Acute Kidney InjuryNCT04608149
Prospective, Multi-center, Single-arm, Observational Study. US FDA 522 Pediatric Post Market Surveillance Study.
An observational study of Acute Kidney Injury and Fluid Overload, run by Mozarc Medical US LLC at 6 sites in United States.
Trial summary
The post market surveillance study will employ a prospective, multi-center, single-arm, observational design to capture data on children who undergo CRRT using the Carpediem™ system. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Kidney Injury, Fluid Overload
- What is being tested?
- Carpediem System
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 6 sitesUnited States
- Study dates
- 20 Jan 2021to 30 Apr 2026
- How long will I take part?
- 120 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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 who have acute kidney injury or fluid overload requiring hemodialysis or hemofiltration who weigh between 2.5 and 10 kilograms (5.5 to 22 pounds).
Who may be able to join
- Parent or LAR has signed information consent
- Subject weighs between 2.5-10 kg (or 5.5-22 lbs)
- Subject is receiving medical care in an intensive care unit
- Parental or LAR consent to receive full supportive care through aggressive management utilizing all available therapies for a minimum of 96 hours
- Subject has a clinical diagnosis of acute kidney injury per Kidney Disease Improving Global Outcomes (KDIGO) criteria or fluid overload requiring CRRT
Who cannot join
- Subject is not expected to survive 72 hours due to an irreversible medical condition, in the opinion of the investigator
- Subject has irreversible brain damage, in the opinion of the investigator
- Subject is intolerant to anticoagulation, as documented in the medical record
- Subject has a Do Not Attempt Resuscitate (DNAR), Allow Natural Death (AND), withdrawal of care or similar order, or anticipated change in status, in the opinion of the investigator, within the next 7 days
- Subject has pre-existing end-stage renal disease or pre-existing, advanced chronic kidney disease, defined as an estimated Glomerular Filtration Rate (eGRF) < 30 ml/min/1.73m2
- Subject is currently or has chronically been treated with a circulatory support device (i.e., left ventricular assist device (LVAD)) other than ECMO
Show all 9Show fewer
- Subject has had prior CRRT treatments using the Carpediem™ system
- Subject is enrolled in clinical trials or being treated with other investigational therapeutic devices or products for acute kidney injury or fluid overload
- Subject has any other medical condition that may confound the study objectives, in the opinion of the investigator
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Texas Children's Hospital
Houston, Texas, 77030
University of Iowa Healthcare
Iowa City, Iowa, 52252
Mayo Clinic
Rochester, Minnesota, 55905
Golisano Children's Hospital
Rochester, New York, 14642
Seattle Children's
Seattle, Washington, 98103
About this study
Official title: Carpediem(TM) Post Market Surveillance Study
The post market surveillance study will employ a prospective, multi-center, single-arm, observational design to capture data on children who undergo CRRT using the Carpediem™ system. Participating clinicians will manage subjects in accordance to their local standard of care practices and decisions on initiating, modifying or discontinuing CRRT are up to the local investigative team's prescription.
A minimum of 10 centers in the United States, that have been trained on the use of the Carpediem™ system, will be invited to participate in the study. After obtaining institutional review board approval and written informed consent from a parent or legally authorized representative (LAR), data from all subjects treated with the Carpediem™ system will be included in the study. A minimum of 35 subjects will be enrolled and sites may be asked to screen and enroll patients for the study for up to 36 months.
Status of subjects discharged from hospital will be collected at 30- and-90 days following hospital discharge by phone interviews in accordance to local standard of care practices, review of in-hospital records or in-clinic visit, as available.
Read the detailed description
The post market surveillance study is designed to capture data in the real-world clinical setting on the use of the Carpediem™ system and will evaluate the safety and performance in children requiring CRRT in the US. Data on survival and the effectiveness of the Carpediem™ system on renal function recovery will be evaluated. A comprehensive evaluation of subjects being treated with Carpediem™ will include, but is not limited to, acuity at hospital/ICU admission and prior to CRRT initiation, Carpediem™ treatment parameters, laboratory data, and requirement for mechanical ventilation and/or inotropic support. Subject status and requirement for renal replacement therapy post hospital discharge will be evaluated at 30- and 90-days.
- Conditions
- Acute Kidney Injury, Fluid Overload
- Being tested
- Carpediem System
- Keywords
- Carpediem(tm), continuous renal replacment therapy, CRRT, acute kidney injury, pediatric, fluid overload, hemodialysis, hemofiltration, post market surveillance, registry
- Medical subject headings
- Acute Kidney Injury, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carpediem SystemDevice
Continuous renal replacement therapy
| Study group | Role | What they receive |
|---|---|---|
| Subjects treated with Carpediem system | All patients who receive CRRT with the Carpediem™ system, as prescribed by the investigator, will be offered participation in the post market surveillance study after obtaining parental consent. Receives: Device: Carpediem System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival at CRRT Discontinuation
Evaluation subject survival at CRRT discontinuation
Measured: from the start of CRRT to the date of death or CRRT discontinuation, assessed up to 100 weeks
Survival at intensive care unit (ICU) discharge
Evaluation subject survival at ICU discharge
Measured: from the start of CRRT to the date of death or ICU dhscharge, assessed up to 100 weeks
Secondary outcomes (6)
Survival through 90 days post hospital discharge
Quantify survival at hospital discharge, and 30- and 90-days post hospital discharge
Measured: hospital discharge through 90 days post discharge
Hospital and ICU length of stay
Evaluation hospital and ICU length of stay
Measured: through discharge, assessed up to 100 weeks
Renal function recovery at discharge and 30- and 90- days post hospital discharge
Assess renal function recovery at hospital discharge and 30- and 90- days post hospital discharge
Measured: Hospital discharge through 90 days post discharge
Overall survival
Characterize overall survival based on variables including, but not limited to; demographic data, laboratory values, patient acuity prior to CRRT initiation and CRRT treatment parameters
Measured: through study completion, an average of 3 years
Time to CRRT discontinuation
Assess time to CRRT discontinuation
Measured: from the start of CRRT to the date of death or CRRT discontinuation, assessed up to 100 weeks
Carpediem system-related adverse events
Quantify the rate of Carpediem system-related adverse events
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start20 Jan 2021
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 36 participants (actual)
- Target duration
- 120 Days
Sponsor and investigators
- Lead sponsor
- Mozarc Medical US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608149
- Sponsor's protocol ID
- MDT20039
- Status last verified
- Sep 2026
- First submitted
- 21 Oct 2020
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carpediem(TM) Post Market Surveillance Study
- ClinicalTrials.gov ID
- NCT04608149
- Acronym / sponsor ID
- MDT20039
- Conditions
- Acute Kidney Injury, Fluid Overload
- Keywords
- Carpediem(tm), continuous renal replacment therapy, CRRT, acute kidney injury, pediatric, fluid overload, hemodialysis, hemofiltration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mozarc Medical US LLCIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 29 Oct 2020 (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.
