To determine the effect of early metoprolol administration after non-traumatic subarachnoid hemorrhage (SAH).
To determine the effect of early metoprolol administration after non-traumatic subarachnoid hemorrhage (SAH) on the brain and cardiac tissue damage and inflammation, we will conduct a pilot randomized controlled trial comparing (1) sympathetic nervous system (SNS) activation, (2) cardiac rhythm abnormalities, (3) biomarkers of brain and cardiac tissue damage, and (4) and neutrophil activity in patients receiving metoprolol (n=10) or placebo (n=10) for the first 72-hours after SAH.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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
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
MaineHealth
Portland, Maine, United States
RECRUITINGDelta QTc length
Change (Delta) QTc length between intervention and control groups.
Time frame: 7 days
Delta neutrophil activity
Delta neutrophil activity between intervention and control groups.
Time frame: 7 days
Adverse events
Including but not limited to symptomatic bradycardia, symptomatic hypotension, or complete heart block
Time frame: 7-days
Number of patients with evidence of cardiac injury
Measurement of troponin levels, echocardiograph
Time frame: 7-days
Need for Vasopressors
Any documented intravenous vasoactive medication administration
Time frame: 7-days
Sympathetic Nervous System (SNS) Activity
Catecholamine Measurements
Time frame: 7-days
Neutrophil Activity
Measurement of neutrophils in CSF and serum samples
Time frame: 7 days
Evidence of Clinical Vasospasm
Evidence of clinical vasospasm
Time frame: Up to 15-weeks
ICU Length of Stay (LOS)
Number of full days
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Time frame: Up to 15-weeks
Hospital Length of Stay (LOS)
Number of full days
Time frame: Up to 15-weeks
In-hospital mortality
Whether patient died during during sentinel hospitalization
Time frame: Up to 15-weeks