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

  • STATUS
    Recruiting
  • End date
    Aug 11, 2023
  • participants needed
    35
  • sponsor
    Medtronic - MITG
Updated on 11 February 2021

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.

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.

Details
Condition Renal Failure, Acute renal failure, Fluid Overload, Volume Overload, Kidney Failure (Pediatric), Kidney Failure, hypervolemia, hyperhydration, acute kidney injury, acute kidney injuries
Treatment Carpediem System
Clinical Study IdentifierNCT04608149
SponsorMedtronic - MITG
Last Modified on11 February 2021

Eligibility

Yes No Not Sure

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 has received at least 12 hours of CRRT with another machine (not including ECMO) during the current hospitalization
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
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