The registry will include data on ultrafiltration utility, performance, and safety profile in pediatric patients from approximately ten research institutions over an anticipated time period of two and a half years. The parties anticipate collecting data on up to 500 patients, and the registry is expected to be operational by the end of this year.
“Fluid overload is associated with increased mortality and adverse outcomes in pediatric patients. Improving our understanding of ultrafiltration performance in clinical conditions, such as cardiac or renal diseases, will be critically important to effectively inform our treatment strategies,” said Dr. Stuart Goldstein, M.D., professor of Pediatrics and director, Center for Acute Care Nephrology at Cincinnati Children’s Hospital Medical Center and chairman of the Acute Kidney Injury Critical Care Research Foundation. “To date there has not been a large prospective multicenter evaluation of the use of the Aquadex system in pediatric patients. We expect this registry to expand knowledge about fluid overload to help healthcare providers determine the best solutions available for their patients.”
“CHF Solutions is committed to supporting the collection of robust and current clinical data to allow medical professionals to make well-informed treatment decisions on behalf of their patients,” said John Erb, CEO of CHF Solutions. “We believe that this investment will lead to a broad database of important clinical information to support life-saving interventions to treat fluid overload in pediatric patients.”
Fluid overload (hypervolemia), which occurs when there is too much fluid in the body, is a major issue among critically ill children and adults, and when left untreated, it can lead to life-threatening consequences. Available therapies require very high relative extracorporeal blood volumes, which can be challenging for pediatric patients. In a retrospective, multi-center study, 32 critically ill pediatric patients weighing over 20 kgs and predominantly suffering from hypervolemia were treated with the Aquadex FlexFlow System and 97 percent (31/32) survived to the end of therapy.1
The Aquadex SmartFlow system delivers clinically proven therapy using a simple, flexible and smart method of removing excess fluid from patients suffering from hypervolemia (fluid overload). The Aquadex SmartFlow system is indicated for temporary (up to eight hours) or extended (longer than eight hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kg or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a healthcare provider, within an outpatient or inpatient clinical setting, under physician prescription, both having received training in extracorporeal therapies.