The post market surveillance study will employ a prospective, multi-center, single-arm, observational design to capture data on children who undergo CRRT using the Carpediem™ system. Participating clinicians will manage subjects in accordance to their local standard of care practices and decisions on initiating, modifying or discontinuing CRRT are up to the local investigative team's prescription.
A minimum of 10 centers in the United States, that have been trained on the use of the Carpediem™ system, will be invited to participate in the study. After obtaining institutional review board approval and written informed consent from a parent or legally authorized representative (LAR), data from all subjects treated with the Carpediem™ system will be included in the study. A minimum of 35 subjects will be enrolled and sites may be asked to screen and enroll patients for the study for up to 36 months.
Status of subjects discharged from hospital will be collected at 30- and-90 days following hospital discharge by phone interviews in accordance to local standard of care practices, review of in-hospital records or in-clinic visit, as available.
Detailed description
The post market surveillance study is designed to capture data in the real-world clinical setting on the use of the Carpediem™ system and will evaluate the safety and performance in children requiring CRRT in the US. Data on survival and the effectiveness of the Carpediem™ system on renal function recovery will be evaluated. A comprehensive evaluation of subjects being treated with Carpediem™ will include, but is not limited to, acuity at hospital/ICU admission and prior to CRRT initiation, Carpediem™ treatment parameters, laboratory data, and requirement for mechanical ventilation and/or inotropic support. Subject status and requirement for renal replacement therapy post hospital discharge will be evaluated at 30- and 90-days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 120 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects treated with Carpediem system | – | Device: Carpediem SystemAll patients who receive CRRT with the Carpediem™ system, as prescribed by the investigator, will be offered participation in the post market surveillance study after obtaining parental consent. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have acute kidney injury or fluid overload requiring hemodialysis or hemofiltration who weigh between 2.5 and 10 kilograms (5.5 to 22 pounds).
Key inclusion criteria (5 listed)
- Parent or LAR has signed information consent
- Subject weighs between 2.5-10 kg (or 5.5-22 lbs)
- Subject is receiving medical care in an intensive care unit
- Parental or LAR consent to receive full supportive care through aggressive management utilizing all available therapies for a minimum of 96 hours
- Subject has a clinical diagnosis of acute kidney injury per Kidney Disease Improving Global Outcomes (KDIGO) criteria or fluid overload requiring CRRT
Key exclusion criteria (9 listed)
- Subject is not expected to survive 72 hours due to an irreversible medical condition, in the opinion of the investigator
- Subject has irreversible brain damage, in the opinion of the investigator
- Subject is intolerant to anticoagulation, as documented in the medical record
- Subject has a Do Not Attempt Resuscitate (DNAR), Allow Natural Death (AND), withdrawal of care or similar order, or anticipated change in status, in the opinion of the investigator, within the next 7 days
- Subject has pre-existing end-stage renal disease or pre-existing, advanced chronic kidney disease, defined as an estimated Glomerular Filtration Rate (eGRF) < 30 ml/min/1.73m2
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 |
|---|---|---|
| Carpediem SystemContinuous renal replacement therapy | Device | Subjects treated with Carpediem system |
Primary outcome
Survival at CRRT Discontinuation
Time frame: from the start of CRRT to the date of death or CRRT discontinuation, assessed up to 100 weeks
Evaluation subject survival at CRRT discontinuation
Survival at intensive care unit (ICU) discharge
Time frame: from the start of CRRT to the date of death or ICU dhscharge, assessed up to 100 weeks
Evaluation subject survival at ICU discharge
6 secondary outcomes
Survival through 90 days post hospital discharge
Time frame: hospital discharge through 90 days post discharge
Hospital and ICU length of stay
Time frame: through discharge, assessed up to 100 weeks
Renal function recovery at discharge and 30- and 90- days post hospital discharge
Time frame: Hospital discharge through 90 days post discharge
Overall survival
Time frame: through study completion, an average of 3 years
Time to CRRT discontinuation
Time frame: from the start of CRRT to the date of death or CRRT discontinuation, assessed up to 100 weeks
Carpediem system-related adverse events
Time frame: through study completion, an average of 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 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 Fluid Overload, run by Mozarc Medical US LLC at 6 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Survival at CRRT Discontinuation (time frame: from the start of CRRT to the date of death or CRRT discontinuation, assessed up to 100 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2026.