SGLT2i have been shown to reduce risk for mortality, progression of chronic kidney disease, and cardiovascular outcomes in these populations. Yet, because SGLT2i can have an acute hemodynamic effect on kidney function, in clinical practice providers are wary of providing these medications to patients who have established indications but recently had acute kidney injury (AKI). This is a pilot interventional study to collect process-data (measures of recruitment and measures of adherence) that can be used to establish feasibility for a larger pilot randomized trial in the future. The study aims to conduct a small randomized intervention trial with two arms, with approximately 10-12 patients in the intervention arm and 5-6 in the control arm. The intervention will be providing a prescription for a SGLT2i based on established criteria for this FDA-approved class of drugs, and the control will be usual care (through which, control arm participants will also have access to this FDA-approved class of drugs - expect receipt of a SGLT2i in the control arm to be rare, but a degree of crossover will be expected).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
a starting dose of a SGLT2i will be prescribed for the participant for pickup at discharge via the UMMC discharge pharmacy. The preferred prescription will be empagliflozin (Jardiance) 10mg daily with a 90-day fill and no refills, but this can be adjusted to other SGLT2i or other doses in the outpatient setting by either Dr. Murphy or by the participants' established providers, typically based on insurance company preferences among the three FDA-approved SGLT2i.
University of Minnesota
Minneapolis, Minnesota, United States
SGLT2i use
proportion of patients in each arm of the study using a SGLT2i at one month of follow-up.
Time frame: 1 month
number of participants who obtained follow-up basic metabolic panel
How many participants in each arm of the study obtain follow-up basic metabolic panel lab testing prior to the one-month (+/- 10 days) follow-up phone call.
Time frame: 1 month
screening feasibility
How many patients we screen for every candidate we identify
Time frame: 1 month
participation rate
How many candidate-patients we approach who enroll in the study as participants.
Time frame: 1 year
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