ICONIC: Improving Carpediem Outcomes in Neonates and Infants Through Collaboration

• Conditions: Chronic Kidney Diseases; Acute Kidney Injury; Renal Dialysis
• Interventions: Device: CARPEDIEM

• Registration Number: NCT05161078
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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 Timeline

• Study First Submitted: 2021-11-23
• Study First Submitted QC: 2021-12-06
• Study Start: 2021-12-16
• Study First Posted: 2021-12-16
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-12
• Primary Completion: 2027-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Patients Enrolled	CARPEDIEM	Patients will be treated with CARPEDIEM per standard of care.

Primary Outcome Measures

Name	Time	Method
Number of CARPEDIEM filters to meet prescribed treatment length	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	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	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.

Trial Locations

Locations (9)

The Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

Lucile Salter Packard Children's Hospital at Stanford; 🇺🇸 Palo Alto, California, United States

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States

Children's Hospital of Atlanta; 🇺🇸 Atlanta, Georgia, United States

C.S. Mott Children's Hospital; 🇺🇸 Ann Arbor, Michigan, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, 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, United States