Legg, Amy

Roberts, Jason A

Roberts, Matthew A

Cass, Alan

Davies, Jane

Tong, Steven Y C

Davis, Joshua S

2023-10-11

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.

Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.

Herston Infectious Diseases Institute, Metro North Health, Brisbane, Queensland, Australia.

Faculty of Medicine, University of Queensland Centre for Clinical Research (UQCCR), Brisbane, Queensland, Australia.

Departments of Intensive Care Medicine and Pharmacy, Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.

Nîmes University Hospital, Division of Anaesthesiology Critical Care Emergency and Pain Medicine, University of Montpellier, Nîmes, France.

Eastern Health Clinical School, Monash University, Box Hill, Victoria, Australia.

Department of Infectious Diseases, Royal Darwin Hospital, Darwin, Northern Territory, Australia.

Victorian Infectious Diseases Service, The Royal Melbourne Hospital, Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.

Department of Infectious Diseases, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Australia.

School of Medicine and Public Health, The University of Newcastle, Newcastle, New South Wales, Australia.

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

Nephrology (Carlton). 2023 Oct 11. doi: 10.1111/nep.14246.

0000-0001-8228-1536

0000-0003-1665-3455

0000-0001-9864-5699

https://pubmed.ncbi.nlm.nih.gov/37820650/?otool=iaurydwlib

https://hdl.handle.net/10137/12608

Avoiding misclassification of acute kidney injury: Timing is everything.

Journal Article

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