Improving Continuous Renal Replacement Therapy Outcomes in Neonates and Infants Through Interdisciplinary Collaboration
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CARPEDIEM.
- Who it may be relevant to
- Registry conditions: Acute Kidney Injury, Chronic Kidney Diseases, Renal Dialysis. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Improving Continuous Renal Replacement Therapy (CCRT) Outcomes in Neonates and Infants Through Interdisciplinary Collaboration
Overview
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
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.
Interventions
- Device CARPEDIEM
CARPEDIEM treatment as per local standard of care
Primary outcome measures
- Number of CARPEDIEM filters to meet prescribed treatment length [Time frame: 24 hours]
- Rate of patient survival [Time frame: through hospital discharge, an average of less than 1 year]
- Rate of renal recovery [Time frame: through hospital discharge, an average of less than 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 9 centers
- Lucile Salter Packard Children's Hospital at Stanford — Palo Alto
- Children's Hospital Colorado — Aurora
- Children's Hospital of Atlanta — Atlanta
- C.S. Mott Children's Hospital — Ann Arbor
- University of Nebraska Medical Center — Omaha
- Cincinnati Children's Hospital Medical Center — Cincinnati
- Texas Children's Hospital — Houston
- Seattle Children's — Seattle
- … and 1 more center
Publications
- 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.2025.1 PMID 41016463
Identifiers
NCT: NCT05161078 · ICONIIC