Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05399537 | Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT | PHASE3 | RECRUITING | 40 | — | — | Jul 12, 2024 | Dec 1, 2026 | Apr 13, 2026 | 14 | United States |
Defined as symptomatic patients (e.g., tetany/spasms, seizures, or cardiac events secondary to a prolonged QT interval), with symptoms deemed attributable to hypocalcemia and with a confirmed systemic ionized calcium \< 0.9 mmol/L.
Defined as symptomatic patients (e.g., changes in mental status not explained by the interventions or underlying conditions or cardiac events secondary to a shortened QT interval), with symptoms deemed attributable to hypercalcemia and with a confirmed systemic ionized calcium \> 1.4 mmol/L.
Defined as symptomatic patients (e.g., refractory acidosis), with symptoms deemed attributable to citrate accumulation and with a systemic total calcium to ionized calcium ratio \> 2.5.
| Arm | Type | Description |
|---|---|---|
| Prismocitrate 18 using the PrisMax System Version 3.x with calcium line accessory | EXPERIMENTAL | This is a single-arm study. Patients will receive regional citrate anticoagulation (RCA) with Prismocitrate 18 (investigational drug) during their CRRT treatment using the PrisMax System Version 3.x with calcium line accessory (investigational device). |
| Name | Type | Description |
|---|---|---|
| Prismocitrate 18 | DRUG | Prismocitrate 18 solution (investigational drug) will be used in pre-dilution mode only; the rate of administration depends on the targeted citrate dose and the prescribed flow rate. The pre-filter infusion rate of Prismocitrate 18 solution will be indexed to the blood flow rate (BFR) to achieve a target blood citrate concentration of 3 mmol/L of blood. The flow rate for the anticoagulation of the extracorporeal circuit will be titrated to achieve a post-filter concentration of iCa of 0.25 to 0.35 mmol/L. |
| PrisMax System Version 3.x with calcium line accessory | DEVICE | The RCA software on PrisMax System Version 3.x with calcium line accessory (investigational device) will be enabled to carefully guide the health practitioner for citrate dosing and calcium compensation. |
Inclusion Criteria: * Patients must be ≥18 years of age * Patients who are candidates for CRRT * Patients expected to survive for at least 24 hours * Patients with a contraindication to heparin or an increased risk of hemorrhage * Patient and/or legally-authorized representative has signed a writte...