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Completed

NCT Number: NCT02744625

Physiologic Study of Cerebral Perfusion

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

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Key information

Conditions

Cerebral Perfusion Pressure Magnetic Resonance Imaging (MRI), Functional Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Vasopressor Agents

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Université de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Higher doses of vasopressor therapy for a MAP of 75 mmHg

Drug

Lower doses of vasopressor therapy for a MAP of 65 mmHg

Drug

Propofol for light sedation

Drug

Propofol for light sedation

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 20, 2016
Registry last updated
Mar 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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