Cardiac surgery associated acute kidney injury
Conditions
Interventions
Preoperative initiation (7 days before surgery) and perioperative continuation (until day 2 after surgery) of empagliflozin 10 mg daily (10 days total).
Sponsors
Amsterdam UMC location AMC
Eligibility
Inclusion criteria
Inclusion criteria: • 18 to 90 years old (inclusive) • Undergoing elective cardiac surgery with cardio-pulmonary bypass. • Providing informed consent
Exclusion criteria
Exclusion criteria: • Current treatment with SGLT2 inhibitors. • Diabetes Mellitus Type 1 • BMI<25 for people with type 2 diabetes • Reduced renal function at baseline with eGFR < 30 ml/min. • Systolic blood pressure < 100 mmHg at time of inclusion. • Emergency surgery, defined as in need of surgery for medical reasons < 7 days, i.e. “S1-4” according to the Amsterdam UMC classification. • Female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods. • Known or suspected allergy to trial products or other drugs in the same class.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neutrophil gelatinase-associated lipocalin (NGAL) concentration in plasma. Measured on morning of postoperative day 2, between 8:00 and 12:00. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Neutrophil gelatinase-associated lipocalin (NGAL) concentration in plasma. • Kidney Injury Molecule-1 (KIM-1) in plasma. • Estimated Glomerular Filtration Rate (eGFR) based on plasma creatinine measurements. • Ketones in blood. • Incidence of keto-acidosis defined as combination of blood ketone concentration >3mmol/l in combination with high-anion gap acidosis ([Na+]-[Cl-]-[HCO3-]>12). • Perioperative peak and average blood glucose levels, as measured during usual care. • Incidence of hypoglycemia defined as blood glucose measurement < 4 mmol/l at any time point between start of surgery and end of study. Timing of outcome measurements: For NGAL, KIM-1, plasma ketones and incidence of keto-acidosis: -On day of surgery: • Before start of surgery (after placement of arterial line) • At time of start of cardiopulmonary bypass (+/- 20 min) • At the end of cardiopulmonary bypass (+/- 20 min) • At time of transport to ICU (+/- 20 min) -Postoperatively • Measured daily, in the morning between 8:00 and 12:00 until postoperative day 2. For eGFR (creatinine) • Measured daily, in the morning between 8:00 and 12:00 until postoperative day 4. For peak and average glucose and incidence of hypoglycaemia: • any measurement occurring between start of surgery and end of study until postoperative day 4, as part of routine care. | — |
Contacts
Public ContactAbraham Hulst
Amsterdam UMC
Outcome results
None listed