Physiologic Study of Cerebral Perfusion

Shock Clinical Trial

Official title:

Physiologic Study of Cerebral Perfusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02744625
• Other study ID #: 2016-1267
• Status: Completed
• Phase: Phase 4
• First received: April 7, 2016
• Last updated: March 28, 2017
• Start date: April 2016
• Est. completion date: March 2017

Study information

• Verified date: March 2017
• Source: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

• Lower doses of vasopressor therapy for a MAP of 65 mmHg

• Propofol for light sedation
Propofol for light sedation

Locations

Country	Name	City	State
Canada	Université de Sherbrooke	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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