Physiologic Study of Cerebral Perfusion

NCT ID: NCT02744625

Last Updated: 2017-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-03-31

Brief Summary

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The aim of the study is to measure cerebral perfusion using MRI in healthy subjects (with and without sedation) and in vasopressor-dependent patients

Detailed Description

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Conditions

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Cerebral Perfusion Pressure Vasopressor Agents Shock Magnetic Resonance Imaging (MRI), Functional

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Shock lower Mean Arterial Pressure (MAP)

Vasopressor-dependent treated to lower MAP (65 mmHg)

Group Type ACTIVE_COMPARATOR

Lower doses of vasopressor therapy for a MAP of 65 mmHg

Intervention Type DRUG

Propofol for light sedation

Intervention Type DRUG

Propofol for light sedation

Shock higher MAP

Vasopressor-dependent treated to higher MAP (75 mmHg)

Group Type EXPERIMENTAL

Higher doses of vasopressor therapy for a MAP of 75 mmHg

Intervention Type DRUG

Propofol for light sedation

Intervention Type DRUG

Propofol for light sedation

Healthy participant awake

Healthy participant awake

Group Type NO_INTERVENTION

No interventions assigned to this group

Healthy participant sedated

Healthy participant Under light sedation

Group Type EXPERIMENTAL

Propofol for light sedation

Intervention Type DRUG

Propofol for light sedation

Interventions

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Higher doses of vasopressor therapy for a MAP of 75 mmHg

Intervention Type DRUG

Lower doses of vasopressor therapy for a MAP of 65 mmHg

Intervention Type DRUG

Propofol for light sedation

Propofol for light sedation

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre de recherche du Centre hospitalier universitaire de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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François Lamontagne

Clinician Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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François Lamontagne

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Locations

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Université de Sherbrooke

Sherbrooke, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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2016-1267

Identifier Type: -

Identifier Source: org_study_id

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