Personalised recommendations for hospitalised patients with Acute Kidney Injury using a Kidney Action Team (KAT-AKI): protocol and early data of a randomised controlled trial
Natasha Freeman,
Melissa Martin,
Yu Yamamoto,
Chirag Parikh,
Francis P Wilson,
Abigail Smith,
Charles Jones,
Megan L Baker,
Abinet Mathias Aklilu,
Kyle D O’Connor,
Claudia Coronel-Moreno,
Kristina Shvets,
Bashar Kadhim,
Celia P Corona-Villalobos,
Jiawei Tan,
Marwin Groener,
Steven Menez,
Dannielle Brown,
Samuel E Culli,
John Lindsley,
Marcelo Orias,
Anusha Sundararajan
Affiliations
Natasha Freeman
Department of Internal Medicine, Yale New Haven Hospital, New Haven, Connecticut, USA
Melissa Martin
research associate
Yu Yamamoto
6 Division of General Medicine, Center for Community Medicine, Jichi Medical University, Tochigi, Japan
Chirag Parikh
Division of Nephrology, Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland, USA
Francis P Wilson
Section of Nephrology, Department of Internal Medicine, Yale New Haven Hospital, New Haven, Connecticut, USA
Abigail Smith
Population, Policy and Practice Research Programme, UCL Great Ormond Street Institute of Child Health, London, UK
Charles Jones
Department of Pharmacology, Yale New Haven Hospital, New Haven, Connecticut, USA
Megan L Baker
Section of Nephrology, Department of Internal Medicine, Yale New Haven Hospital, New Haven, Connecticut, USA
Abinet Mathias Aklilu
Clinical and Translational Research Accelerator, Yale School of Medicine, New Haven, Connecticut, USA
Kyle D O’Connor
1 Clinical and Translational Research Accelerator, Department of Medicine, Yale School of Medicine, New Haven, Connecticut, USA
Claudia Coronel-Moreno
Clinical and Translational Research Accelerator, Yale School of Medicine, New Haven, Connecticut, USA
Kristina Shvets
Department of Pharmacology, Yale New Haven Hospital, New Haven, Connecticut, USA
Bashar Kadhim
Clinical and Translational Research Accelerator, Yale School of Medicine, New Haven, Connecticut, USA
Celia P Corona-Villalobos
Division of Nephrology, Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland, USA
Jiawei Tan
Department of Internal Medicine, Bridgeport Hospital, Bridgeport, Connecticut, USA
Marwin Groener
Department of Internal Medicine, Yale New Haven Hospital, New Haven, Connecticut, USA
Steven Menez
Division of Nephrology, Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland, USA
Dannielle Brown
Department of Pharmacology, The Johns Hopkins Hospital, Baltimore, Maryland, USA
Samuel E Culli
Department of Pharmacy, The Johns Hopkins Hospital, Baltimore, Maryland, USA
John Lindsley
Department of Pharmacy, The Johns Hopkins Hospital, Baltimore, Maryland, USA
Marcelo Orias
Section of Nephrology, Department of Internal Medicine, Yale New Haven Hospital, New Haven, Connecticut, USA
Anusha Sundararajan
Section of Nephrology, Department of Internal Medicine, Yale New Haven Hospital, New Haven, Connecticut, USA
Introduction Although studies have examined the utility of clinical decision support tools in improving acute kidney injury (AKI) outcomes, no study has evaluated the effect of real-time, personalised AKI recommendations. This study aims to assess the impact of individualised AKI-specific recommendations delivered by trained clinicians and pharmacists immediately after AKI detection in hospitalised patients.Methods and analysis KAT-AKI is a multicentre randomised investigator-blinded trial being conducted across eight hospitals at two major US hospital systems planning to enrol 4000 patients over 3 years (between 1 November 2021 and 1 November 2024). A real-time electronic AKI alert system informs a dedicated team composed of a physician and pharmacist who independently review the chart in real time, screen for eligibility and provide combined recommendations across the following domains: diagnostics, volume, potassium, acid–base and medications. Recommendations are delivered to the primary team in the alert arm or logged for future analysis in the usual care arm. The planned primary outcome is a composite of AKI progression, dialysis and mortality within 14 days from randomisation. A key secondary outcome is the percentage of recommendations implemented by the primary team within 24 hours from randomisation. The study has enrolled 500 individuals over 8.5 months. Two-thirds were on a medical floor at the time of the alert and 17.8% were in an intensive care unit. Virtually all participants were recommended for at least one diagnostic intervention. More than half (51.6%) had recommendations to discontinue or dose-adjust a medication. The median time from AKI alert to randomisation was 28 (IQR 15.8–51.5) min.Ethics and dissemination The study was approved by the ethics committee of each study site (Yale University and Johns Hopkins institutional review board (IRB) and a central IRB (BRANY, Biomedical Research Alliance of New York). We are committed to open dissemination of the data through clinicaltrials.gov and sharing of data on an open repository as well as publication in a peer-reviewed journal on completion.Trial registration number NCT04040296.
