Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
Completed
NCT Number: NCT03943927
Preemptive Pharmacogenetic-guided Metoprolol Management for PostoperativeAtrial Fibrillation in Cardiac Surgery
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.
Completed
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Guided Metoprolol Management
OtherCYP2D6 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.
Primary outcomes
-
Incidence of post-operative atrial fibrillation
Time frame: 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 outcomes
-
Rate of genome tailored prescription changes
Time frame: 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.
-
Length of hospital stay
Time frame: From end of surgery to hospital discharge; usually 3-4 days
Length of hospital stay (in days) after surgery
-
Overall cost of treatment
Time frame: From end of surgery to hospital discharge; usually 3-4 days
-
Cost of interventions to control or treat post-operative atrial fibrillation
Time frame: From end of anesthesia to hospital discharge; usually 3-4 days
-
Incidence of adverse drug events
Time frame: 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
Time frame: 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.
Time frame: From end of anesthesia to hospital discharge; usually 3-4 days
-
Reasons for non-adherence to recommendations
Time frame: 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).
Sponsors and collaborators
Lead sponsor
Vanderbilt University Medical Center
Other
Registry information
Official study title
Preemptive Pharmacogenetic- Guided Metoprolol Management for Postoperative Atrial Fibrillation in Cardiac Surgery: The PREEMPTIVE- Pilot Trial
Acronym: PREEMPTIVE
Important dates
- Study start
- 2021
- Primary completion
- 2022
- Study completion
- 2022
- First posted
- May 9, 2019
- Registry last updated
- Mar 10, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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