Blood Pressure Treatment in ICU Patients With Subarachniodal Haemorrhage. (BFBP)
Primary Purpose
Blood Pressure, Subarachnoid Hemorrhage, Aneurysm Cerebral
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Blood pressure elevation
Sponsored by
About this trial
This is an interventional basic science trial for Blood Pressure focused on measuring magnetic resonance imaging, norepinephrine, blood flow
Eligibility Criteria
Inclusion Criteria: Coiled or clipped aneurysm Suspected or confirmed vasospasm Exclusion Criteria: BMI >30 Pregnancy Pacemaker or other MRI contraindications Severe congestive heart failure (NYHA III-IV) or cardiac arrhythmia. Severe respiratory failure or FiO2 >0.6 Severe kidney failure
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cerebral blood flow
Arm Description
Change in cerebral blood flow with increased systemic blood pressure
Outcomes
Primary Outcome Measures
Cerebral blood flow
mL/min as measured by MRI
Secondary Outcome Measures
Full Information
NCT ID
NCT06033378
First Posted
September 4, 2023
Last Updated
September 4, 2023
Sponsor
Umeå University
Collaborators
Region Västerbotten
1. Study Identification
Unique Protocol Identification Number
NCT06033378
Brief Title
Blood Pressure Treatment in ICU Patients With Subarachniodal Haemorrhage.
Acronym
BFBP
Official Title
Blood Pressure Treatment in ICU Patients With Subarachniodal Haemorrhage. -Can Blood Pressure be Used as a Surrogate Marker for Blood Flow
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Umeå University
Collaborators
Region Västerbotten
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
An MRI study to examine the relationship between blood pressure and cerebral blood flow in patients with subarachnoidal hemorrhage and suspect or verified vasospasm.
Detailed Description
Subarachnoidal hemorrhage (SAH) is a type of stroke with high mortality rates and often requires care at the intensive care unit. Cerebral blood flow (CBF) needs to be ensured so that the brain receives optimal nourishment, and this is largely controlled by regulating blood pressure (BP) using medications that affect the heart and blood vessels. Approximately 3-7 days after SAH onset, vasospasm (SAH-V) can occur. Treatment usually includes maintaining blood pressure (BP) above a certain threshold to achieve adequate cerebral blood flow (CBF). An important component of raising BP is increasing vascular resistance using vasoconstrictive medications, which paradoxically can decrease CBF.
Our objective is to investigate the correlation between BP changes and their impact on CBF in patients with suspect or verified SAH-V using MRO.
To achieve our purpose, we plan to examine the relationship between BP and CBF in patients with SAH-V who require neuro-intensive care. For measuring CBF, we will use MRI with two different MRI techniques: phase-contrast MRI and arterial spin labeling.
Flow measurement with MRI:
Baseline images will be acquired at baseline blood pressure.
Mean arterial pressure (MAP) will be increased using norepinephrine. New images will be acquired when MAP is increased by approximately 20-30% from the baseline.
All BP levels will be maintained within clinically acceptable ranges. All data will be recorded in the patient's medical record, and MRI images will be processed at a later stage.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, Subarachnoid Hemorrhage, Aneurysm Cerebral
Keywords
magnetic resonance imaging, norepinephrine, blood flow
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cerebral blood flow
Arm Type
Experimental
Arm Description
Change in cerebral blood flow with increased systemic blood pressure
Intervention Type
Other
Intervention Name(s)
Blood pressure elevation
Intervention Description
Increasing systemic blood pressure for measurement of cerebral blood flow changes
Primary Outcome Measure Information:
Title
Cerebral blood flow
Description
mL/min as measured by MRI
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Coiled or clipped aneurysm Suspected or confirmed vasospasm
Exclusion Criteria:
BMI >30 Pregnancy Pacemaker or other MRI contraindications Severe congestive heart failure (NYHA III-IV) or cardiac arrhythmia. Severe respiratory failure or FiO2 >0.6 Severe kidney failure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laleh Zarrinkoob, MD, PhD
Phone
+46707567067
Email
laleh.zarrinkoob@umu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laleh Zarrinkoob
Organizational Affiliation
Region Västerbotten
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Blood Pressure Treatment in ICU Patients With Subarachniodal Haemorrhage.
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