Improving Continuous Renal Replacement Therapy (CCRT) Outcomes in Neonates and Infants Through Interdisciplinary Collaboration
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Enrollment
- 1,000
- Locations
- 9
- Primary Endpoint
- Number of CARPEDIEM filters to meet prescribed treatment length
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Number of CARPEDIEM filters to meet prescribed treatment length
Time Frame: 24 hours
Comparing actual time of treatment of each CARPEDIEM filter to the initial prescribed length of treatment at the time of filter initiation
Rate of patient survival
Time Frame: through hospital discharge, an average of less than 1 year
Percent of patients treated with the CARPEDIEM who survive to hospital discharge
Rate of renal recovery
Time Frame: through hospital discharge, an average of less than 1 year
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.
Secondary Outcomes
No secondary outcomes reported