Post-operative Atrial Fibrillation
Conditions
Keywords
Metoprolol, Genotype, Phenotype, CYP2D6
Brief summary
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.
Interventions
OTHERGuided Metoprolol Management
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.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single Group Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age greater than or equal to 18 years * Scheduled for surgical procedure (coronary artery bypass graft and/or valve repair/replacement) at Vanderbilt University Medical Center
Exclusion criteria
* History of allergic reactions or contraindications to beta-blockers * Patients with persistent atrial fibrillation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of post-operative atrial fibrillation | From the end of anesthesia up to hospital discharge; usually 3-4 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | From end of surgery to hospital discharge; usually 3-4 days | Length of hospital stay (in days) after surgery |
| 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 | — |
| Rate of genome tailored prescription changes | From the end of anesthesia up to hospital discharge; usually 3-4 days | Rate of genome tailored prescription changes as measured by the proportion of patients in whom metoprolol prescription is based on CYP2D6 metabolizer status. |
| 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 | From end of anesthesia to hospital discharge; usually 3-4 days | Reasons for non-adherence to recommendations; prepopulated choices including 1. clinically inappropriate recommendation 2. provider preference 3. Other (free text option). |
| Incidence of adverse drug events | From end of anesthesia to hospital discharge; usually 3-4 days | — |
Countries
United States
Outcome results
None listed