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

Last updated: December 9, 2024
Sponsor: Children's Hospital Medical Center, Cincinnati
Overall Status: Active - Enrolling

Phase

N/A

Condition

Hemodialysis

Kidney Disease

Renal Failure

Treatment

CARPEDIEM

Clinical Study ID

NCT05161078
ICONIIC
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: CARPEDIEM
Phase:
Study Start date:
December 16, 2021
Estimated Completion Date:
December 31, 2031

Study 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.

Connect with a study center

  • Lucile Salter Packard Children's Hospital at Stanford

    Palo Alto, California 94304
    United States

    Site Not Available

  • Children's Hospital Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Children's Hospital of Atlanta

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • C.S. Mott Children's Hospital

    Ann Arbor, Michigan 48103
    United States

    Site Not Available

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Texas Children's Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • Seattle Children's

    Seattle, Washington 98105
    United States

    Site Not Available

  • The Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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