Recruiting
Phase 3

Regional Citrate Anticoagulation

Sponsor:

Fresenius Medical Care North America

Code:

NCT05339139

Conditions

Acute Kidney Injury

ESRD

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dialysis

Study Details

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 Replacement Therapy (SARCA Study).

Conditions

Acute Kidney Injury

ESRD

Study ID

NCT05339139

Start date

Oct 17, 2023

Status verified date

Apr, 2025

Completion date

Jul 31, 2025

Anticipated

Primary completion date

Apr 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion 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

Exclusion Criteria:

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Dialysis

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.

Primary outcome measure

  • Symptoms and systemic ionized calcium level [ Time Frame: Up to 1 month ]
  • Arterial pH measure and bicarbonate level [ Time Frame: Up to 1 month ]
  • Serum sodium (Na) level [ Time Frame: Up to 1 month ]
  • Drop in hemoglobin (Hgb) [ Time Frame: Up to 1 month ]
  • Symptoms and systemic ionized calcium level [ Time Frame: Up to 1 month ]
  • Symptoms and total-to-ionized calcium ratio [ Time Frame: Up to 1 month ]

Central Contacts and Locations

Locations

University of Arkansas for Medical Sciences (UAMS)

Recruiting

Little Rock, Arkansas, United States, 72205

Principal Investigator:

Nithin Karakala

UMass Memorial Medical Center

Recruiting

Worcester, Massachusetts, United States, 01655

Principal Investigator:

Matthew Trainor

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Principal Investigator:

Junior Uduman

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39350

Principal Investigator:

Catherine Wells

Intermountain Health

Recruiting

Murray, Utah, United States, 84107

Principal Investigator:

Anitha Vijayan

More Information

Sponsor

Fresenius Medical Care North America

Last update posted

Apr 24, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Fresenius Medical Care North America on 2025-04-24.