Acute Kidney Injury, Percutaneous Coronary Intervention
Conditions
Keywords
SGLT2 inhibitor, Dapagliflozin, AKI, PCI, Angiography
Brief summary
To compare the incidence of acute kidney injury (AKI) post percutaneous coronary intervention (PCI) in a Dapagliflozin treated group versus a group managed with the usual standard of care.
Interventions
DRUGDapagliflozin 10mg Tab
One tablet daily starting 48h prior to PCI and continuing for 48h post-PCI.
Sponsors
Albert Einstein Healthcare Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age 18 years or more. 2. Scheduled/non-emergent Percutaneous coronary intervention (PCI). 3. Post-index procedure Staged PCI with at least 14 days from contrast exposure. 4. Patient can fully understand the study information and sign informed consent.
Exclusion criteria
1. Cardiogenic shock /need for inotrope or mechanical pump support. 2. Acute kidney injury as defined by KDIGO criteria (\<4 weeks) prior to PCI. 3. End-Stage Renal Disease prior to PCI (On renal replacement therapy). 4. Diabetes Mellitus type 1. 5. Active diabetic ketoacidosis or uncontrolled hyperglycemia (blood glucose \>400 mg/dl). 6. ST-segment elevation Myocardial Infarction undergoing index PCI. 7. Active Genitourinary infection. 8. Diagnostic Left Heart Catheterization without PCI. 9. Patients undergoing zero contrast PCI. 10. Participation in a randomized controlled pharmaceutical or treatment-related cardiac or pulmonary clinical study within 1 month prior to randomization. 11. Coexistent hemodynamically significant valvulopathy (Symptomatic and/or severe). 12. Patients with Acute Heart Failure admission \< 30 days prior to PCI. 13. Intercurrent illness resulting in volume depletion and hypotension (MAP\<60 mmHg). 14. Patients with a kidney transplant. 15. Any contrast exposure within 14 days. 16. Patients with estimated glomerular filtration rate (eGFR) \< 25 cc/min (Recommended eGFR threshold by Food and Drug Administration labeling). 17. Patients with an active intrinsic inflammatory or autoimmune renal pathology. 18. Women of child bearing age (\<50 years old). 19. Prison Inmates
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Kidney Injury | Within 7 days. | According to the Kidney Disease Improving Global Outcomes (KDIGO) 2012 definition: increase in serum creatinine by ≥ 0.3 mg/dl (≥ 26.5 μmol/l) within 48 hours or increase in serum creatinine (SCr) to ≥ 1.5 times the known baseline which is known or presumed to have occurred within the prior 7 days. We will measure Urine Neutrophil Gelatinase-associated Lipocalin (UNGAL) at least 6 hours post-PCI and Serum Creatinine at follow up within 7 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | 7 days | Days |
| Incidence of genitourinary infections | 7 days | Symptomatic pyuria or new vaginal infection. |
Countries
United States
Outcome results
None listed