Metabolic and Renal Outcomes in Cardiac Surgery Patients Receiving SGLT2 Inhibitors (MERCURI)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status and phase: Completed; Phase 4

Conditions: Acute Kidney Injury

Treatments: Drug: Empagliflozin 10 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT06825156

NL78156.018.21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Controlled (usual care)

No Intervention group

Description:

Standard of care, Some additional blood drawn and urine collected to compare between both groups

Intervention(Medication group)

Experimental group

Description:

Patients receive 10mg Empagliflozin(SLGT-2i) daily from 3 days prior to surgery untill 2 days post-surgery which includes day of surgery.

Treatment:

Drug: Empagliflozin 10 MG