SAfety of Regional Citrate Anticoagulation (SARCA Study)

Recruiting now · Phase 3

Conditions studied: Acute Kidney Injury, ESRD

In brief

This is an Open-label, Prospective, Multicenter Study to Assess the SAfety of Regional Citrate Anticoagulation Delivered by the multiFiltratePRO system in Adult Patients Requiring Continuous Renal Replacement Therapy (SARCA Study).

Key facts

Study ID

NCT05339139

Run by

Fresenius Medical Care North America

People needed

50

Starts

2023-10-17

Expected to finish

2025-07-31

Last updated by the study team

2025-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent form by
• The subject or
• A legally authorized representative (LAR), if the subject is unable to consent
• Adult patients ≥ 18 years old
• Diagnosis of AKI or End-Stage Kidney Disease (ESKD) requiring CRRT
• Vascular access - Dialysis Catheter with size and location per institutional practice

You may not qualify if…

• 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 International Normalized Ratio (INR) greater than 2.0 and total bilirubin greater than 5 mg/dl, and both aspartate aminotransferase (AST) and alanine aminotransferase (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
• Subjects cannot tolerate citrate therapy defined as severe liver disease (see exclusion criteria #3), shock with muscle hypoperfusion and known hypersensitivity to citrate

Where it is running

• Intermountain Health — Murray, Utah, United States (enrolling)
• University of Arkansas for Medical Sciences (UAMS) — Little Rock, Arkansas, United States (enrolling)
• UMass Memorial Medical Center — Worcester, Massachusetts, United States (enrolling)
• Henry Ford Hospital — Detroit, Michigan, United States (enrolling)
• University of Mississippi Medical Center — Jackson, Mississippi, United States (enrolling)
• Washington University - Hospital — St Louis, Missouri, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Advent Health Orlando — Orlando, Florida, United States
• John L. McClellan Memorial Veterans' Hospital — Little Rock, Arkansas, United States
• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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