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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CARPEDIEM

Device

CARPEDIEM treatment as per local standard of care

Primary outcomes

Number of CARPEDIEM filters to meet prescribed treatment length

Time frame: 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

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

Mozarc Medical US LLC

Registry information

Official study title

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

Acronym: ICONIIC

Important dates

Study start: 2021
Primary completion: 2027
Study completion: 2031
First posted: Dec 16, 2021
Registry last updated: Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed