SAfety of Regional Citrate Anticoagulation (SARCA Study)

Acute Kidney Injury Clinical Trial

— SARCA  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05339139
• Other study ID #: Ci-Ca-001
• Status: Recruiting
• Phase: Phase 3
• Start date: October 17, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: Fresenius Medical Care North America
• Contact: Neha Ghosh, PhD
• Phone: +1 734-957-6920
• Email: neha.ghosh[@]freseniusmedicalcare.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• ESRD

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Arkansas for Medical Sciences (UAMS)	Little Rock	Arkansas
United States	Mayo Clinic	Rochester	Minnesota
United States	Washington University - Hospital	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Medical Care North America

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events	Adverse Events	through study completion, an average of 1 year
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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, and; metabolic 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	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.