NCT02744625

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 30, 2017

Status Verified

March 1, 2017

Enrollment Period

11 months

First QC Date

April 7, 2016

Last Update Submit

March 28, 2017

Conditions

Cerebral Perfusion PressureVasopressor AgentsShockMagnetic Resonance Imaging (MRI), Functional

Outcome Measures

Primary Outcomes (1)

  • 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.

    Within 15 minutes of intervention initiation

Study Arms (4)

Shock lower Mean Arterial Pressure (MAP)

ACTIVE COMPARATOR

Vasopressor-dependent treated to lower MAP (65 mmHg)

Drug: Lower doses of vasopressor therapy for a MAP of 65 mmHgDrug: Propofol for light sedation

Shock higher MAP

EXPERIMENTAL

Vasopressor-dependent treated to higher MAP (75 mmHg)

Drug: Higher doses of vasopressor therapy for a MAP of 75 mmHgDrug: Propofol for light sedation

Healthy participant awake

NO INTERVENTION

Healthy participant awake

Healthy participant sedated

EXPERIMENTAL

Healthy participant Under light sedation

Drug: Propofol for light sedation

Interventions

Higher doses of vasopressor therapy for a MAP of 75 mmHgDRUG
Shock higher MAP
Lower doses of vasopressor therapy for a MAP of 65 mmHgDRUG
Shock lower Mean Arterial Pressure (MAP)
Propofol for light sedationDRUG

Propofol for light sedation

Healthy participant sedatedShock higher MAPShock lower Mean Arterial Pressure (MAP)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • being over 18 years old

You may not qualify if:

  • 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 :
  • 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
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Shock

Interventions

Propofol

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • François Lamontagne

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinician Scientist

Study Record Dates

First Submitted

April 7, 2016

First Posted

April 20, 2016

Study Start

April 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

March 30, 2017

Record last verified: 2017-03

Locations

CA(1)