The perioperative renal and metabolic outcomes after sodium-glucose cotransporter-2 inhibitor in cardiac surgery - an open-label phase IV randomized controlled trial

The perioperative renal and metabolic outcomes after sodium-glucose cotransporter-2 inhibitor in cardiac surgery - an open-label phase IV randomized controlled trial - The MERCURI trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52118

Enrollment

Registered

2021-09-27

Start date

2022-03-21

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute kidney injury acute renal failure cardiac surgery-associated kidney injury

Interventions

The intervention group receives once daily 10 mg empagliflozin starting 7 days before surgery to be continued until two days postoperatively. The control group will follow usual perioperative care.

Eligibility

Age

18 Years to 99 Years

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

Design outcomes

Primary

Measure	Time frame
Neutrophil gelatinase-associated lipocalin (NGAL) concentration in plasma, measured on the 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	—

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)