Physiologic Study of Cerebral Perfusion

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Status and phase: Completed; Phase 4

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

Treatments: Drug: Lower doses of vasopressor therapy for a MAP of 65 mmHg; Drug: Higher doses of vasopressor therapy for a MAP of 75 mmHg; Drug: Propofol for light sedation

Study type: Interventional

Funder types: Other

Identifiers

NCT02744625

2016-1267

Details and patient eligibility

About

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

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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22 participants in 4 patient groups

Shock lower Mean Arterial Pressure (MAP)

Active Comparator group

Description:

Vasopressor-dependent treated to lower MAP (65 mmHg)

Treatment:

Drug: Propofol for light sedation

Drug: Lower doses of vasopressor therapy for a MAP of 65 mmHg

Shock higher MAP

Experimental group

Description:

Vasopressor-dependent treated to higher MAP (75 mmHg)

Treatment:

Drug: Higher doses of vasopressor therapy for a MAP of 75 mmHg

Drug: Propofol for light sedation

Healthy participant awake

No Intervention group

Description:

Healthy participant awake

Healthy participant sedated

Experimental group

Description:

Healthy participant Under light sedation

Treatment:

Drug: Propofol for light sedation