Avoiding misclassification of acute kidney injury: Timing is everything

Amy Legg, Jason A. Roberts, Matthew A. Roberts, Alan Cass, Jane Davies, Steven Y.C. Tong, Joshua S. Davis

Research output: Contribution to journalArticlepeer-review

27 Downloads (Pure)

Abstract

Accurate detection of acute kidney injury (AKI) in clinical trials is important. Using a ‘baseline’ creatinine from trial enrolment may not be ideal for understanding a participant's true baseline kidney function. We aimed to determine if a ‘pre-trial baseline creatinine’ resulted in comparable creatinine concentrations to a ‘trial baseline creatinine’, and how the timing of baseline creatinine affected the incidence of AKI in the Combination Antibiotic therapy for MEthicillin Resistant Staphylococcus aureus (CAMERA2) randomised trial. Study sites retrospectively collected a pre-trial baseline creatinine from up to 1 year before CAMERA2 trial enrolment ideally when the patient was medically stable. Baseline creatinine from CAMERA2 (the ‘trial baseline creatinine’), was the highest creatinine measurement in the 24 h preceding trial randomisation. We used Wilcoxon sign rank test to compare pre-trial and trial baseline creatinine concentrations. We included 217 patients. The median pre-trial baseline creatinine was significantly lower than the median trial baseline creatinine (82 μmol/L [IQR 65–104 μmol/L] versus 86 μmol/L [IQR 66–152 μmol/L] p = <0.001). Using pre-trial baseline creatinine, 48 of 217 patients (22%) met criteria for an AKI at CAMERA2 enrolment and only 5 of these patients met criteria for an AKI using the CAMERA2 study protocol (using baseline creatinine from trial entry). Using a baseline creatinine from the time of trial enrolment failed to detect many patients with AKI. Trial protocols should consider the optimal timing of baseline creatinine and the limitations of using a baseline creatinine during an acute illness.

Original languageEnglish
Pages (from-to)100 - 104
Number of pages5
JournalNephrology
Volume29
Issue number2
Early online date2023
DOIs
Publication statusPublished - Feb 2024

Bibliographical note

Funding Information:
The CAMERA2 Study Group and collaborating authors: Steven Y. C. Tong, David C. Lye, Dafna Yahav, Archana Sud, J. Owen Robinson, Jane Nelson, Sophia Archuleta, Matthew A. Roberts, Alan Cass, David L. Paterson, Hong Foo, Mical Paul, Stephen D. Guy, Adrian R. Tramontana, Genevieve B. Walls, Stephen McBride, Narin Bak, Niladri Ghosh, Benjamin A. Rogers, Anna P. Ralph, Jane Davies, Patricia E. Ferguson, Ravindra Dotel, Genevieve L. McKew, Timothy J. Gray, Natasha E. Holmes, Simon Smith, Morgyn S. Warner, Shirin Kalimuddin, Barnaby E. Young, Naomi Runnegar, David N. Andresen, Nicholas A. Anagnostou, Sandra A. Johnson, Mark D. Chatfield, Allen C. Cheng, Vance G. Fowler Jr, Benjamin P. Howden, Niamh Meagher, David J. Price, Sebastiaan J. van Hal, Satinder Gill, Alexander Rofe, Matthew V. N. O'Sullivan, Niamh Meagher, Vered Daitch, Yael Dishon‐Benattar, Chen Xinxin, Yei He Ping, Russel Lee, Hong Foo, Adelaide Grenfell, Ying Li, Kellie Schneider, Timothy Chia, Christina Titin, Joshua S. Davis. The CAMERA2 trial was supported by Australian National Health & Medical Research Council Career Development Fellowships for S. Y. C. T. (1145033) and J. S. D. (1160331). J.A. Roberts would like to acknowledge funding from the Australian National Health and Medical Research Council for a Centre of Research Excellence (APP2007007) and an Investigator Grant (APP2009736) as well as an Advancing Queensland Clinical Fellowship. Open access publishing facilitated by Charles Darwin University, as part of the Wiley ? Charles Darwin University agreement via the Council of Australian University Librarians.

Publisher Copyright:
© 2023 The Authors. Nephrology published by John Wiley & Sons Australia, Ltd on behalf of Asian Pacific Society of Nephrology.

Fingerprint

Dive into the research topics of 'Avoiding misclassification of acute kidney injury: Timing is everything'. Together they form a unique fingerprint.

Cite this