Prospective, Multi-center, Single-arm, Observational Study. US FDA 522 Pediatric Post Market Surveillance Study.
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 21-012849
NCT ID: NCT04608149
About this study
The purpose of this post-market surveillance study is 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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 3/22/2024. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Cheryl Tran, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available