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. 2025 May 16;15(5):e095504.
doi: 10.1136/bmjopen-2024-095504.

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

Maartina Oosterom-Eijmael  1   2   3 , Nelson P Monteiro de Oliveira  4 , Ed D Niesten  4 , Martijn Tolsma  5 , Ferdinand Tf Snellen  5 , Bas M Gerritse  6 , Thierry V Scohy  6 , T Rettig  7 , M B Godfried  8 , Magiel F Voogd  9 , Jeroen Wink  10 , Lisa Mm van der Werff  10 , Susanne Eberl  11 , Benedikt Preckel  11 , Jeroen Hermanides  11 , Daniel H van Raalte  2   3 , Abraham H Hulst  11 ; MERCURI-2 study group
Collaborators, Affiliations

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

Maartina Oosterom-Eijmael et al. BMJ Open. .

Erratum in

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.

Keywords: Cardiac surgery; Randomized Controlled Trial; acute kidney injury.

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Conflict of interest statement

Competing interests: DHvR serves as a consultant and received honoraria from Boehringer Ingelheim and Lilly, Merck, Novo Nordisk, Sanofi and AstraZeneca and has received research operating funds from Boehringer Ingelheim and Lilly Diabetes Alliance, AstraZeneca and Novo Nordisk; all honoraria are paid to his employer (Amsterdam University Medical Centers, location VU University Medical Center). All other authors have no completing interest to declare.

Figures

Figure 1
Figure 1. Overview of the proposed advantages of SGLT2 inhibitors in reducing CSA-AKI. CSA-AKI, cardiac surgery-associated acute kidney injury; EPO, erythropoietin; LV, left ventricle; SGTL2, sodium-glucose cotransporter-2.
Figure 2
Figure 2. Treatment algorithm for adjustment of glucose lowering therapy in patients with T2D. DPP4, dipeptidyl peptidase IV; GLP-1 RA, glucagon like peptide-1 receptor agonist; HbA1c, haemoglobin A1c; IU, international unit; SU, sulfonylureas; T2D, type 2 diabetes.
Figure 3
Figure 3. Summary of the study flow of the MERCURI-2 trial. AF, atrial fibrillation; DAH30, days at home in first 30 days; ICU, intensive care unit; MACE, major adverse cardiovascular events; MAKE, major adverse kidney events; OR, operation room; QoRquality of recovery; SGLT2, sodium-glucose cotransporter-2.
See this image and copyright information in PMC

References

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