Cerebral Perfusion PressurePhase 4NCT02744625
Physiologic Study of Cerebral Perfusion
A Phase 4 study testing Higher doses of vasopressor therapy for a MAP of 75 mmHg, Lower doses of vasopressor therapy for a MAP of 65 mmHg and Propofol for light sedation in people with Cerebral Perfusion Pressure and Vasopressor Agents, run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke at 1 site in Canada.
Trial summary
The aim of the study is to measure cerebral perfusion using MRI in healthy subjects (with and without sedation) and in vasopressor-dependent patients Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebral Perfusion Pressure, Vasopressor Agents, Shock
- What is being tested?
- Higher doses of vasopressor therapy for a MAP of 75 mmHg, Lower doses of vasopressor therapy for a MAP of 65 mmHg and Propofol for light sedation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2016to Mar 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- being over 18 years old
- being over 18 years old
- being hospitalized to the medical intensive care unit of the CHUS Fleurimont
- being in a stabilized shock state, primarily of distributive etiology
- having received an appropriate fluid resuscitation, as judged by the attending physician
Who cannot join
- having a positive serum pregnancy test
- having a contraindication to MRI
- having a contraindication to receive light sedation with propofol
- suffering of claustrophobia or of anxiety disorder
- Shock Subjects :
- having a different primary etiology of shock than distributive (cardiogenic, hypovolemic, obstructive)
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- needing vasopressor therapy as the result of extracorporeal circulation
- having known cerebral lesions
- having an intra-aortic balloon pump
- being in a palliative or near end-of-life situation
- having a contraindication to MRI
- suffering of claustrophobia or of anxiety disorder
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to measure cerebral perfusion using MRI in healthy subjects (with and without sedation) and in vasopressor-dependent patients
- Conditions
- Cerebral Perfusion Pressure, Vasopressor Agents, Shock, Magnetic Resonance Imaging (MRI), Functional
- Being tested
- Higher doses of vasopressor therapy for a MAP of 75 mmHg, Lower doses of vasopressor therapy for a MAP of 65 mmHg, Propofol for light sedation
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Higher doses of vasopressor therapy for a MAP of 75 mmHgDrug
Lower doses of vasopressor therapy for a MAP of 65 mmHgDrug
Propofol for light sedationDrug
Propofol for light sedation
| Study group | Role | What they receive |
|---|---|---|
| Shock lower Mean Arterial Pressure (MAP) | Active comparator | Vasopressor-dependent treated to lower MAP (65 mmHg) Receives: Drug: Lower doses of vasopressor therapy for a MAP of 65 mmHg; Drug: Propofol for light sedation |
| Shock higher MAP | Experimental | Vasopressor-dependent treated to higher MAP (75 mmHg) Receives: Drug: Higher doses of vasopressor therapy for a MAP of 75 mmHg; Drug: Propofol for light sedation |
| Healthy participant awake | No intervention | Healthy participant awake |
| Healthy participant sedated | Experimental | Healthy participant Under light sedation Receives: Drug: Propofol for light sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global and regional cerebral blood flow
Cerebral blood flow will be measured by the arterial spin labeling technique (ASL) which provides information expressed in mL/100g/min. Using 3-T MRI technology,we will first acquire T1 images of the brain and sub-regions of interest. Thereafter, ASL sequences will be acquired in contiguous slices. The procedure will be followed on sedation and off sedation for healthy volunteers (in random order) and at mean arterial pressure of 65 mmHg and 75 mmHg (in random order) in patients receiving vasopressor therapy.
Measured: Within 15 minutes of intervention initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Perfusion PressureStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, François Lamontagne, Université de Sherbrooke
- Investigators
- François Lamontagne, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744625
- Sponsor's protocol ID
- 2016-1267
- Status last verified
- Mar 2017
- First submitted
- 7 Apr 2016
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologic Study of Cerebral Perfusion
- ClinicalTrials.gov ID
- NCT02744625
- Acronym / sponsor ID
- 2016-1267
- Conditions
- Cerebral Perfusion Pressure, Vasopressor Agents, Shock, Magnetic Resonance Imaging (MRI), Functional
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Centre de recherche du Centre hospitalier universitaire de SherbrookeUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 20 Apr 2016 (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 aim of the study is to measure cerebral perfusion using MRI in healthy subjects (with and without sedation) and in vasopressor-dependent patients
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Shock lower Mean Arterial Pressure (MAP) | Active comparator | Drug: Lower doses of vasopressor therapy for a MAP of 65 mmHg, Drug: Propofol for light sedationVasopressor-dependent treated to lower MAP (65 mmHg) |
| Shock higher MAP | Experimental | Drug: Higher doses of vasopressor therapy for a MAP of 75 mmHg, Drug: Propofol for light sedationVasopressor-dependent treated to higher MAP (75 mmHg) |
| Healthy participant awake | No intervention | –Healthy participant awake |
| Healthy participant sedated | Experimental | Drug: Propofol for light sedationHealthy participant Under light sedation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
Key exclusion criteria (12 listed)
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 |
|---|---|---|
| Higher doses of vasopressor therapy for a MAP of 75 mmHg | Drug | Shock higher MAP |
| Lower doses of vasopressor therapy for a MAP of 65 mmHg | Drug | Shock lower Mean Arterial Pressure (MAP) |
| Propofol for light sedationPropofol for light sedation | Drug | Healthy participant sedated, Shock higher MAP, Shock lower Mean Arterial Pressure (MAP) |
Primary outcome
Global and regional cerebral blood flow
Time frame: Within 15 minutes of intervention initiation
Cerebral blood flow will be measured by the arterial spin labeling technique (ASL) which provides information expressed in mL/100g/min. Using 3-T MRI technology,we will first acquire T1 images of the brain and sub-regions of interest. Thereafter, ASL sequences will be acquired in contiguous slices. The procedure will be followed on sedation and off sedation for healthy volunteers (in random order) and at mean arterial pressure of 65 mmHg and 75 mmHg (in random order) in patients receiving vasopressor therapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
- Individual participant dataSharing planned: Undecided
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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.
François Lamontagne principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Higher doses of vasopressor therapy for a MAP of 75 mmHg, Lower doses of vasopressor therapy for a MAP of 65 mmHg and Propofol for light sedation in people with Cerebral Perfusion Pressure and Vasopressor Agents, run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke at 1 site in Canada.
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 5 inclusion and 12 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 30 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 1 site in Canada. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Global and regional cerebral blood flow (time frame: Within 15 minutes of intervention initiation). 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 30 Mar 2017.