BMJ open · 2025
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.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Oosterom-Eijmael Maartina, Monteiro de Oliveira Nelson P, Niesten Ed D, Tolsma Martijn, Snellen Ferdinand Tf, Gerritse Bas M, Scohy Thierry V, Rettig T, Godfried M B, Voogd Magiel F, Wink Jeroen, van der Werff Lisa Mm, Eberl Susanne, Preckel Benedikt, Hermanides Jeroen, van Raalte Daniel H, Hulst Abraham H, MERCURI-2 study group
Аннотация
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.
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.