SAfety of Regional Citrate Anticoagulation (SARCA Study)
Part of paid clinical trials in Little Rock, Arkansas.
- Sponsor
- Fresenius Medical Care North America
- Study ID
- NCT05339139
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Acute Kidney Injury
- ESRD
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Dialysis — COMBINATION_PRODUCTIn 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.
Study Details
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).
Key Dates
- Start date
- Oct 17, 2023
- Status verified
- Apr 2025
- Primary completion
- Apr 30, 2025
- Completion
- Jul 31, 2025
Study Design
- Enrollment
- 50 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Ci-Ca ArmThe 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
Primary Outcome Measure
Symptoms and systemic ionized calcium level [ Time Frame: Up to 1 month ]
Central Contacts
- Anja Derlet-Savoia, PhD+49 173 965 9356
- Manuela Stauss-Grabo, PhD+49 1525 469 1929
Locations (10)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| John L. McClellan Memorial Veterans' Hospital | Little Rock | Arkansas | 72205 | - |
| University of Arkansas for Medical Sciences (UAMS) | Little Rock | Arkansas | 72205 | Alperdis L Keyes Nithin Karakala (PRINCIPAL_INVESTIGATOR) |
| Advent Health Orlando | Orlando | Florida | 32803 | Arnaldo Lopez Ruiz (PRINCIPAL_INVESTIGATOR) |
| UMass Memorial Medical Center | Worcester | Massachusetts | 01655 | Ann McCarthy Matthew Trainor (PRINCIPAL_INVESTIGATOR) |
| University of Michigan | Ann Arbor | Michigan | 48109-5000 | - |
| Henry Ford Hospital | Detroit | Michigan | 48202 | Emmy Abraham Junior Uduman (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic | Rochester | Minnesota | 55905 | - |
| University of Mississippi Medical Center | Jackson | Mississippi | 39350 | Catherine Wells Catherine Wells (PRINCIPAL_INVESTIGATOR) |
| Washington University - Hospital | St Louis | Missouri | 63110 | - |
| Intermountain Health | Murray | Utah | 84107 | Anitha Vijayan Anitha Vijayan (PRINCIPAL_INVESTIGATOR) |
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