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

NCT04608149 | Active Not Recruiting FDA Device

• 1 other identifier: MDT20039
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 6

Brief 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. 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.

Conditions

Fluid Overload; Acute Kidney Injury

Keywords

Carpediem(tm); continuous renal replacment therapy; CRRT; acute kidney injury; pediatric; fluid overload; hemodialysis; hemofiltration; post market surveillance; registry

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Survival through 90 days post hospital discharge

  hospital discharge through 90 days post discharge

• 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

  Hospital discharge through 90 days post discharge

• Overall survival

  through study completion, an average of 3 years

• Time to CRRT discontinuation

  from the start of CRRT to the date of death or CRRT discontinuation, assessed up to 100 weeks

Study Arms (1)

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

Interventions

Carpediem System DEVICE

Continuous renal replacement therapy

Subjects treated with Carpediem system

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mozarc Medical US LLC: lead

Study Sites (6)

University of Iowa Healthcare

Iowa City, Iowa, 52252, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Golisano Children's Hospital

Rochester, New York, 14642, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Seattle Children's

Seattle, Washington, 98103, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury; Edema

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 120 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Post-Marketing Study: Yes

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 29, 2020
• Study Start: January 20, 2021
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)