| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05339139 | SAfety of Regional Citrate Anticoagulation (SARCA Study) | PHASE3 | RECRUITING | 50 | — | — | Oct 17, 2023 | Jul 31, 2025 | Apr 24, 2025 | 10 | United States |
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.
Arterial pH \> 7.55 and bicarbonate \> 30 mmol/L in the absence of exogenous bicarbonate administered
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
Bleeding resulting in more than 2 g/dL drop in hemoglobin (Hgb) in 24-hour period or need for transfusion
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: 1. A total-to-ionized calcium ratio \> 2.5; OR 2. A total-to-ionized calcium ratio greater than 2.25 together with one or more of the following criteria: 1. an increase in calcium supplementation, 2. decreasing systemic ionized calcium, and 3. 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.
| Arm | Type | Description |
|---|---|---|
| Ci-Ca Arm | EXPERIMENTAL | 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 |
| Name | Type | Description |
|---|---|---|
| Dialysis | COMBINATION_PRODUCT | 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. |
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 Cathet...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Fresenius Medical Care AG Sponsored ADR | FMS | 2 | PHASE3 | Dialysis |
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
| CalciMedica, Inc. | CALC | 1 | PHASE2 | Auxora |
| Talphera, Inc. | TLPH | 1 | NA | Undisclosed |
| SeaStar Medical Holding Corporation | ICU | 2 | — | Undisclosed |
| Collegium Pharmaceutical, Inc. | COLL | 1 | — | Flozin |