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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
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Blood Pressure focused on measuring magnetic resonance imaging, norepinephrine, blood flow

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 4, 2023
    Last Updated
    September 4, 2023
    Sponsor
    Umeå University
    Collaborators
    Region Västerbotten
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    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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