Actively Recruiting
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)
Led by Fresenius Medical Care North America · Updated on 2025-04-24
50
Participants Needed
10
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to assess the safety of regional citrate anticoagulation (RCA) delivered by the multiFiltratePRO system in adult patients who need continuous renal replacement therapy (CRRT). The study focuses on patients with acute kidney injury (AKI) or end-stage kidney disease (ESKD), conditions common in intensive care settings and often requiring CRRT due to complications like multiple organ failure. The study explores RCA as an alternative to traditional anticoagulation, aiming to reduce bleeding risks and improve circuit patency during CRRT. Participants will receive RCA through the multiFiltratePRO system, which includes the Ci-Ca module, trisodium citrate 4% (Cifoban®), calcium chloride dihydrate (Calrecia®), specialized dialysates, and disposable cassettes. This open-label, multicenter study involves delivering RCA continuously to critically ill adults requiring CRRT, with treatments managed according to institutional protocols and device specifications. During the study, participants will be monitored for symptoms and blood levels of ionized calcium, arterial pH, bicarbonate, serum sodium, hemoglobin changes, and calcium ratios for up to one month. Circuit life will also be observed, with each circuit lasting up to 72 hours before replacement. The study involves regular clinical assessments, laboratory tests, and safety monitoring to evaluate the anticoagulation method's effects and potential risks over the treatment period.
CONDITIONS
Brief Title
SAfety of Regional Citrate Anticoagulation (SARCA Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form by the subject or a legally authorized representative if unable to consent
- Adult patients 18 years old or older
- Diagnosis of acute kidney injury or end-stage kidney disease requiring continuous renal replacement therapy
- Vascular access via dialysis catheter with size and location 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 who is pregnant or breastfeeding
- Severe liver disease defined by INR greater than 2.0, total bilirubin greater than 5 mg/dl, and both AST and ALT greater than 3 times the upper limit of normal
- Currently enrolled in or completed any other investigational drug or device study within 30 days prior to consent
- Previous participation in a similar or the same study
- Already on continuous renal replacement therapy
- Active COVID-19 infection
- Cannot tolerate citrate therapy due to severe liver disease, shock with muscle hypoperfusion, or known hypersensitivity to citrate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 month
Participants receive Continuous Renal Replacement Therapy (CRRT) with Regional Citrate Anticoagulation (RCA) delivered by the multiFiltratePRO system in an acute setting.
Visits as required for therapy and circuit replacement approximately every 72 hours
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
M
Manuela Stauss-Grabo, PhD
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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