SAfety of Regional Citrate Anticoagulation (SARCA Study)
NCT ID: NCT05339139
Last Updated: 2025-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
50 participants
INTERVENTIONAL
2023-10-17
2025-07-31
Brief Summary
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Detailed Description
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An alternative technique to avoid systemic anticoagulation is regional extracorporeal anticoagulation with citrate (RCA). The advantages of RCA are improved circuit patency and fewer bleeding complications. The use of RCA may also reduce the ICU staff workload. Studies have shown longer filter running times which reduced circuit change and set-up time. In addition, anticoagulation related bleeding, and CRRT-related blood transfusions were minimized. Therefore, CRRT with RCA might be more economical than conventional anticoagulation.
The study is to explore the possibility of using the multiFiltrate PRO system with the Ci-Ca module, Cifoban® (Trisodium citrate 4%), Calrecia® (Calcium chloride dihydrate), Ci-Ca dialysate K2 and K4, AV1000 (disposable cassette), and multiBic solution in subjects who are critically ill and receiving CRRT in an acute setting.
Conditions
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Study Design
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NA
SINGLE_GROUP
RCA treatment should be used until the end of CRRT. The circuit needs to be replaced after 72 hours of running time.
TREATMENT
NONE
Study Groups
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Ci-Ca Arm
The study population will include critically ill subjects who are a minimum of 18 years old, in an acute setting, requiring CRRT. the Subjects will receive Regional Citrate Anticoagulation (RCA) which will be delivered by MultiFiltiratePRO system
Dialysis
In this study critically ill adult patients requiring Continuous Renal Replacement Therapy (CRRT) will receive Regional Citrate Anticoagulation (CRA) which will be delivered by multiFiltratePRO system.
Interventions
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Dialysis
In this study critically ill adult patients requiring Continuous Renal Replacement Therapy (CRRT) will receive Regional Citrate Anticoagulation (CRA) which will be delivered by multiFiltratePRO system.
Eligibility Criteria
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Inclusion Criteria
* 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
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
18 Years
ALL
No
Sponsors
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Fresenius Medical Care North America
INDUSTRY
Responsible Party
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Principal Investigators
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Manuela Stauss-Grabo, PhD
Role: STUDY_DIRECTOR
Fresenius Medical Care North America
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Alperdis L Keyes
Role: primary
Ann McCarthy
Role: primary
Emmy Abraham
Role: primary
Catherine Wells
Role: primary
Anitha Vijayan
Role: primary
Other Identifiers
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Ci-Ca-001
Identifier Type: -
Identifier Source: org_study_id
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