Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT05339139

SAfety of Regional Citrate Anticoagulation (SARCA Study)

Led by Fresenius Medical Care North America · Updated on 2025-04-24

50

Participants Needed

10

Research Sites

93 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

SAfety of Regional Citrate Anticoagulation (SARCA Study)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent by the patient or legally authorized representative
  • Adult patients 18 years or older
  • Diagnosis of acute kidney injury (AKI) or end-stage kidney disease (ESKD) requiring continuous renal replacement therapy (CRRT)
  • Presence of a dialysis catheter for vascular access as per institutional practice
Not Eligible

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 patients who are pregnant or breastfeeding
  • Severe liver disease with INR greater than 2.0, total bilirubin over 5 mg/dl, and AST and ALT more than three times the upper normal limit
  • Participation in another investigational drug or device study within 30 days before consent
  • Previous participation in this or a similar study
  • Already receiving continuous renal replacement therapy
  • Active COVID-19 infection
  • Inability to tolerate citrate therapy due to severe liver disease, shock with muscle hypoperfusion, or known citrate hypersensitivity

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

Research Team

A

Anja Derlet-Savoia, PhD

CONTACT

M

Manuela Stauss-Grabo, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here