An analysis of patients in the emergency department at a hospital in Germany found that using the NephroCheck Test could help identify the risk of acute kidney injury in patients with acute decompensated heart failure.
The results were published online in Clinical Cardiology on March 10.
The Robert-Bosch Foundation in Stuggart, Germany, and Astute Medical, which manufactures and markets the NephroCheck Test, funded the study.
In 2014, the FDA approved the laboratory test help determine if certain critically ill hospitalized patients are at risk of developing moderate to severe acute kidney injury in the 12 hours following test administration.
For this study, the researchers enrolled 400 patients in the emergency department at Robert-Bosch Hospital. They evaluated the capabilities of TIMP-2 and IGFBP7, the two urinary biomarkers that the test measures. They were interested in testing the predictive ability of those biomarkers for developing stage 2 or 3 acute kidney injury within 24 hours of collecting samples in patients with acute decompensated heart failure.
Of the patients, 40 had acute decompensated heart failure and sufficient data for acute kidney injury staging, according to the researchers. Of those 40 patients, 11 developed acute kidney injury within seven days.
The researchers found that the urinary biomarkers discriminated for stage 2 or 3 acute kidney injury with an area under the curve of 0.84 within 24 hours of presentation and 0.77 for samples collected within seven days. They added that on the first day, the sensitivity was 86 percent at the 0.3 cutoff and the specificity was 95 percent at the 2.0 cutoff for predicting stage 2 or 3 acute kidney injury.
In addition, they noted that Kaplan-Meier curves showed a trend for decreased survival for a year in patients who reached stage 2 or 3 acute kidney injury within seven days compared with those who did not reach that point. They also said the study’s main limitation was its small sample size and recommended larger studies were necessary to confirm the results.
“Physicians are looking forward to the widespread use of a test that can detect [acute kidney injury] long before the rise of serum creatinine and allow doctors an opportunity to adjust medications and provide more effective therapy for this important patient population,” Peter A. McCullough, M., MPH, president of the Cardio Renal Society of America, said in a news release.