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| Name | Class |
|---|---|
| Mozarc Medical US LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Patients Enrolled | Patients will be treated with CARPEDIEM per standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CARPEDIEM | Device | CARPEDIEM treatment as per local standard of care |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated with CARPEDIEM as part of standard of care at a participating institution's Neonatal Intensive Care Unit (NICU), Cardiac Intensive Care Unit (CICU), or Pediatric Intensive Care Unit (PICU).
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| Name | Affiliation | Role |
|---|---|---|
| Cara Slagle, MD | Cincinnati Children's | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucile Salter Packard Children's Hospital at Stanford | Palo Alto | California | 94304 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41016463 | Derived | Slagle CL, Vuong KT, Krallman KA, Casey L, Gist KM, Jetton JG, Joseph C, Luckritz K, Martin SD, Morgan J, Merrill KA, Plomaritas K, Ramirez D, Tran CL, Shin HS, Snyder AN, Van Wyk B, Yalon L, Goldstein SL, Menon S. Infant Renal Replacement Therapy Using Carpediem: A Multicenter Observational Cohort Study from the ICONIIC Learning Network. J Pediatr. 2026 Jan;288:114838. doi: 10.1016/j.jpeds.2025.114838. Epub 2025 Sep 26. |
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Urine will be collected via natural void or collected in some other manner if ordered per standard of care. Blood specimen will be obtained from residual clinical specimen only. All specimen will be stored for future unspecified research at Cincinnati Children's.
| Children's Hospital Colorado |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Children's Hospital of Atlanta | Atlanta | Georgia | 30322 | United States |
| C.S. Mott Children's Hospital | Ann Arbor | Michigan | 48103 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| Seattle Children's | Seattle | Washington | 98105 | United States |
| The Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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