Recommendations for clinical trial design in acute kidney injury from the 31st acute disease quality initiative consensus conference. A consensus statement

Alexander Zarbock (Lead / Corresponding author), Lui G. Forni, Jay L. Koyner, Samira Bell, Thiago Reis, Melanie Meersch, Sean M. Bagshaw, Dana Y. Fuhmann, Kathleen D. Liu, Neesh Pannu, Ayse Akcan Arikan, Derek C. Angus, D‘Arcy Duquette, Stuart L. Goldstein, Eric Hoste, Michael Joannidis, Niels Jongs, Matthieu Legrand, Ravindra L. Mehta, Patrick T. MurrayMitra K. Nadim, Marlies Ostermann, John Prowle, Emily J. See, Nicholas M. Selby, Andrew D. Shaw, Nattachai Srisawat, Claudio Ronco, John A. Kellum

Research output: Contribution to journalArticlepeer-review

4 Citations (Scopus)
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Abstract

Purpose 

Novel 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. 

Methods 

At 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. 

Results 

The 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. 

Conclusion 

The 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.

Original languageEnglish
Pages (from-to)1426-1437
Number of pages12
JournalIntensive Care Medicine
Volume50
Issue number9
Early online date8 Aug 2024
DOIs
Publication statusPublished - Sept 2024

Keywords

  • AKI
  • Clinical trials
  • Endpoints
  • Enrichment
  • Prevention
  • Treatment

ASJC Scopus subject areas

  • Critical Care and Intensive Care Medicine

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