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The research was presented by Prasad Devarajan, M.D., director ofnephrology and hypertension, Cincinnati Children's Hospital Medical Center, ata scientific workshop hosted by Abbott.
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AKI is a common and potentially devastating illness in hospitalizedpatients. Onset is rapid and can result from trauma, sepsis or administrationof medications toxic to the kidneys. AKI can also present followingcardiothoracic surgery or as a complication of diabetes and other chronicconditions. AKI quickly reduces the ability of the kidneys to filter wasteand leads to renal failure. Many patients with a severe form of AKI faceextensive time on dialysis. The mortality rate for patients with AKI ranges upto more than 80 percent in post-operative settings, according to a studyreported recently in the Annals of Internal Medicine.
"Unfortunately, the current testing procedure for AKI -- a blood test tomeasure the ability of the kidneys to filter creatinine into the urine -- isunable to identify the problem in the first 48 hours when time is critical forpreventing kidney failure," said Dr. Devarajan. "The incidence of this commoncomplication has risen by 11 percent in recent years, and we need better waysto diagnose and treat the condition and lower the risk of death or needingdialysis," he said.
Devarajan reported today the results of clinical studies conducted for anew diagnostic biomarker for acute AKI, called urine NGAL (neutrophilgelatinase-associated lipocalin). The protein is produced by the kidneytubules and appears in urine just two to four hours following AKI, up to 46hours sooner than biomarkers detected by current testing methods.
"The urine NGAL marker has the potential to represent a major advance inidentifying patients at risk for developing AKI after surgery or trauma and inother situations commonly seen in critically ill patients," Devarajan said.He noted that delayed diagnosis of AKI with currently-used creatinine testsmay prevent physicians from using hydration or blood pressure support in atimely manner to lower the risk for patient harm.
The costs of AKI are a substantial $10 billion a year, mainly from lengthyhospital stays and expensive interventions, according to Chirag Parikh, M.D.,Ph.D., associate professor of medicine, Yale University Medical School. "Serumcreatinine testing is inadequate. It is a non-specific marker that delaysdiagnosis of AKI. New biomarkers are needed to stimulate testing of newtherapies and significantly decrease the mortality in AKI and costs associatedwith it," he said.
In his research, Devarajan analyzed urine samples from children withcongenital heart defects who had cardiopulmonary bypass surgery. Theprocedure is a major risk factor for AKI. Half of the children developed AKI,based on results of creatinine tests reported two to three days after surgery.However, their NGAL levels began to increase within a few hours. "Rises inurine NGAL levels at two hours identified 90 percent of children who laterdeveloped AKI. Urine NGAL, therefore, was highly predictive of AKI risk, andwe found those with higher levels were more likely to die or need dialysis,"Devarajan said. He added that these findings have been confirmed in adultpopulations.
About 65 percent of patients with the highest increase in urine NGAL willrequire immediate care by a nephrologist and a third will go on dialysis."Clinically, there is no comparison since NGAL provides specific and rapiddiagnosis of AKI while creatinine blood tests are not able to distinguish AK
