SAfety of Regional Citrate Anticoagulation (SARCA Study)
Recruiting · NCT05339139 · Interventional (participants receive a specific treatment) · Lead sponsor: Fresenius Medical Care North America
View the official record on ClinicalTrials.gov →Interventions studied
Dialysis
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
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 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
10 locations listed across 8 US states.
- John L. McClellan Memorial Veterans' Hospital - Little Rock, Arkansas, United States
- University of Arkansas for Medical Sciences (UAMS) - Little Rock, Arkansas, United States
- Advent Health Orlando - Orlando, Florida, United States
- UMass Memorial Medical Center - Worcester, Massachusetts, United States
- University of Michigan - Ann Arbor, Michigan, United States
- Henry Ford Hospital - Detroit, Michigan, United States
- Mayo Clinic - Rochester, Minnesota, United States
- University of Mississippi Medical Center - Jackson, Mississippi, United States
- Washington University - Hospital - St Louis, Missouri, United States
- Intermountain Health - Murray, Utah, United States