CompletedPhase 4

Metabolic and Renal Outcomes in Cardiac Surgery Patients Receiving SGLT2 Inhibitors

Netherlands60 participantsStarted 2022-03-03

Plain-language 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.

Who can participate

Age range18 Years – 90 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

NGAL

Timeframe: Day 2 post surgery

Trial details

NCT IDNCT06825156

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-26

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