Improving Continuous Renal Replacement Therapy Outcomes in Neonates and Infants Through Interdisciplinary Collaboration

NCT05161078 | Enrolling By Invitation FDA Device

• 1 other identifier: ICONIIC
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 9

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.

Conditions

Chronic Kidney Diseases; Renal Dialysis; Acute Kidney Injury

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

All Patients Enrolled

Patients will be treated with CARPEDIEM per standard of care.

Device: CARPEDIEM

Interventions

CARPEDIEM DEVICE

CARPEDIEM treatment as per local standard of care

All Patients Enrolled

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with CARPEDIEM as part of standard of care at a participating institution's Neonatal Intensive Care Unit (NICU), Cardiac Intensive Care Unit (CICU), or Pediatric Intensive Care Unit (PICU).

You may qualify if:

• Treated with CARPEDIEM as part of standard of care at a participating institution within the United States

You may not qualify if:

• Parents/legally authorized representative unable or unwilling to provide consent

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Mozarc Medical US LLC: collaborator

Study Sites (9)

Lucile Salter Packard Children's Hospital at Stanford

Palo Alto, California, 94304, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Children's Hospital of Atlanta

Atlanta, Georgia, 30322, United States

Location

C.S. Mott Children's Hospital

Ann Arbor, Michigan, 48103, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Seattle Children's

Seattle, Washington, 98105, United States

Location

The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• 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.2025.114838. Epub 2025 Sep 26.

  PMID: 41016463 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine will be collected via natural void or collected in some other manner if ordered per standard of care. Blood specimen will be obtained from residual clinical specimen only. All specimen will be stored for future unspecified research at Cincinnati Children's.

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cara Slagle, MD

  Cincinnati Children's

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 16, 2021
• Study Start: December 16, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2031
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

US (9)