Assessing the safety of citrate anticoagulation in kidney patients on dialysis
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)
This study is testing if using citrate instead of heparin as a blood thinner during dialysis can help keep the equipment working better and reduce bleeding problems for patients with severe kidney issues.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fresenius Medical Care North America Industry-sponsored |
| Locations | 10 sites (Little Rock, Arkansas and 9 other locations) |
| Trial ID | NCT05339139 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety of using regional citrate anticoagulation during continuous renal replacement therapy (CRRT) in adult patients with acute kidney injury or end-stage kidney disease. It is an open-label, prospective, multicenter trial that utilizes the multiFiltratePRO system to deliver citrate anticoagulation, aiming to improve circuit patency and reduce bleeding complications compared to traditional heparin anticoagulation. The study will involve critically ill patients requiring CRRT, and it seeks to determine the effectiveness and safety of this alternative anticoagulation method.
Who should consider this trial
Good fit: Ideal candidates include adult patients aged 18 and older diagnosed with acute kidney injury or end-stage kidney disease requiring continuous renal replacement therapy.
Not a fit: Patients with metabolic alkalosis, severe liver disease, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer dialysis treatments with fewer bleeding complications for critically ill patients.
How similar studies have performed: Previous studies have indicated that regional citrate anticoagulation may improve outcomes in similar patient populations, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Signed informed consent form by * The subject or * A legally authorized representative (LAR), if the subject is unable to consent 2. Adult patients ≥ 18 years old 3. Diagnosis of AKI or End-Stage Kidney Disease (ESKD) requiring CRRT 4. Vascular access - Dialysis Catheter with size and location per institutional practice Exclusion Criteria: 1. Metabolic alkalosis as defined by serum bicarbonate greater than 30 mmol/L and arterial pH greater than 7.55 2. A female who is pregnant or breast feeding 3. 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 4. Subjects currently enrolled in or who have completed any other investigational drug or device study within last 30 days prior to signing informed consent 5. Previous participation in a similar or the same study. 6. Subjects already on continuous renal replacement therapy 7. Subjects with active COVID-19 infection 8. Subjects cannot tolerate citrate therapy defined as severe liver disease (see exclusion criteria #3), shock with muscle hypoperfusion and known hypersensitivity to citrate
Where this trial is running
Little Rock, Arkansas and 9 other locations
- John L. McClellan Memorial Veterans' Hospital — Little Rock, Arkansas, United States (Completed)
- University of Arkansas for Medical Sciences (UAMS) — Little Rock, Arkansas, United States (Recruiting)
- Advent Health Orlando — Orlando, Florida, United States (Not_yet_recruiting)
- UMass Memorial Medical Center — Worcester, Massachusetts, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Completed)
- Henry Ford Hospital — Detroit, Michigan, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Completed)
- University of Mississippi Medical Center — Jackson, Mississippi, United States (Recruiting)
- Washington University - Hospital — St Louis, Missouri, United States (Completed)
- Intermountain Health — Murray, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Anja Derlet-Savoia, PhD
- Email: anja.derlet@freseniusmedicalcare.com
- Phone: +49 173 965 9356
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.