Trials / Enrolling By Invitation
Enrolling By InvitationNCT05161078
Improving Continuous Renal Replacement Therapy Outcomes in Neonates and Infants Through Interdisciplinary Collaboration
Improving Continuous Renal Replacement Therapy (CCRT) Outcomes in Neonates and Infants Through Interdisciplinary Collaboration
- Status
- Enrolling By Invitation
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,000 (estimated)
- Sponsor
- Children's Hospital Medical Center, Cincinnati · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CARPEDIEM | CARPEDIEM treatment as per local standard of care |
Timeline
- Start date
- 2021-12-16
- Primary completion
- 2027-12-31
- Completion
- 2031-12-31
- First posted
- 2021-12-16
- Last updated
- 2026-03-23
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05161078. Inclusion in this directory is not an endorsement.