Clinical trial NCT05339139: SAfety of Regional Citrate Anticoagulation (SARCA Study)
Official title: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Acute Kidney Injury
ESRD
Lead sponsor: Fresenius Medical Care North America
Sponsor class: INDUSTRY
First posted: 2022-04-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an open label, prospective, single-arm, multicenter study with adult patients requiring CRRT. In this study, the subjects will receive CRRT on the mFTPRO system with RCA.

RCA treatment should be used until the end of CRRT. The circuit needs to be replaced after 72 hours of running time.
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Symptoms and systemic ionized calcium level
timeFrame: Up to 1 month
measure: Arterial pH measure and bicarbonate level
timeFrame: Up to 1 month
measure: Serum sodium (Na) level
timeFrame: Up to 1 month
measure: Drop in hemoglobin (Hgb)
timeFrame: Up to 1 month
measure: Symptoms and systemic ionized calcium level
timeFrame: Up to 1 month
measure: Symptoms and total-to-ionized calcium ratio
timeFrame: Up to 1 month
Secondary outcomes:
measure: Circuit life
timeFrame: The life of a circuit is 72 hrs and then it needs to be replaced . Subject participation is upto 1 month.
Other outcomes:
measure: Adverse Events
timeFrame: through study completion, an average of 1 year
Locations:
city: Little Rock
country: United States
facility: John L. McClellan Memorial Veterans' Hospital
state: Arkansas
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences (UAMS)
state: Arkansas
city: Orlando
country: United States
facility: Advent Health Orlando
state: Florida
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Saint Louis
country: United States
facility: Washington University - Hospital
state: Missouri
city: Murray
country: United States
facility: Intermountain Health
state: Utah
Study officials:
affiliation: Fresenius Medical Care North America
name: Manuela Stauss-Grabo, PhD
role: STUDY_DIRECTOR
References: