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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

Por: Oosterom-Eijmael · M. · Monteiro de Oliveira · N. P. · Niesten · E. D. · Tolsma · M. · Snellen · F. T. · Gerritse · B. M. · Scohy · T. V. · Rettig · T. · Godfried · M. B. · Voogd · M. F. · Wink · J. · van der Werff · L. M. · Eberl · S. · Preckel · B. · Hermanides · J. · van Raalte · D
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.

How to age right and care(fully) at home? A protocol for a multistage comparative study of ageing in place and hospital at home care across three countries

Por: Sturge · J. · Nordin · S. · Pilosof · N. P. · Vogt · T. · Janus · S. I. M. · Ludden · G. · Helder · R. · Kylen · M. · Zimlichman · E. · Glazer · J.
Introduction

Ageing right care(fully) is a transnational research study which explores and maps an understanding of the care pathways between ageing in place and hospital at home policy and practices for older adults in Israel, the Netherlands and Sweden. The countries are suited to be compared where they have growing, ageing populations, a focus on healthcare reform and several policies to reduce the cost of care for older populations. Ageing in place is a government-led policy that is often associated with choice; however, there is a recent debate about whether ageing in place is a universal desire for all older adults. Research shows that the care pathway between the hospital and the home, associated with ageing in place, can impact well-being, especially if the built, social and technological environments do not meet the healthcare needs and preferences of older adults. This is significant as new programmes for digital hospital at home innovations are being developed as part of a global transformation in healthcare systems. The aim of the study is to compare different approaches to ageing in place and hospital at home care in different regions. The multiapproach study explores the demographics, policy structure, decision-making process and the crucial role of the built, social and technological environments along the hospital to home care pathways of older adults.

Methods and analysis

The mixed-method, comparative study includes a new multienvironment theoretical contribution explored across a three-phase research method to understand the care pathways of older adults ageing in place receiving hospital at home care. The first phase compares each country’s population and policy structures relating to ageing in place, hospital discharge, home hospitalisation and at-home care for older adults. The second phase maps patient journeys of older adults living in each country through the perspective of the older adult, caregivers and care professionals. The third phase explores the synergies between the knowledge gained through phases 1 and 2—from a policy and a personal level—and mobilises the knowledge into policy recommendations and implementation guidelines.

Ethics and dissemination

The comparative study has been approved by the Sheba Medical Centre in Israel (SMC-1330-24), the Ethics Committee of Tel Aviv University (0009216-2), the Humanities and Social Science Ethics Committee at the University of Twente in the Netherlands (240040) and the Swedish Ethical Review Authority (Dnr 2024-07569-01). The results will be shared with end-users, including citizens, carers, healthcare policymakers, planners, architects and designers, through social media, publications, workshops and international conferences. This future-focused research approach will allow stakeholders to rethink and imagine ways that health and care systems can be personalised and responsive to the future needs of older adult populations.

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