ICONIC: Improving Carpediem Outcomes in Neonates and Infants Through Collaboration

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Improving Carpediem Outcomes in Neonates and Infants Through Collaboration

Conditions
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Acute Kidney Injury, Chronic Kidney Diseases, Renal Dialysis

Intervention / Treatment
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* Device: CARPEDIEM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Treated with CARPEDIEM as part of standard of care at a participating institution within the United States Exclusion Criteria: Parents/legally authorized representative unable or unwilling to provide consent
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All Patients Enrolled<br>Patients will be treated with CARPEDIEM per standard of care. | Device: CARPEDIEM<br>* CARPEDIEM treatment as per local standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 24 hours | 
| Rate of patient survival | Percent of patients treated with the CARPEDIEM who survive to hospital discharge | 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. | through hospital discharge, an average of less than 1 year |