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_PRODUCT
    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.

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 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

Primary Outcome Measure

Symptoms and systemic ionized calcium level [ Time Frame: Up to 1 month ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
John L. McClellan Memorial Veterans' HospitalLittle RockArkansas72205-
University of Arkansas for Medical Sciences (UAMS)Little RockArkansas72205
Alperdis L Keyes
Nithin Karakala (PRINCIPAL_INVESTIGATOR)
Advent Health OrlandoOrlandoFlorida32803
Arnaldo Lopez Ruiz (PRINCIPAL_INVESTIGATOR)
UMass Memorial Medical CenterWorcesterMassachusetts01655
Ann McCarthy
Matthew Trainor (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109-5000-
Henry Ford HospitalDetroitMichigan48202
Emmy Abraham
Junior Uduman (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905-
University of Mississippi Medical CenterJacksonMississippi39350
Catherine Wells
Catherine Wells (PRINCIPAL_INVESTIGATOR)
Washington University - HospitalSt LouisMissouri63110-
Intermountain HealthMurrayUtah84107
Anitha Vijayan
Anitha Vijayan (PRINCIPAL_INVESTIGATOR)

Find similar trials in Little Rock, AR

Related Studies