Classification of Acute Kidney Injury in Clinical Trials

By Victoria Socha - Last Updated: April 2, 2024

According to Amy Legg and colleagues, accurate detection of acute kidney injury (AKI) in clinical trials is important. However, using a baseline creatinine measurement from trial enrollment may not provide a true measurement of a participant’s baseline kidney function.

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The researchers conducted an analysis of data from the CAMERA2 (Combination Antibiotic Therapy for Methicillin-Resistant Staphylococcus aureus) randomized trial. The analysis was designed to determine whether a pretrial baseline creatinine level resulted in comparable creatinine concentrations with a trial baseline creatinine. The researchers also examined the timing of baseline creatinine and the incidence of AKI. They reported their results in the journal Nephrology.

CAMERA2 study sites retrospectively collected pretrial baseline creatinine from up to 1 year prior to enrollment when the patient was medically stable. Trial baseline creatinine was the highest creatinine measurement in the 24 hours preceding randomization.

In the current analysis, pretrial and trial baseline creatinine concentrations were compared using the Wilcoxon sign rank test. The researchers analyzed data from 217 patients.

Median pretrial baseline creatinine was significantly lower than the median trial baseline creatinine (82 µmol/L vs 86 µmol/L; P<.001). Using pretrial baseline creatinine measurements, 22% (n=48/217) met the criteria for AKI at enrollment in CAMERA2; only five of those patients met criteria for AKI using CAMERA2 study protocol (using baseline creatinine from trial entry).

In conclusion, the authors said, “Using a baseline creatinine from the time of trial enrollment 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.”

Source: Nephrology

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