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

NCT ID: NCT05161078

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-16

Study Completion Date

2031-12-31

Brief Summary

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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

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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.

Conditions

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Acute Kidney Injury Chronic Kidney Diseases Renal Dialysis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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All Patients Enrolled

Patients will be treated with CARPEDIEM per standard of care.

CARPEDIEM

Intervention Type DEVICE

CARPEDIEM treatment as per local standard of care

Interventions

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CARPEDIEM

CARPEDIEM treatment as per local standard of care

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mozarc Medical US LLC

INDUSTRY

Sponsor Role collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cara Slagle, MD

Role: PRINCIPAL_INVESTIGATOR

Cincinnati Children's

Locations

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Lucile Salter Packard Children's Hospital at Stanford

Palo Alto, California, United States

Site Status

Children's Hospital Colorado

Aurora, Colorado, United States

Site Status

Children's Hospital of Atlanta

Atlanta, Georgia, United States

Site Status

C.S. Mott Children's Hospital

Ann Arbor, Michigan, United States

Site Status

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Texas Children's Hospital

Houston, Texas, United States

Site Status

Seattle Children's

Seattle, Washington, United States

Site Status

The Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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ICONIIC

Identifier Type: -

Identifier Source: org_study_id