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Active, Not Recruiting

NCT Number: NCT04608149

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Acute Kidney Injury Edema Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fluid Overload Kidney Diseases Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Renal Insufficiency Signs and Symptoms Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Iowa Healthcare, Iowa City, Iowa, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Carpediem System

Device

Continuous renal replacement therapy

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Survival through 90 days post hospital discharge

    Time frame: hospital discharge through 90 days post discharge

    Quantify survival at hospital discharge, and 30- and 90-days post hospital discharge

  2. Hospital and ICU length of stay

    Time frame: through discharge, assessed up to 100 weeks

    Evaluation hospital and ICU length of stay

  3. Renal function recovery at discharge and 30- and 90- days post hospital discharge

    Time frame: Hospital discharge through 90 days post discharge

    Assess renal function recovery at hospital discharge and 30- and 90- days post hospital discharge

  4. Overall survival

    Time frame: through study completion, an average of 3 years

    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

  5. Time to CRRT discontinuation

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

    Assess time to CRRT discontinuation

  6. Carpediem system-related adverse events

    Time frame: through study completion, an average of 3 years

    Quantify the rate of Carpediem system-related adverse events

Sponsors and collaborators

Lead sponsor

Mozarc Medical US LLC

Industry

Registry information

Official study title

Carpediem(TM) Post Market Surveillance Study

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Oct 29, 2020
Registry last updated
Apr 1, 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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