SAfety of Regional Citrate Anticoagulation (SARCA Study)

Description

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

Acute Kidney Injury, ESRD

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Study Overview

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Study Details

Study overview

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).

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)

SAfety of Regional Citrate Anticoagulation (SARCA Study)

Condition
Acute Kidney Injury
Intervention / Treatment

-

Contacts and Locations

Little Rock

John L. McClellan Memorial Veterans' Hospital, Little Rock, Arkansas, United States, 72205

Little Rock

University of Arkansas for Medical Sciences (UAMS), Little Rock, Arkansas, United States, 72205

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109-5000

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Saint Louis

Washington University - Hospital, Saint Louis, Missouri, United States, 63110

Murray

Intermountain Health, Murray, Utah, United States, 84107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Signed informed consent form by
  • * 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
  • 1. Metabolic alkalosis as defined by serum bicarbonate greater than 30 mmol/L and arterial pH greater than 7.55
  • 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
  • 8. Subjects cannot tolerate citrate therapy defined as severe liver disease (see exclusion criteria #3), shock with muscle hypoperfusion and known hypersensitivity to citrate

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Fresenius Medical Care North America,

Manuela Stauss-Grabo, PhD, STUDY_DIRECTOR, Fresenius Medical Care North America

Study Record Dates

2025-03-30