Study Shows Improved Outcomes With NephroCheck Test For Risk Assessment Of Acute Kidney Injury And KDIGO Intervention - Seite 2

"The faster you can identify patients at low risk or high risk the quicker you can get them into the (treatment) pathway that is necessary," said Dr. Kellum, who was the lead investigator in the FDA clinical trial for the clearance of the NephroCheck Test.

Up to one-third of patients undergoing cardiac surgery develop some form of AKI,[5] which can increase the length of stay in the intensive care unit by up to three times and inflate the cost of treatment.³ When AKI is severe enough to require dialysis, mortality rates soar to 50 to 90 percent, compared to a mortality rate of less than 3 percent for patients who do not develop AKI.³

The study details a randomized control trial led by Alexander Zarbock, M.D., at University Hospital Muenster, Germany, a 1,300-bed facility with expertise in cardiac and vascular medicine. Clinicians used the NephroCheck Test to measure TIMP-2 and IGFBP-7 four hours after patients had coronary artery bypass surgery. The 276 trial participants who were NephroCheck Test-positive for being at risk of developing moderate to severe AKI (NephroCheck AKIRisk Score of >0.3) were randomized into either a control group, which received the institution's standard care, or to an intervention group, which received treatment per KDIGO guidelines.

Treatment of the intervention group included avoidance of nephrotoxic medications and close hemodynamic monitoring of heart function and blood pressure parameters in conjunction with use of intravenous fluids and vasoactive drug, in order to avoid organ damage.

The result was that within 72 hours there were 21 fewer cases of moderate to severe AKI in the intervention group than in the control group (41 cases in the intervention group compared to 62 in the control group), a 33.9 percent reduction. The absolute risk reduction rate was 15.2 percent when intervention was applied.

"It's notable that these significant results were achieved in a study enrolling all types of open-heart surgery patients, regardless of co-morbidities, yet risk assessment was not compromised," said Paul McPherson, Ph.D., Astute Medical's chief scientific officer. "Additionally, the intervention group was managed per consensus guidelines with treatments that are accessible to all physicians who manage these types of patients," McPherson said.