To date, little knowledge exists related to the use of hemodialysis (HD) in infants and has been limited to mainly single center studies. The CARPEDIEM (CArdio-Renal PEdiatric Dialysis Emergency Machine) device, which can be used to provide hemodialysis in infants, has been launched in the United States. This study/registry is designed to obtain data on critically ill infants who require HD using the CARPEDIEM device to understand the indications for initiation, best practice in prescribing and performing treatment, expected treatment course, and outcomes of a dedicated infant continuous renal replacement therapy (CRRT) machine.
This is a retrospective and prospective, multicenter observational quality improvement study and research registry. Infants undergoing renal replacement therapy utilizing CARPEDIEM for hemodialysis will be enrolled in the study for observation. There are two arms to this study, one for quality improvement and one for research purposes. Patients enrolled in this study have the option to participate additionally in either biospecimen collection, long term follow up after CARPEDIEM, or both. Urine specimen will be collected from fresh voids, but all blood specimen will be obtained from residual clinical specimen. Investigators hope to gain more information into use, treatment course, and outcomes from infants requiring treatment with the CARPEDIEM device.
Study Type
OBSERVATIONAL
Enrollment
1,000
CARPEDIEM treatment as per local standard of care
Lucile Salter Packard Children's Hospital at Stanford
Palo Alto, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Children's Hospital of Atlanta
Atlanta, Georgia, United States
C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Texas Children's Hospital
Houston, Texas, United States
Seattle Children's
Seattle, Washington, United States
The Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Number of CARPEDIEM filters to meet prescribed treatment length
Comparing actual time of treatment of each CARPEDIEM filter to the initial prescribed length of treatment at the time of filter initiation
Time frame: 24 hours
Rate of patient survival
Percent of patients treated with the CARPEDIEM who survive to hospital discharge
Time frame: through hospital discharge, an average of less than 1 year
Rate of renal recovery
Excluding patients with End Stage Renal Disease (ESRD), percent of patients treated with the CARPEDIEM who recover baseline renal function as measured by liberation from dialysis and serum creatinine returning to within less than a 50% increase over baseline.
Time frame: through hospital discharge, an average of less than 1 year
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