SGLT2 Inhibitors After Acute Kidney Injury With Indications Pilot
- Conditions
- Acute Kidney Injury
- Registration Number
- NCT06124924
- Lead Sponsor
- University of Minnesota
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Terminated
- Sex
- All
- Target Recruitment
- 1
Inclusion Criteria:<br><br> - Type 2 diabetes mellitus, as indicated by review of the candidate's chart, as<br> confirmed by interviewing the participant prior to randomization as part of the<br> consent process, and documentation of at least one non-insulin diabetes medication<br> that are specific to type 2 diabetes mellitus (with concurrent insulin use allowed)<br> based on outpatient medication reconciliation documented in the inpatient medical<br> notes and medication tab of Epic. SGLT2i are considered first- line therapy for type<br> 2 diabetes mellitus.<br><br> - Age 40 to 75 years at time of screening. This age range is chosen to decrease the<br> likelihood of pregnancy while also increasing the likelihood of participants having<br> adequate life expectancy to benefit from SGLT2i use.<br><br> - No positive pregnancy test results during the current hospitalization (or from a<br> transferring hospital or transferring emergency room) or documentation in the<br> electronic medical chart of an existing pregnancy. For candidates for the study who<br> are female of childbearing age <55 years (an approximate upper limit for<br> menopause) with a urine sample in the UMMC laboratory available to add-on a urine<br> pregnancy test, Dr. Murphy will ask the primary team or nephrology team to add-on<br> that test if medical relevant (pregnancy is virtually always medically relevant). If<br> they cannot (because no urine sample is available or they determine it is not<br> medically relevant), that patient will no longer be considered a study- candidate.<br><br> - AKI occurring during the index hospitalization or present-on-admission, with a<br> nephrology consult active after the onset of the AKI. The nephrology consult team<br> need not be active at the time of study enrollment, though, if not medically needed<br> any longer.<br><br> - Serum creatinine concentration that has peaked and has begun to improve (defined as<br> a creatinine =0.30 mg/dL below the maximum serum creatinine concentration measured<br> during the index hospitalization).<br><br> - Serum creatinine concentration that is no higher than 0.05 mg/dL higher on the day<br> of randomization than compared to the most recent serum creatinine concentration =12<br> hours prior.<br><br> - A current creatinine-based eGFR =45 mL/min/1.73 m 2 (which, due to the stable-<br> to-improving serum creatinine concentration requirements, as above, would indicate<br> an eGFR that is truly =45 mL/min/1.73 m 2 ). eGFR =45 mL/min/1.73 m 2 is the most<br> cautious eGFR threshold published among the three commercially available SGLT2i. 6,7<br><br> - A high likelihood, based on assessment of their medical chart, for discharge in the<br> coming days with a plan to discharge to home without hospice services (meaning: not<br> discharging to a rehabilitation facility or another hospital).<br><br>Exclusion Criteria:<br><br> - Vulnerable populations, including those with cognitive disorders (as noted in<br> problem lists and active inpatient notes from the index hospitalization), pregnant<br> patients, incarcerated patients, etc. will not be candidates for this study.<br><br> - If non-English speaking, a lack of available in-person interpreter within UMMC will<br> be an exclusion criteria.<br><br> - A prior history of intolerance to a SGLT2i, as documented in the patient's allergy<br> list and upon interviewing the candidate prior to randomization during the<br> consenting process.<br><br> - If the candidate reports that they would object to taking a diuretic medication<br> that, according to its mechanism of action, will increase their daily urinary<br> volume, that will preclude study enrollment.<br><br> - Current treatment for a urinary tract infection of genital infection, defined by<br> inpatient medical notes, or the candidate reporting a medical history of recurrent<br> urinary tract infections will preclude study enrollment.<br><br> - Hypoglycemia, defined as a blood glucose concentration, <60 mg/dL, during the<br> hospitalization prior to randomization or the candidate reporting a medical history<br> of recurrent hypoglycemia will preclude study enrollment.<br><br> - Both the consulting nephrology team and the primary inpatient team will be contacted<br> before the patient is contacted, and they will be empowered to opt- out the patient<br> if they do not think the patient is appropriate to receive a SGLT2i at this time. If<br> Dr. Murphy is one of the staff physicians for the day for the candidate-patient,<br> that patient will be excluded to avoid conflicts of interest or undue pressure on<br> the patient. The patient can be one of Dr. Murphy's established outpatient or can be<br> scheduled for AKI-nephrology follow-up after discharge with Dr. Murphy in the<br> outpatient setting.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method SGLT2i use
- Secondary Outcome Measures
Name Time Method number of participants who obtained follow-up basic metabolic panel;screening feasibility;participation rate