Acute Kidney Injury
Conditions
Keywords
CSA-AKI, SGLT-2i, Cardiac surgery
Brief summary
To investigate the potential of preoperative initiation (3 days) and perioperative continuation (until day 2 after surgery) of empagliflozin(sodium glucose co transporter 2 inhibitor(SGLT-2i)) 10 mg daily to reduce the acute kidney injury marker neutrophil gelatinase-associated lipocalin (NGAL) measured in serum and urine on day 2 postoperatively in patients undergoing cardiopulmonary bypass surgery by comparing a study medication group to a control group in an open-label set-up.
Detailed description
Adult patients scheduled for elective cardiopulmonary bypass assisted cardiothoracic surgery will be informed about the study and after receiving informed consent will be divided between two groups in an openlabel fashion: Intevention group: Takes study medication(10mg Empagliflozin once a day in the morning) 3 days prior to surgery, day of surgery and 2 days post-surgery. Control group: follows the usual standard of care. At time moment before surgery and before medication is taken blood and urine sample is taken. This is repeated on day of surgery, and the consecutive 2 days after surgery. Form these samples biomakers for kidney injury will be measured and compared between groups.
Interventions
DRUGEmpagliflozin 10 MG
Patients receive 10mg Empagliflozin(SLGT-2i) daily from 3 days prior to surgery untill 2 days post-surgery which includes day of surgery.
Sponsors
European Commission
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Single-center, open-label parallel-group randomized, controlled(usual care), phase IV clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 18 to 90 years old (inclusive) * Undergoing elective cardiac surgery with cardio-pulmonary bypass. * Providing informed consent
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 | Description |
|---|---|---|
| NGAL | Day 2 post surgery | Neutrophil gelatinase-associated lipocalin (NGAL) concentration in plasma on postoperative day 2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neutrophil gelatinase-associated lipocalin (NGAL) concentration in plasma. | Before surgery, day of surgery, day 1+2 after surgery | NGAL measured in plasma |
| Kidney Injury Molecule-1 (KIM-1) in plasma. | Before surgery, day of surgery, day 1+2 after surgery | KIM-1 concentration measured in plasma |
| Perioperative peak and average blood glucose levels, as measured during usual care. | During study per untill 4 days post-operatively | Glucose levels recorded during usual routine care |
| Blood ketone levels. | During surgery at 4 measurement moments or during usual care. | Blood ketones measured intra-operatively |
| Renal functioning (KDIGO criteria) | During study period untill post-operative day 4 | development of serum creatinine levels and urine output measured untill post-operative day 4 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Ketoacidosis | During study period untill post-operative day 4 | Incidence of keto-acidosis defined as combination of blood ketone concentration \>3mmol/l in combination with high-anion gap acidosis (\[Na+\]-\[Cl-\]-\[HCO3-\]\>12). |
| Hypoglycemia | During study period untill post-operative day 4 | Incidence of Hypoglycemia during study period |
Countries
Netherlands
Outcome results
None listed