Acute Kidney Injury, Left Cardiac Catheterization, Percutaneous Coronary Intervention, Sodium-glucose Co-transporter 2 Inhibitors
Conditions
Keywords
dapaglifozin, iodinated contrast media, Sodium-glucose Co-transporter 2 Inhibitors, Acute Kidney Injury
Brief summary
Left heart catheterization and percutaneous coronary intervention (PCI) has become a useful tool in interventional cardiology, in which iodinated contrast media is used. Although the use of iodinated contrast media (CM) is considered to be safe in patients with normal renal function, it is risky in patients with known chronic renal insufficiency (CKD) and diabetes mellitus. Contrast induced nephropathy (CIN) remains one of the most leading causes of in hospital acute kidney injury (AKI), affecting morbidity and mortality. There are various mechanisms through which CM develop their nephrotoxic effects, including renal vasoconstriction and medullary hypoxia, tubular cell toxicity and reactive oxygen species formation. Inhibitors of type 2 sodium- glucose co-transporter (SGLT2i) is a relatively recent addition to the array of anti-diabetic agents, becoming part of everyday clinical practice. However, although SGLT2i were first used solely as antidiabetics because of their glycosuric effect, further research demonstrated that these drugs may independently reduce cardiovascular events, especially in patients with heart failure, a benefit that was consistent among diabetic and non-diabetic patients. Moreover, pleiotropic effects have been observed, including a reno-protective action. In addition to the effects mediated by intrarenal hemodynamic changes, SGLT2-i also have direct anti-inflammatory and antifibrotic nephroprotective effects. Indeed, SGLT2-i suppress the production of reactive oxygen species, lessening glomerulosclerosis and tubulo-interstitial fibrosis. These findings suggest that the use of SGLT2i could offer benefit by reducing/ preventing the nephrotoxic effects of contrast media leading to the assumption that the use of these drugs could prevent the incidence nephropathy after cardiac catheterization and percutaneous coronary intervention.
Interventions
Patients randomized in this arm will receive dapagliflozin at a dose of 5mg once daily.
DRUGPlacebo
Patients randomized in this arm will receive placebo.
Sponsors
Attikon Hospital
G.Gennimatas General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Age\>18 years * Written informed consent * Glomerular Filtration Rate (GFR)≥ 30 ml/min/1.73m2 \[CKD stage G1-G3\] * Percutaneous coronary intervention in patients with NSTEMI, UA, STCD and asymptomatic patients
Exclusion criteria
* Active malignancy * Participation in other intervention study * Class I or equivalent indication for treatment with a SGLT2 inhibitor * Pregnancy or willing of pregnancy during the follow up period * Active urogenital infection * Diabetes mellitus type 1 * History of diabetic ketoacidosis * Cardiogenic shock * eGFR \< 29 ml/min/1.73m2 * Patients with an indication for SGLT2 inhibitor will be included in a prospective registry. Their treatment will be determined by their attending physicians.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of incidence of acute kidney injury (AKI) between the two study arms | 1 month | AKI is defined defined as an absolute creatinine level increase of at least 0.3 mg/dL (≥26.5 μmol/L) or at least 1.5-fold from baseline. |
Secondary
| Measure | Time frame |
|---|---|
| Development of at least Stage 2 AKI (according to the KDIGO criteria), i.e. Increase in sCR>2.0-fold from baseline. | 1 month |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence (cases per 100 patient-years) of hypoglycemia in both arms Any episode of hypoglycemia defined as serum glucose 60< mg/dl associated with symptoms of hypoglycemia. | 1 month | — |
| Incidence (cases per 100 patient-years)of diabetic ketoacidosis. | 1 month | Any episode of metabolic acidosis (pH\<7.3) with decreased serum bicarbonate (\<18mEq/ml) and |
| Incidence (cases per 100 patient-years)of lower urinary tract infections | 1 month | — |
| Comparison of all cause mortality between the two groups | 1 month | — |
Countries
Greece
Contacts
Primary ContactSpyridon Deftereos, Prof.
Backup ContactGeorgios Giannopoulos, Prof.
Outcome results
None listed