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| Name | Class |
|---|---|
| MaineHealth | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metoprolol (Beta-adrenergic blockade) | Experimental | Patients will receive metoprolol during the first 72-hours of hospitalization after non-traumatic SAH. |
|
| Placebo | Placebo Comparator | Patients will receive placebo during the first 72-hours of hospitalization after non-traumatic SAH. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metoprolol | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Delta QTc length | Change (Delta) QTc length between intervention and control groups. | 7 days |
| Delta neutrophil activity | Delta neutrophil activity between intervention and control groups. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Including but not limited to symptomatic bradycardia, symptomatic hypotension, or complete heart block | 7-days |
| Number of patients with evidence of cardiac injury | Measurement of troponin levels, echocardiograph |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Madeleine Puissant, MD, PhD | Contact | 2076613660 | Madeleine.Puissant@mainehealth.org | |
| Christine Lord | Contact | Christine.Lord@mainehealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Madeleine Puissant, MD, PhD | MaineHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MaineHealth | Recruiting | Portland | Maine | 04012 | United States |
De-identified data will be shared.
At study completion and until 6-months post-publication.
A de-identified data set will be made available and people may request access to this.
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008790 | Metoprolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| Placebo | Drug | 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 |
|
| 7-days |
| Need for Vasopressors | Any documented intravenous vasoactive medication administration | 7-days |
| Sympathetic Nervous System (SNS) Activity | Catecholamine Measurements | 7-days |
| Neutrophil Activity | Measurement of neutrophils in CSF and serum samples | 7 days |
| Evidence of Clinical Vasospasm | Evidence of clinical vasospasm | Up to 15-weeks |
| ICU Length of Stay (LOS) | Number of full days | Up to 15-weeks |
| Hospital Length of Stay (LOS) | Number of full days | Up to 15-weeks |
| In-hospital mortality | Whether patient died during during sentinel hospitalization | Up to 15-weeks |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |