Acute Kidney Injury (AKI), Continuous Renal Replacement Therapy (CRRT), Regional Citrate Anticoagulation (RCA)
Conditions
Brief summary
Prismocitrate 18 is a continuous renal replacement therapy (CRRT) solution to be used as a renal replacement solution and as an anticoagulant to prevent blood clotting in the extracorporeal circuit. The delivery of CRRT therapy is provided by the PrisMax System which includes regional citrate anticoagulation (RCA) software to facilitate citrate and calcium compensation prescription. The objectives of this study are: 1) to confirm the safety of Prismocitrate 18 in patients receiving CRRT using continuous venovenous hemodiafiltration (CVVHDF) or continuous venovenous hemofiltration (CVVH) and 2) to observe that the software and interface for the PrisMax System Version 3.x with calcium line accessory allows for implementation of regional citrate anticoagulation (RCA) (citrate and calcium dosing) during CRRT with Prismocitrate 18 and intended prescription. The study period of the patient's CRRT will be up to 10 days.
Interventions
DRUGPrismocitrate 18
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.
DEVICEPrisMax System Version 3.x with calcium line accessory
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.
Sponsors
Vantive Health LLC
Baxter Healthcare Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 written informed consent form (ICF) per 21 CFR Part 50.55(e)
Exclusion criteria
* Patients with a known allergy to citrate or who have ever experienced an adverse reaction associated with citrate products, including patients with a prior history of citrate toxicity * Patients with acute liver failure, defined by the occurrence of encephalopathy and hepatic synthetic dysfunction within 26 weeks of the first symptoms of liver disease and without evidence of chronic liver disease * Patients with acute-on-chronic liver failure characterized by acute decompensation of cirrhosis and a Child-Pugh Liver Failure Score \>10 * Patients with refractory shock and associated lactic acidosis (lactate \>4 mmol/L) * Patients with a systemic ionized calcium concentration outside the normal physiologic range (1.0 - 1.3 mmol/L), or outside of the laboratory reference range (Note: It is acceptable to provide calcium supplementation or treatment for hypercalcemia to achieve a normal physiologic range prior to therapy initiation) * Female patients of childbearing potential who are pregnant or breastfeeding. (Note: All female patients, who have not undergone a hysterectomy, bilateral oophorectomy with or without hysterectomy, or has medically documented ovarian failure before study Screening must have a negative serum beta human chorionic gonadotropic \[B-hCG\] pregnancy test at Screening) * Patients who are currently participating in another interventional clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with symptomatic hypocalcemia related to Prismocitrate 18 administration | Day 1 up to Day 10 | 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. |
| Number of participants with symptomatic hypercalcemia related to Prismocitrate 18 administration | Day 1 up to Day 10 | 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. |
| Number of participants with symptomatic citrate accumulation related to Prismocitrate 18 administration | Day 1 up to Day 10 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Adverse Events related to study product and/or procedure | Day 1 up to Day 28 | Incidence of AE and SAE's are also considered secondary outcome measures and will be reported in the Adverse Event section |
| Delivery of regional citrate anticoagulation (RCA) therapy using PrisMax System Version 3.x | Day 1 up to Day 10 | Percentage of complete RCA treatments according to protocol |
Countries
United States
Contacts
CONTACTGlobal CORP Clinical Trials Disclosure
Outcome results
None listed