Study protocol of the multicentre, randomised, triple-blind, placebo-controlled MERCURI-2 trial: promoting effective renoprotection in cardiac surgery patients by inhibition of sodium glucose cotransporter (SGLT)-2

BMJ Open, vol. 15, pp. e095504

Abstract

INTRODUCTION: Acute kidney injury (AKI) is a major complication after cardiac surgery and is associated with postoperative morbidity and mortality. Currently, no effective therapy exists to reduce the incidence of postoperative AKI. Sodium-glucose cotransporter-2 (SGLT2) inhibitors are effective in reducing AKI in outpatient settings for patients with chronic kidney disease. We hypothesised that perioperative SGLT2 inhibition will also reduce AKI incidence after cardiac surgery according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria. METHODS AND ANALYSIS: We designed a multicentre, randomised, placebo-controlled, triple-blinded, superiority trial. A total of 784 patients, aged above 18 years, undergoing cardiac surgery will be included with stratification for sex and type 2 diabetes in a 1:1 ratio. Patients will receive either dapagliflozin 10 mg or placebo from the day before until 2 days after surgery. Serum creatinine will be measured preoperatively and daily for the first 7 days after the operation, and urine output will be measured until the urinary catheter is removed. The primary outcome is the incidence of postoperative AKI according to the KDIGO criteria. ETHICS AND DISSEMINATION: The medical ethics committee of the Amsterdam University Medical Centre (UMC) and the Dutch competent authority approved the study protocol (currently, version 9, 19 January 2024). This is an investigator-initiated study. The Amsterdam UMC, as sponsor, retains ownership of all data and publication rights. After completion of the trial, results will be disseminated to participants, patient societies and physicians via a network meeting and digital newsletter. Results will be submitted for publication in a peer-reviewed international medical journal and presented on (inter)national congresses. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov identifier: NCT05590143.

Authors 16

1. Maartina J P Oosterom-Eijmael

   Amsterdam UMC Location University of Amsterdam · Amsterdam University Medical Centers · Amsterdam Cardiovascular Sciences

   Affiliation as printed

   Amsterdam Cardiovascular Sciences Research Institute, Amsterdam, The Netherlands

   Department of Anesthesiology, Amsterdam University Medical Center, Amsterdam, The Netherlands

   Department of Endocrinology, Amsterdam University Medical Center, Amsterdam, The Netherlands

   Department of Anesthesiology, Amsterdam University Medical Center, Amsterdam, The Netherlands m.j.p.eijmael@amsterdamumc.nl

2. Ed D Niesten

   Medisch Spectrum Twente

   Affiliation as printed

   Department of Anesthesiology, Medisch Spectrum Twente, Enschede, The Netherlands

3. Martijn Tolsma

   Isala

   Affiliation as printed

   Department of Anesthesiology and Intensive Care, Isala Clinics, Zwolle, The Netherlands

4. Ferdinand T. Snellen

   Isala

   Affiliation as printed

   Department of Anesthesiology and Intensive Care, Isala Clinics, Zwolle, The Netherlands

5. Bas M. Gerritse

   Amphia Ziekenhuis

   Affiliation as printed

   Anaesthesiology, Amphia Ziekenhuis, Breda, North Brabant, The Netherlands

6. Thierry V. Scohy

   Amphia Ziekenhuis

   Affiliation as printed

   Anaesthesiology, Amphia Ziekenhuis, Breda, North Brabant, The Netherlands

7. Thijs C. D. Rettig

   Amphia Ziekenhuis

   Affiliation as printed

   Anesthesiology, Intensive Care and Pain Medicine, Amphia Hospital site Molengracht, Breda, Noord-Brabant, The Netherlands

8. Marc Bernard Godfried

   OLVG

   Affiliation as printed

   Department of Anesthesiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, Noord-Holland, The Netherlands

9. Magiel F Voogd

   Medisch Centrum Leeuwarden

   Affiliation as printed

   Department of Anesthesiology, Medisch Centrum Leeuwarden, Leeuwarden, The Netherlands

10. Jeroen Wink Aachen Department of Anesthesiology, Leiden University Medical Center

    Leiden University Medical Center

    Affiliation as printed

    Department of Anesthesiology, Leiden University Medical Center, Leiden, The Netherlands

11. Lisa Mm van der Werff Aachen Department of Anesthesiology, Leiden University Medical Center

    Leiden University Medical Center

    Affiliation as printed

    Department of Anesthesiology, Leiden University Medical Center, Leiden, The Netherlands

12. Susanne Eberl

    Amsterdam UMC Location University of Amsterdam · Amsterdam University Medical Centers

    Affiliation as printed

    Department of Anesthesiology, Amsterdam University Medical Center, Amsterdam, The Netherlands

13. Benedikt Preckel

    Amsterdam UMC Location University of Amsterdam · Amsterdam University Medical Centers

    Affiliation as printed

    Department of Anesthesiology, Amsterdam University Medical Center, Amsterdam, The Netherlands

14. Jeroen Hermanides

    Amsterdam UMC Location University of Amsterdam · Amsterdam University Medical Centers

    Affiliation as printed

    Department of Anesthesiology, Amsterdam University Medical Center, Amsterdam, The Netherlands

15. Daniël H. van Raalte

    Amsterdam University Medical Centers · Amsterdam Cardiovascular Sciences

    Affiliation as printed

    Amsterdam Cardiovascular Sciences Research Institute, Amsterdam, The Netherlands

    Department of Endocrinology, Amsterdam University Medical Center, Amsterdam, The Netherlands

16. Abraham Hendrikus Hulst

    Amsterdam UMC Location University of Amsterdam · Amsterdam University Medical Centers

    Affiliation as printed

    Department of Anesthesiology, Amsterdam University Medical Center, Amsterdam, The Netherlands