Preemptive Pharmacogenetic-guided Metoprolol Management for PostoperativeAtrial Fibrillation in Cardiac Surgery

Not Applicable

Completed

• Conditions: Post-operative Atrial Fibrillation
• Interventions: Other: Guided Metoprolol Management

• Registration Number: NCT03943927
• Lead Sponsor: Vanderbilt University Medical Center

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-05-07
• Study First Submitted QC: 2019-05-07
• Study First Posted: 2019-05-09
• Study Start: 2021-03-05
• Primary Completion: 2022-10-24
• Study Completion: 2022-11-20
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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

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Exclusion Criteria

• History of allergic reactions or contraindications to beta-blockers
• Patients with persistent atrial fibrillation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pharmacogenetic-guided metoprolol management	Guided Metoprolol Management	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
Length of hospital stay	From end of surgery to hospital discharge; usually 3-4 days	Length of hospital stay (in days) after surgery
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.
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).

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States