SAfety of Regional Citrate Anticoagulation (SARCA Study) (SARCA)

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)

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).

Study Overview

• Status: Recruiting
• Conditions: Acute Kidney Injury; ESRD
• Intervention / Treatment: Combination product: Dialysis

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 improved hemodynamic stability compared to intermittent HD. Continuous anticoagulation during CRRT may be needed to prevent premature clotting of the circuit and deliver the prescribed dialysis dose. Unfractionated heparin is the most commonly used anticoagulation during CRRT mainly as a result of familiarity, low cost, and ease of administration. But the main drawback is the risk of bleeding.

An alternative technique to avoid systemic anticoagulation is regional extracorporeal anticoagulation with citrate (RCA). The advantages of RCA are improved circuit patency and fewer bleeding complications. The use of RCA may also reduce the ICU staff workload. Studies have shown longer filter running times which reduced circuit change and set-up time. In addition, anticoagulation related bleeding, and CRRT-related blood transfusions were minimized. Therefore, CRRT with RCA might be more economical than conventional anticoagulation.

The study is to explore the possibility of using the multiFiltrate PRO system with the Ci-Ca module, Cifoban® (Trisodium citrate 4%), Calrecia® (Calcium chloride dihydrate), Ci-Ca dialysate K2 and K4, AV1000 (disposable cassette), and multiBic solution in subjects who are critically ill and receiving CRRT in an acute setting.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Manuela Stauss-Grabo, PhD; Phone Number: +49 1525 469 1929; Email: manuela.stauss-grabo1@freseniusmedicalcare.com
• Study Contact Backup: Name: Anja Derlet-Savoia, PhD; Phone Number: +49 173 965 9356; Email: anja.derlet@freseniusmedicalcare.com

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Recruiting
      • University of Arkansas for Medical Sciences (UAMS)
      • Contact: Alperdis L Keyes
      • Contact: Nithin Karakala
    • Little Rock, Arkansas, United States, 72205
      • Completed
      • John L. McClellan Memorial Veterans' Hospital
  • Florida
    • Orlando, Florida, United States, 32803
      • Not yet recruiting
      • Advent Health Orlando
      • Contact: Arnaldo Lopez Ruiz
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • Recruiting
      • UMass Memorial Medical Center
      • Contact: Ann McCarthy
      • Contact: Matthew Trainor
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-5000
      • Completed
      • University of Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Hospital
      • Contact: Emmy Abraham
      • Contact: Junior Uduman
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Completed
      • Mayo Clinic
  • Mississippi
    • Jackson, Mississippi, United States, 39350
      • Recruiting
      • University of Mississippi Medical Center
      • Contact: Catherine Wells
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Completed
      • Washington University - Hospital
  • Utah
    • Murray, Utah, United States, 84107
      • Recruiting
      • Intermountain Health
      • Contact: Anitha Vijayan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Combination product: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms and systemic ionized calcium level	Defined as a symptomatic episode of delirium, coma, nausea, vomiting, constipation, muscle weakness, hypertension, bradycardia, deemed attributable to hypercalcemia with a confirmed systemic ionized calcium > 1.5mmol/L.	Up to 1 month
Arterial pH measure and bicarbonate level	Arterial pH > 7.55 and bicarbonate > 30 mmol/L in the absence of exogenous bicarbonate administered	Up to 1 month
Serum sodium (Na) level	Serum sodium (Na) level > 150 mmol/L and > 5 mmol/L rise in systemic Na above the prescribed CRRT fluids. Na level in the absence of hypertonic intravenous Na infusion	Up to 1 month
Drop in hemoglobin (Hgb)	Bleeding resulting in more than 2 g/dL drop in hemoglobin (Hgb) in 24-hour period or need for transfusion	Up to 1 month
Symptoms and systemic ionized calcium level	defined as a symptomatic episode of tetany/spasms, seizures, deemed attributable to hypocalcemia and with a confirmed systemic iCa < 0.85 mmol/L.	Up to 1 month
Symptoms and total-to-ionized calcium ratio	Patients with impaired citrate metabolism or citrate overdose can exhibit citrate accumulation. Symptomatic citrate accumulation presents with symptoms of tetany/spasms, seizures, systemic hypocoagulability, hypotension, or cardiac events; and should be confirmed with: A total-to-ionized calcium ratio > 2.5; OR; A total-to-ionized calcium ratio greater than 2.25 together with one or more of the following criteria:an increase in calcium supplementation,decreasing systemic ionized calcium, andmetabolic acidosis. When a clinical presentation is possibly associated with an abnormal concentration of systemic ionized calcium or an altered acid-base balance, the labs ({Calcium: systemic ionized calcium, post-filter ionized calcium and total calcium}, bicarbonate, sodium, potassium, magnesium, phosphate) should be checked immediately.	Up to 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Circuit life	Circuit life is defined by time to circuit replacement	The life of a circuit is 72 hrs and then it needs to be replaced . Subject participation is upto 1 month.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Adverse Events	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Fresenius Medical Care North America
• Investigators: Study Director: Manuela Stauss-Grabo, PhD, Fresenius Medical Care North America

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2023
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: April 8, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: Ci-Ca-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No