Clinical trial NCT04608149: Prospective, Multi-center, Single-arm, Observational Study. US FDA 522 Pediatric Post Market Surveillance Study.
Official title: Carpediem(TM) Post Market Surveillance Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Kidney Injury
Fluid Overload
Keywords: Carpediem(tm)
continuous renal replacment therapy
CRRT
acute kidney injury
pediatric
fluid overload
hemodialysis
hemofiltration
post market surveillance
registry
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2020-10-29
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have acute kidney injury or fluid overload requiring hemodialysis or hemofiltration who weigh between 2.5 and 10 kilograms (5.5 to 22 pounds).

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Survival at CRRT Discontinuation
timeFrame: from the start of CRRT to the date of death or CRRT discontinuation, assessed up to 100 weeks
measure: Survival at intensive care unit (ICU) discharge
timeFrame: from the start of CRRT to the date of death or ICU dhscharge, assessed up to 100 weeks
Secondary outcomes:
measure: Survival through 90 days post hospital discharge
timeFrame: hospital discharge through 90 days post discharge
measure: Hospital and ICU length of stay
timeFrame: through discharge, assessed up to 100 weeks
measure: Renal function recovery at discharge and 30- and 90- days post hospital discharge
timeFrame: Hospital discharge through 90 days post discharge
measure: Overall survival
timeFrame: through study completion, an average of 3 years
measure: Time to CRRT discontinuation
timeFrame: from the start of CRRT to the date of death or CRRT discontinuation, assessed up to 100 weeks
measure: Carpediem system-related adverse events
timeFrame: through study completion, an average of 3 years
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Healthcare
state: Iowa
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Rochester
country: United States
facility: Golisano Children's Hospital
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Seattle
country: United States
facility: Seattle Children's
state: Washington
Study officials:
References: