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

Sponsor

Medtronic - MITG (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04608149

Collaborator

(none)

Enrollment

Locations

30.3

Anticipated Duration (Months)

5.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury Fluid Overload	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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

35 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Carpediem(TM) Post Market Surveillance Study

Actual Study Start Date :

Jan 20, 2021

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Survival at CRRT Discontinuation [from the start of CRRT to the date of death or CRRT discontinuation, assessed up to 100 weeks]
Evaluation subject survival at CRRT discontinuation
Survival at intensive care unit (ICU) discharge [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 Outcome Measures

Survival through 90 days post hospital discharge [hospital discharge through 90 days post discharge]
Quantify survival at hospital discharge, and 30- and 90-days post hospital discharge
Hospital and ICU length of stay [through discharge, assessed up to 100 weeks]
Evaluation hospital and ICU length of stay
Renal function recovery at discharge and 30- and 90- days post hospital discharge [Hospital discharge through 90 days post discharge]
Assess renal function recovery at hospital discharge and 30- and 90- days post hospital discharge
Overall survival [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
Time to CRRT discontinuation [from the start of CRRT to the date of death or CRRT discontinuation, assessed up to 100 weeks]
Assess time to CRRT discontinuation
Carpediem system-related adverse events [through study completion, an average of 3 years]
Quantify the rate of Carpediem system-related adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Iowa Healthcare	Iowa City	Iowa	United States	52252
2	CS Mott Children's Hospital	Ann Arbor	Michigan	United States	48109
3	Mayo Clinic	Rochester	Minnesota	United States	55905
4	Golisano Children's Hospital	Rochester	New York	United States	14642
5	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229
6	Seattle Children's	Seattle	Washington	United States	98103