Ensayos clínicos

Inclusion Criteria: 

• Signed informed consent from by
  • The subject; or
  • The LAR, if the subject is unable to consent.
• Adult patients ≥ 18 years old.
• Diagnosis of AKI or ESKD requiring CRRT.
• Vascular access – Dialysis Catheter with size and location per institutional practice.

Exclusion Criteria:

• Metabolic alkalosis as defined by serum bicarbonate greater than 30 mmol/L and arterial pH greater than 7.55.
• A female who is pregnant or breast feeding.
• Severe liver disease defined as INR greater than 2.0 and total bilirubin greater than 5 mg/dL, and both AST and ALT greater than 3 times upper limit of normal.
• Subjects currently enrolled in or who have completed any other investigational drug or device study within last 30 days prior to signing informed consent.
• Previous participation in a similar or the same study.
• Subjects already on continuous renal replacement therapy.
• Subjects with active COVID-19 infection.
• Subject cannot tolerate citrate therapy defined as severe liver disease (see exclusion criteria #3), shock with muscle hypoperfusion and known hypersensitivity to citrate.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 1/22/24. Questions regarding updates should be directed to the study team contact.