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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Carpediem(TM) Post Market Surveillance Study

Conditions
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Acute Kidney Injury, Fluid Overload

Intervention / Treatment
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* Device: Carpediem System


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects treated with Carpediem system<br>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<br>* Continuous renal replacement therapy<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carpediem(tm), continuous renal replacment therapy, CRRT, acute kidney injury, pediatric, fluid overload, hemodialysis, hemofiltration, post market surveillance, registry