Prospective, Multi-center, Single-arm, Observational Study. US FDA 522 Pediatric Post Market Surveillance Study.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Kidney Injury; Fluid Overload
• Intervention / Treatment: Device: Carpediem System

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 Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52252
      • University of Iowa Healthcare
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New York
    • Rochester, New York, United States, 14642
      • Golisano Children's Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital
  • Washington
    • Seattle, Washington, United States, 98103
      • Seattle Children's

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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).

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Carpediem System; Continuous renal replacement therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival at CRRT Discontinuation	Evaluation subject survival at CRRT discontinuation	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	from the start of CRRT to the date of death or ICU dhscharge, assessed up to 100 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival through 90 days post hospital discharge	Quantify survival at hospital discharge, and 30- and 90-days post hospital discharge	hospital discharge through 90 days post discharge
Hospital and ICU length of stay	Evaluation hospital and ICU length of stay	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	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	through study completion, an average of 3 years
Time to CRRT discontinuation	Assess time to CRRT discontinuation	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	through study completion, an average of 3 years

Collaborators and Investigators

• Sponsor: Mozarc Medical US LLC

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2021
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: October 21, 2020
• First Submitted That Met QC Criteria: October 26, 2020
• First Posted (Actual): October 29, 2020

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: pediatric; acute kidney injury; hemodialysis; registry; CRRT; fluid overload; hemofiltration; Carpediem(tm); continuous renal replacment therapy; post market surveillance
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Acute Kidney Injury; Edema
• Other Study ID Numbers: MDT20039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No