RecruitingPhase 4NCT06569212

Beta-1 Adrenergic Inhibition to Reduce Cardiac Injury and Inflammation After Subarachnoid Hemorrhage (BADCATS)


Sponsor

Madeleine Puissant

Enrollment

20 participants

Start Date

Sep 23, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To determine the effect of early metoprolol administration after non-traumatic subarachnoid hemorrhage (SAH).


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • >18 years of age
  • Neuro-imaging confirmed non-traumatic subarachnoid hemorrhage

Exclusion Criteria10

  • Traumatic cause of subarachnoid hemorrhage (e.g. fall, motor vehicle accident, other blunt trauma) as this is a different mechanism of hemorrhage.
  • Other forms of traumatic or non-traumatic intracranial bleed including intracerebral hemorrhage (ICH), subdural hemorrhage, epidural hemorrhage
  • Pregnancy (as the study medication, metoprolol, has FDA Pregnancy Category C rating)
  • Unstable vital signs not amenable to beta-1 adrenergic receptor inhibitor (B1ARi) administration including:
  • Systolic blood pressure < 80 mmHg not stabilized on vasopressor medications
  • Heart rate < 50 bpm associated with hypotension
  • Patients requiring vasopressor agents due to hypotension (SBP <80 mmHg)
  • Other vital sign exclusion at the discretion of the treatment team
  • Previous history of severe heart failure (Stage C or D Heart Failure and/or NYHA Class III or IV)
  • Patient or legally authorized representative unwilling to provide informed consent

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Interventions

DRUGMetoprolol

Metoprolol Dosing: Metoprolol Injection (instructions: 5mg, once) Metoprolol Tab (25mg PO, q12 hours, timed to start 1hr after Metoprolol Injection, 6 doses) If unable to take PO medication, Metoprolol Injection (instructions, 5mg q6hrs for 12 doses) Continue for 72-hours of administration unless reaching stopping criteria

DRUGPlacebo

Placebo Dosing: Placebo Injection (instructions: 5mL NS, once) Placebo Tab (1 tab PO, q12 hours, timed to start 1hr after placebo injection, 6 doses) If unable to take PO medication, Placebo Injection (instructions, 5mL q6hrs for 12 doses) Continue for 72-hours of administration unless reaching stopping criteria


Locations(1)

MaineHealth

Portland, Maine, United States

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NCT06569212