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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT05161078
Status
Enrolling By Invitation

Conditions

  • Acute Kidney Injury
  • Chronic Kidney Diseases
  • Renal Dialysis

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • CARPEDIEM — DEVICE
    CARPEDIEM treatment as per local standard of care

Study Details

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.

Key Dates

Start date
Dec 16, 2021
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2031

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: All Patients Enrolled
    Patients will be treated with CARPEDIEM per standard of care.

Primary Outcome Measure

Number of CARPEDIEM filters to meet prescribed treatment length [ Time Frame: 24 hours ]

Locations (9)

FacilityCityStateZIPSite coordinators
Lucile Salter Packard Children's Hospital at StanfordPalo AltoCalifornia94304-
Children's Hospital ColoradoAuroraColorado80045-
Children's Hospital of AtlantaAtlantaGeorgia30322-
C.S. Mott Children's HospitalAnn ArborMichigan48103-
University of Nebraska Medical CenterOmahaNebraska68198-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
Texas Children's HospitalHoustonTexas77030-
Seattle Children'sSeattleWashington98105-
The Medical College of WisconsinMilwaukeeWisconsin53226-

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By research site
Lucile Salter Packard Children's Hospital at Stanford· Palo Alto, CAChildren's Hospital Colorado· Aurora, COChildren's Hospital of Atlanta· Atlanta, GAC.S. Mott Children's Hospital· Ann Arbor, MIUniversity of Nebraska Medical Center· Omaha, NECincinnati Children's Hospital Medical Center· Cincinnati, OH

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