditions
- Brain Injury, Intracranial Pressure
- Being tested
- Dexmedetomidine, Propofol
- Keywords
- Brain Injury
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)
PropofolDrug
Also called Diprivan
in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)
| Study group | Role | What they receive |
|---|---|---|
| Precedex-Propofol | Active comparator | Patients received an infusion of precedex for six hours and then a washout and then a propofol infusion for six hours. Receives: Drug: Dexmedetomidine; Drug: Propofol |
| Propofol- Precedex | Active comparator | Patients received an infusion of propofol for six hours and then a washout and then a precedex infusion for six hours. Receives: Drug: Dexmedetomidine; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactate/Pyruvate (L/P)Ratio
L/P ratio was measured before during and after sedation assessment. The micromole value for each dialysate (lactate and pyruvate) was reported as well as the ratio (L/P). Elevated ratios (greater than 30) were attributed to metabolic distress (relative hypoxemia)during the course of the trial.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2007 (estimated)
- Study startJan 2008
- Primary completionFeb 2008
- Study completionApr 2010
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.
- Other trials for Brain InjuryStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmelo Graffagnino
- Sponsor type
- University, hospital or other
- Collaborators
- Hospira, now a wholly owned subsidiary of Pfizer
- Responsible party
- Sponsor-investigator, Carmelo Graffagnino, Duke University
- Investigators
- Carmelo Graffagnino, MD, Principal investigator, Duke UniversityDaiWai M Olson, PhD RN, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00538616
- Sponsor's protocol ID
- Pro00002077
- Acronym
- PrePARE
- Status last verified
- Mar 2013
- First submitted
- 28 Sep 2007
- Last updated
- 11 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Single Center Cross Over Clinical Study Comparing Two Different Sedations Strategies for Mechanically Ventilated Patients With Neurological Critical Illness
- ClinicalTrials.gov ID
- NCT00538616
- Acronym / sponsor ID
- PrePARE / Pro00002077
- Conditions
- Brain Injury, Intracranial Pressure
- Keywords
- Brain Injury
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Carmelo GraffagninoUniversity, hospital or other
- Collaborators
- Hospira, now a wholly owned subsidiary of Pfizer
- Study start
- Jan 2008
- Primary completion
- Feb 2008 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 2 Oct 2007 (estimated)
- Results
- Posted 11 Apr 2013
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 brain injury when two different drugs (propofol and precedex) are used to sedate patients who need a neurologic exam.
Detailed description
The hypothesis is that a neurologic exam performed when the subject has continuous infusion of precedex will result in less brain injury (where the lactate/pyruvate ratio indicates injury) then when a neurologic exam is performed on subjects receiving propofol, because that exam requires that the propofol infusion be stopped.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Precedex-Propofol | Active comparator | Drug: Dexmedetomidine, Drug: PropofolPatients received an infusion of precedex for six hours and then a washout and then a propofol infusion for six hours. |
| Propofol- Precedex | Active comparator | Drug: Dexmedetomidine, Drug: PropofolPatients received an infusion of propofol for six hours and then a washout and then a precedex infusion for six hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- primary diagnosis of Traumatic Brain Injury (TBI), Subarachnoid Hemorrhage (SAH),Intracranial Hemorrhage (ICH), stroke
- Must require (be on) mechanical ventilation
- must require (have in place) intracranial pressure (ICP) monitoring
- must require (be receiving) continuous IV sedation
Key exclusion criteria (8 listed)
- Bleeding diathesis
- Glasgow Coma Scale (GCS) < 5 with fixed pupils
- Pregnant
- elevated ICP that requires deep sedation
- pulmonary instability
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: Precedexin this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover) | Drug | Precedex-Propofol, Propofol- Precedex |
| PropofolAlso: Diprivanin this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover) | Drug | Precedex-Propofol, Propofol- Precedex |
Primary outcome
Lactate/Pyruvate (L/P)Ratio
Time frame: 1 hour
L/P ratio was measured before during and after sedation assessment. The micromole value for each dialysate (lactate and pyruvate) was reported as well as the ratio (L/P). Elevated ratios (greater than 30) were attributed to metabolic distress (relative hypoxemia)during the course of the trial.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Carmelo Graffagnino, MD principal investigator
Duke University
DaiWai M Olson, PhD RN 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 1/2 study testing Dexmedetomidine and Propofol in people with Brain Injury and Intracranial Pressure, run by Carmelo Graffagnino 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 8 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 11 Apr 2013. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 11 Apr 2013). 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?
Lactate/Pyruvate (L/P)Ratio (time frame: 1 hour). 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 11 Apr 2013.