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Metoprolol is frequently administered to cardiac surgery patients to reduce the incidence of postoperative atrial fibrillation (PoAF). Metoprolol is metabolized by the enzyme CYP2D6, which is known to have many mutations that could influence a patient's ability to metabolize the drug. In this prospective clinical trial, the investigators will determine the genotype of CYP2D6 for patients undergoing cardiac surgery, provide an altered dosing recommendation for metoprolol, then report the relative effectiveness in managing PoAF for each pharmacogenetic- guided dosing category. The investigators will also explore the effects of personalized metoprolol dosing recommendations on outcomes in hospital length of stay, cost, and provider participation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacogenetic-guided metoprolol management | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guided Metoprolol Management | Other | CYP2D6 Genotyping: Consented patients will have blood drawn for genotyping prior to surgery. Patients will be classified as poor metabolizers, intermediate metabolizers, extensive (normal) metabolizers, or ultrafast metabolizers. Pharmacogenetic- Guided Metoprolol Management: A best practice advisory will be integrated into institutional clinical decision support systems for metoprolol dosing based on metabolic status of each patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of post-operative atrial fibrillation | Incidence of post-operative atrial fibrillation measured with post-operative electrocardiogram or rhythm strip, or at least two of the following: documentation in the progress notes, nursing notes, discharge summary, and change in medication. | From the end of anesthesia up to hospital discharge; usually 3-4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of genome tailored prescription changes | Rate of genome tailored prescription changes as measured by the proportion of patients in whom metoprolol prescription is based on CYP2D6 metabolizer status. | From the end of anesthesia up to hospital discharge; usually 3-4 days |
| Length of hospital stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miklos Kertai, MD. PhD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37407326 | Derived | Staben R, Vnencak-Jones CL, Shi Y, Shotwell MS, Absi T, Shah AS, Wanderer JP, Beller M, Kertai MD. Preemptive Pharmacogenetic-Guided Metoprolol Management for Postoperative Atrial Fibrillation in Cardiac Surgery: The Preemptive Pharmacogenetic-Guided Metoprolol Management for Atrial Fibrillation in Cardiac Surgery Pilot Trial. J Cardiothorac Vasc Anesth. 2023 Oct;37(10):1974-1982. doi: 10.1053/j.jvca.2023.06.017. Epub 2023 Jun 14. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 25, 2019 | Mar 7, 2023 | ICF_000.pdf |
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Single Group Assignment
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|
Length of hospital stay (in days) after surgery |
| From end of surgery to hospital discharge; usually 3-4 days |
| Overall cost of treatment | From end of surgery to hospital discharge; usually 3-4 days |
| Cost of interventions to control or treat post-operative atrial fibrillation | From end of anesthesia to hospital discharge; usually 3-4 days |
| Incidence of adverse drug events | From end of anesthesia to hospital discharge; usually 3-4 days |
| Proportion of clinical decision support tool recommendations that were acknowledged and accepted by provider | From end of anesthesia to hospital discharge; usually 3-4 days |
| Proportion of clinical decision support tool recommendations that were acknowledged but ignored by the provider. | From end of anesthesia to hospital discharge; usually 3-4 days |
| Reasons for non-adherence to recommendations | Reasons for non-adherence to recommendations; prepopulated choices including 1. clinically inappropriate recommendation 2. provider preference 3. Other (free text option). | From end of anesthesia to hospital discharge; usually 3-4 days |