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

Acute Kidney Injury Clinical Trial

Official title:

Carpediem(TM) Post Market Surveillance Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04608149
• Other study ID #: MDT20039
• Status: Recruiting
• Start date: January 20, 2021
• Est. completion date: August 2024

Study information

• Verified date: October 2023
• Source: Medtronic - MITG
• Contact: Amy Roettger
• Phone: 763-505-4566
• Email: amy.denise.roettger[@]medtronic.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: August 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Fluid Overload

Intervention

Device:
• Carpediem System
Continuous renal replacement therapy

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Texas Children's Hospital	Houston	Texas
United States	University of Iowa Healthcare	Iowa City	Iowa
United States	Golisano Children's Hospital	Rochester	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	Seattle Children's	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Hospital and ICU length of stay	Evaluation hospital and ICU length of stay	through discharge, assessed up to 100 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Carpediem system-related adverse events	Quantify the rate of Carpediem system-related adverse events	through study completion, an average of 3 years