Acute Kidney Injury Clinical Trial
— SARCAOfficial 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)
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).
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Fresenius Medical Care North America |
United States,
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. |
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