Actively Recruiting
SAfety of Regional Citrate Anticoagulation (SARCA Study)
Led by Fresenius Medical Care North America · Updated on 2025-04-24
50
Participants Needed
10
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
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).
CONDITIONS
Official Title
SAfety of Regional Citrate Anticoagulation (SARCA Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent by the patient or legally authorized representative
- Adult patients 18 years or older
- Diagnosis of acute kidney injury (AKI) or end-stage kidney disease (ESKD) requiring continuous renal replacement therapy (CRRT)
- Presence of a dialysis catheter for vascular access as per institutional practice
You will not qualify if you...
- Metabolic alkalosis defined by serum bicarbonate greater than 30 mmol/L and arterial pH greater than 7.55
- Female patients who are pregnant or breastfeeding
- Severe liver disease with INR greater than 2.0, total bilirubin over 5 mg/dl, and AST and ALT more than three times the upper normal limit
- Participation in another investigational drug or device study within 30 days before consent
- Previous participation in this or a similar study
- Already receiving continuous renal replacement therapy
- Active COVID-19 infection
- Inability to tolerate citrate therapy due to severe liver disease, shock with muscle hypoperfusion, or known citrate hypersensitivity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
John L. McClellan Memorial Veterans' Hospital
Little Rock, Arkansas, United States, 72205
Completed
2
University of Arkansas for Medical Sciences (UAMS)
Little Rock, Arkansas, United States, 72205
Actively Recruiting
3
Advent Health Orlando
Orlando, Florida, United States, 32803
Not Yet Recruiting
4
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01655
Actively Recruiting
5
University of Michigan
Ann Arbor, Michigan, United States, 48109-5000
Completed
6
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
7
Mayo Clinic
Rochester, Minnesota, United States, 55905
Completed
8
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39350
Actively Recruiting
9
Washington University - Hospital
St Louis, Missouri, United States, 63110
Completed
10
Intermountain Health
Murray, Utah, United States, 84107
Actively Recruiting
Research Team
A
Anja Derlet-Savoia, PhD
CONTACT
M
Manuela Stauss-Grabo, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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