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| Name | Class |
|---|---|
| European Commission | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Controlled (usual care) | No Intervention | Standard of care, Some additional blood drawn and urine collected to compare between both groups | |
| Intervention(Medication group) | Experimental | Patients receive 10mg Empagliflozin(SLGT-2i) daily from 3 days prior to surgery untill 2 days post-surgery which includes day of surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin 10 MG | Drug | Patients receive 10mg Empagliflozin(SLGT-2i) daily from 3 days prior to surgery untill 2 days post-surgery which includes day of surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| NGAL | Neutrophil gelatinase-associated lipocalin (NGAL) concentration in plasma on postoperative day 2 | Day 2 post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Neutrophil gelatinase-associated lipocalin (NGAL) concentration in plasma. | NGAL measured in plasma | Before surgery, day of surgery, day 1+2 after surgery |
| Kidney Injury Molecule-1 (KIM-1) in plasma. |
| Measure | Description | Time Frame |
|---|---|---|
| Ketoacidosis | Incidence of keto-acidosis defined as combination of blood ketone concentration >3mmol/l in combination with high-anion gap acidosis ([Na+]-[Cl-]-[HCO3-]>12). | During study period untill post-operative day 4 |
| Hypoglycemia |
Inclusion Criteria:
Exclusion Criteria:
Current treatment with SGLT2 inhibitors.
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| Name | Affiliation | Role |
|---|---|---|
| Jeroen Hermanides, Dr. | Amsterdam University Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam University Medical Centre | Amsterdam-Zuidoost | North Holland | 1105 AZ | Netherlands |
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| Label | URL |
|---|---|
| Link of the former published study protocol, National register of the Netherlands has ceased to exist. | View source |
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Protocol
at least 5 years after publication
Relevant reason to validate the request for access of this data
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
| D000077203 | Sodium-Glucose Transporter 2 Inhibitors |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
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Single-center, open-label parallel-group randomized, controlled(usual care), phase IV clinical trial
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|
KIM-1 concentration measured in plasma
| Before surgery, day of surgery, day 1+2 after surgery |
| Perioperative peak and average blood glucose levels, as measured during usual care. | Glucose levels recorded during usual routine care | During study per untill 4 days post-operatively |
| Blood ketone levels. | Blood ketones measured intra-operatively | During surgery at 4 measurement moments or during usual care. |
| Renal functioning (KDIGO criteria) | development of serum creatinine levels and urine output measured untill post-operative day 4 | During study period untill post-operative day 4 |
Incidence of Hypoglycemia during study period
| During study period untill post-operative day 4 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D045505 | Physiological Effects of Drugs |