Status:
RECRUITING
SAfety of Regional Citrate Anticoagulation (SARCA Study)
Lead Sponsor:
Fresenius Medical Care North America
Conditions:
Acute Kidney Injury
ESRD
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 Rep...
Detailed Description
In short, AKI is a major complication in intensive care patients, often occurring in the context of multiple organ failure, and some of these patients may need CRRT. The major advantage of CRRT is imp...
Eligibility Criteria
Inclusion
- Signed informed consent form by
- The subject or
- A legally authorized representative (LAR), if the subject is unable to consent
- Adult patients ≥ 18 years old
- Diagnosis of AKI or End-Stage Kidney Disease (ESKD) requiring CRRT
- Vascular access - Dialysis Catheter with size and location per institutional practice
Exclusion
- Metabolic alkalosis as defined by serum bicarbonate greater than 30 mmol/L and arterial pH greater than 7.55
- A female who is pregnant or breast feeding
- 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
- Subjects currently enrolled in or who have completed any other investigational drug or device study within last 30 days prior to signing informed consent
- Previous participation in a similar or the same study.
- Subjects already on continuous renal replacement therapy
- Subjects with active COVID-19 infection
- Subjects cannot tolerate citrate therapy defined as severe liver disease (see exclusion criteria #3), shock with muscle hypoperfusion and known hypersensitivity to citrate
Key Trial Info
Start Date :
October 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05339139
Start Date
October 17 2023
End Date
July 31 2025
Last Update
April 24 2025
Active Locations (10)
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1
John L. McClellan Memorial Veterans' Hospital
Little Rock, Arkansas, United States, 72205
2
University of Arkansas for Medical Sciences (UAMS)
Little Rock, Arkansas, United States, 72205
3
Advent Health Orlando
Orlando, Florida, United States, 32803
4
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01655