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Cincinnati Children’s One of Nine Sites in Nation Selected for Pediatric Heart Network

Tuesday, October 11, 2011

Cincinnati Children’s Hospital Medical Center has been selected as one of only nine Pediatric Heart Network (PHN) core sites in North America.

Created and funded in 2001 by the National Heart, Lung and Blood Institute, part of the National Institutes of Health, the PHN is a collaborative network of pediatric cardiovascular centers that conduct clinical studies in children with congenital or acquired heart disease.

In the past 25 years, fewer than 40 randomized clinical trials have been done in patients with congenital or acquired heart disease. This is often because many hospitals or doctors do not see enough children with any one type of heart disease to perform certain studies and have meaningful results. In addition, parents have been unable to enter their children into studies because they are not aware of them or don’t live near a research site.

The PHN has completed nine studies since 2001. PHN centers collaborate on studies to increase the total number of patients enrolled in each study, improving the likelihood of meaningful results. When studies need more patients than the core centers have, other skilled centers may be added as ancillary sites.

Cincinnati Children’s has been a member of the network since 2006. Its successful renewal this year is due to a strong research infrastructure within the Heart Institute, experienced investigators and a novel research proposal to study acute kidney injury following cardiopulmonary bypass.

Up to 40 percent of adults and children who have cardiac surgery develop acute kidney injury (AKI), often with deadly consequences. That’s partially because it takes several days to determine if the test used to diagnose is abnormal – too late to prevent kidney failure.

The best test for kidney injury currently available measures creatinine, a waste product. A high level of creatinine in the blood means the kidney is unable to filter out the chemical. The standard of care if to wait until creatinine rises before diagnosing and treating AKI. Unfortunately, it may take days for the creatinine level to rise after the kidney is injured. By the time the creatinine test shows kidney injury, the child or adult may already have lost up to 50 percent of kidney function.

Because of the urgent need for a better diagnostic tool, Prasad Devarajan, MD, director of Nephrology and Hypertension at Cincinnati Children’s, went to the laboratory and discovered that NGAL, a protein activated when the kidney is injured, was a useful biomarker of AKI. A biomarker is a protein measured in blood or urine whose concentration reflects the severity or presence of a disease state.

To test this biomarker in humans, Dr. Devarajan collaborated with Catherine Krawczeski, MD, a pediatric cardiologist in the Cincinnati Children’s Heart Institute to, study kidney injury in children after cardiopulmonary bypass. Together, they found that NGAL levels rise in blood and urine within two hours of the start of heart-lung bypass, allowing physicians to pinpoint timing of kidney injury and initiate therapy earlier than ever before.

To build on this research, Cincinnati Children’s established the Center for Acute Care Nephrology in 2010. This center brings together a unique team: nephrologists who are pioneering leaders in laboratory and clinical research, working in an unusually collaborative relationship with experts in cardiac and pediatric intensive care. The center is directed by Stuart Goldstein, MD.

The team is now ready to use this diagnostic tool to identify children with very early kidney injury and study treatments that may reverse the injury or halt its progression.

As part of the PHN, Cincinnati Children’s has proposed studying whether early treatment of acute kidney injury with sodium bicarbonate and N-acetylcysteine, an antioxidant, will improve outcomes following cardiopulmonary bypass.

To conduct this study, Cincinnati Children’s has joined with Riley Children’s Hospital in Indianapolis to form the Prairieland Consortium. D. Woodrow Benson, MD, PhD, James Cnota, MD, and Catherine Krawczeski, MD, all at the Cincinnati Children’s Heart Institute, will serve as principal investigators. R. Mark Payne, MD, will be principal investigator at Riley Children’s Hospital.

About Cincinnati Children's

Cincinnati Children's Hospital Medical Center ranks third in the nation among all Honor Roll hospitals in U.S. News and World Report's 2011 Best Children's Hospitals ranking. It is ranked #1 for gastroenterology and in the top 10 for all pediatric specialties - a distinction shared by only two other pediatric hospitals in the United States. Cincinnati Children's is one of the top two recipients of pediatric research grants from the National Institutes of Health. It is internationally recognized for improving child health and transforming delivery of care through fully integrated, globally recognized research, education and innovation. Additional information can be found at www.cincinnatichildrens.org.