• Alexander Zarbock, Lui G Forni, Jay L Koyner, Samira Bell, Thiago Reis, Melanie Meersch, Sean M Bagshaw, Dana Y Fuhmann, Kathleen D Liu, Neesh Pannu, ArikanAyse AkcanAADivision of Nephrology and Critical Care Medicine, Department of Pediatric, Baylor College of Medicine, Houston, TX, USA., Derek C Angus, D'Arcy Duquette, Stuart L Goldstein, Eric Hoste, Michael Joannidis, Niels Jongs, Matthieu Legrand, Ravindra L Mehta, Patrick T Murray, Mitra K Nadim, Marlies Ostermann, John Prowle, Emily J See, Nicholas M Selby, Andrew D Shaw, Nattachai Srisawat, Claudio Ronco, and John A Kellum.
• Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital of Münster, Albert-Schweitzer Campus 1, Building A1, 48149, Münster, Germany. zarbock@uni-muenster.de.
• Intensive Care Med. 2024 Sep 1; 50 (9): 142614371426-1437.

PurposeNovel interventions for the prevention or treatment of acute kidney injury (AKI) are currently lacking. To facilitate the evaluation and adoption of new treatments, the use of the most appropriate design and endpoints for clinical trials in AKI is critical and yet there is little consensus regarding these issues. We aimed to develop recommendations on endpoints and trial design for studies of AKI prevention and treatment interventions based on existing data and expert consensus.MethodsAt the 31st Acute Disease Quality Initiative (ADQI) meeting, international experts in critical care, nephrology, involving adults and pediatrics, biostatistics and people with lived experience (PWLE) were assembled. We focused on four main areas: (1) patient enrichment strategies, (2) prevention and attenuation studies, (3) treatment studies, and (4) innovative trial designs of studies other than traditional (parallel arm or cluster) randomized controlled trials. Using a modified Delphi process, recommendations and consensus statements were developed based on existing data, with > 90% agreement among panel members required for final adoption.ResultsThe panel developed 12 consensus statements for clinical trial endpoints, application of enrichment strategies where appropriate, and inclusion of PWLE to inform trial designs. Innovative trial designs were also considered.ConclusionThe current lack of specific therapy for prevention or treatment of AKI demands refinement of future clinical trial design. Here we report the consensus findings of the 31st ADQI group meeting which has attempted to address these issues including the use of predictive and prognostic enrichment strategies to enable appropriate patient selection.© 2024. The Author(s).

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