Clinical Trials

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.