Physiologic Study of Cerebral Perfusion

March 28, 2017 updated by: François Lamontagne, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Université de Sherbrooke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Healthy Subjects :

  • Inclusion criteria :

    • being over 18 years old

  • Exclusion criterias :

    • 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 :

  • Inclusion criterias :

    • 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 criterias :

    • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Shock lower Mean Arterial Pressure (MAP)
Vasopressor-dependent treated to lower MAP (65 mmHg)
Drug: Lower doses of vasopressor therapy for a MAP of 65 mmHg
Drug: Propofol for light sedation
Propofol for light sedation
Experimental: Shock higher MAP
Vasopressor-dependent treated to higher MAP (75 mmHg)
Drug: Propofol for light sedation
Propofol for light sedation
Drug: Higher doses of vasopressor therapy for a MAP of 75 mmHg
No Intervention: Healthy participant awake
Experimental: Healthy participant sedated
Healthy participant Under light sedation
Drug: Propofol for light sedation
Propofol for light sedation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 15 minutes of intervention initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Investigators

  • Principal Investigator: François Lamontagne, Université de Sherbrooke

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

April 7, 2016

First Submitted That Met QC Criteria

April 15, 2016

First Posted (Estimate)

April 20, 2016

Study Record Updates

Last Update Posted (Actual)

March 30, 2017

Last Update Submitted That Met QC Criteria

March 28, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-1267

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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