ICONIC: Improving Carpediem Outcomes in Neonates and Infants Through Collaboration

Acute Kidney Injury Clinical Trial

— ICONIC  

Official title:

Improving Carpediem Outcomes in Neonates and Infants Through Collaboration

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05161078
• Other study ID #: CIN001 - ICONIC
• Status: Enrolling by invitation
• Start date: December 16, 2021
• Est. completion date: December 31, 2029

Study information

• Verified date: May 2024
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Chronic Kidney Diseases
• Kidney Diseases
• Renal Dialysis
• Renal Insufficiency, Chronic

Intervention

Device:
• CARPEDIEM
CARPEDIEM treatment as per local standard of care

Locations

Country	Name	City	State
United States	C.S. Mott Children's Hospital	Ann Arbor	Michigan
United States	Children's Hospital of Atlanta	Atlanta	Georgia
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Texas Children's Hospital	Houston	Texas
United States	Seattle Children's	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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