BFBP: Blood Pressure Treatment in ICU Patients With Subarachniodal Haemorrhage.

Sponsor
Umeå University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06033378
Collaborator
Region Västerbotten (Other)
30
1
24

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Blood pressure elevation
N/A

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:
  1. Baseline images will be acquired at baseline blood pressure.

  2. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Blood Pressure Treatment in ICU Patients With Subarachniodal Haemorrhage. -Can Blood Pressure be Used as a Surrogate Marker for Blood Flow
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2025
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cerebral blood flow

Change in cerebral blood flow with increased systemic blood pressure

Other: Blood pressure elevation
Increasing systemic blood pressure for measurement of cerebral blood flow changes

Outcome Measures

Primary Outcome Measures

  1. Cerebral blood flow [1 hour]

    mL/min as measured by MRI

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Umeå University
  • Region Västerbotten

Investigators

  • Principal Investigator: Laleh Zarrinkoob, Region Västerbotten

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Umeå University
ClinicalTrials.gov Identifier:
NCT06033378
Other Study ID Numbers:
  • 2022-06754-01
First Posted:
Sep 13, 2023
Last Update Posted:
Sep 13, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Umeå University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 13, 2023