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Completed

NCT Number: NCT06825156

Metabolic and Renal Outcomes in Cardiac Surgery Patients Receiving SGLT2 Inhibitors

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Amsterdam University Medical Centre

Amsterdam-Zuidoost, North Holland, 1105 AZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Gliflozin, SGLT-2i

Primary outcomes

  1. NGAL

    Time frame: Day 2 post surgery

    Neutrophil gelatinase-associated lipocalin (NGAL) concentration in plasma on postoperative day 2

Secondary outcomes

  1. Neutrophil gelatinase-associated lipocalin (NGAL) concentration in plasma.

    Time frame: Before surgery, day of surgery, day 1+2 after surgery

    NGAL measured in plasma

  2. Kidney Injury Molecule-1 (KIM-1) in plasma.

    Time frame: Before surgery, day of surgery, day 1+2 after surgery

    KIM-1 concentration measured in plasma

  3. Perioperative peak and average blood glucose levels, as measured during usual care.

    Time frame: During study per untill 4 days post-operatively

    Glucose levels recorded during usual routine care

  4. Blood ketone levels.

    Time frame: During surgery at 4 measurement moments or during usual care.

    Blood ketones measured intra-operatively

  5. Renal functioning (KDIGO criteria)

    Time frame: During study period untill post-operative day 4

    development of serum creatinine levels and urine output measured untill post-operative day 4

Other outcomes

  1. Ketoacidosis

    Time frame: 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).

  2. Hypoglycemia

    Time frame: During study period untill post-operative day 4

    Incidence of Hypoglycemia during study period

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • European Commission

Registry information

Official study title

The Perioperative Renal and Metabolic Outcomes After Sodium Glucose Cotransporter 2 Inhibitor in Cardiac Surgery - an Open-label Phase IV Randomized Controlled Trial

Acronym: MERCURI

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 13, 2025
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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