Acute Kidney InjuryICONIICNCT05161078
Improving Continuous Renal Replacement Therapy Outcomes in Neonates and Infants Through Interdisciplinary Collaboration
An observational study of Acute Kidney Injury and Chronic Kidney Diseases, run by Children's Hospital Medical Center, Cincinnati at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Kidney Injury, Chronic Kidney Diseases, Renal Dialysis
- What is being tested?
- CARPEDIEM
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 9 sitesUnited States
- Study dates
- 16 Dec 2021to 31 Dec 2031
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- Treated with CARPEDIEM as part of standard of care at a participating institution within the United States
Who cannot join
- Parents/legally authorized representative unable or unwilling to provide consent
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites
C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48103
Children's Hospital of Atlanta
Atlanta, Georgia, 30322
Children's Hospital Colorado
Aurora, Colorado, 80045
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Texas Children's Hospital
Houston, Texas, 77030
The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Lucile Salter Packard Children's Hospital at Stanford
Palo Alto, California, 94304
Seattle Children's
Seattle, Washington, 98105
About this study
Official title: Improving Continuous Renal Replacement Therapy (CCRT) 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.
Read the detailed 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.
- Conditions
- Acute Kidney Injury, Chronic Kidney Diseases, Renal Dialysis
- Being tested
- CARPEDIEM
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARPEDIEMDevice
CARPEDIEM treatment as per local standard of care
| Study group | Role | What they receive |
|---|---|---|
| All Patients Enrolled | Patients will be treated with CARPEDIEM per standard of care. Receives: Device: CARPEDIEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Rate of patient survival
Percent of patients treated with the CARPEDIEM who survive to hospital discharge
Measured: 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.
Measured: through hospital discharge, an average of less than 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start16 Dec 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Mozarc Medical US LLC
- Responsible party
- Sponsor
- Investigators
- Cara Slagle, MD, Principal investigator, Cincinnati Children's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161078
- Sponsor's protocol ID
- ICONIIC
- Acronym
- ICONIIC
- Status last verified
- Mar 2026
- First submitted
- 23 Nov 2021
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 41016463
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Continuous Renal Replacement Therapy (CCRT) Outcomes in Neonates and Infants Through Interdisciplinary Collaboration
- ClinicalTrials.gov ID
- NCT05161078
- Acronym / sponsor ID
- ICONIIC / ICONIIC
- Conditions
- Acute Kidney Injury, Chronic Kidney Diseases, Renal Dialysis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Mozarc Medical US LLC
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 4 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Patients Enrolled | – | Device: CARPEDIEMPatients will be treated with CARPEDIEM per standard of care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- Treated with CARPEDIEM as part of standard of care at a participating institution within the United States
Key exclusion criteria (1 listed)
- Parents/legally authorized representative unable or unwilling to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CARPEDIEMCARPEDIEM treatment as per local standard of care | Device | All Patients Enrolled |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Derived from this study: PubMed 41016463Slagle 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cara Slagle, MD principal investigator
Cincinnati Children's
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Chronic Kidney Diseases, run by Children's Hospital Medical Center, Cincinnati at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of CARPEDIEM filters to meet prescribed treatment length (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05161078, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.