Blood Pressure Treatment in ICU Patients with Subarachniodal Haemorrhage.

NCT ID: NCT06033378

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2028-09-01

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.

The study objective is to investigate the correlation between BP changes and their impact on CBF in patients with suspect or verified SAH-V using MRI.

To achieve this purpose, the investigators plan to examine the relationship between BP and CBF in patients with SAH-V who require neuro-intensive care. To measure CBF, two techniquis will be used: 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.

Conditions

Blood Pressure; Subarachnoid Hemorrhage; Aneurysm Cerebral

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Cerebral blood flow

Change in cerebral blood flow with increased systemic blood pressure

Group Type: EXPERIMENTAL

Blood pressure elevation

Intervention Type: OTHER

Increasing systemic blood pressure for measurement of cerebral blood flow changes

Interventions

Blood pressure elevation

Increasing systemic blood pressure for measurement of cerebral blood flow changes

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Västerbotten

OTHER_GOV

Sponsor Role: collaborator

Umeå University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laleh Zarrinkoob

Role: PRINCIPAL_INVESTIGATOR

Region Västerbotten

Locations

Umeå University Hospital

Umeå, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Laleh Zarrinkoob, MD, PhD

Role: CONTACT

laleh.zarrinkoob@umu.se

+46707567067

Facility Contacts

Laleh Zarrinkoob, MD, PhD

Role: primary

laleh.zarrinkoob@umu.se

+46707567067

Other Identifiers

2022-06754-01

Identifier Type: -

Identifier Source: org_study_id