Clinical Evaluation of Use of Prismocitrate 18 in Patients Undergoing Acute Continuous Renal Replacement Therapy (CRRT)

Stopped early · Phase 3

Conditions studied: Regional Citrate Anticoagulation (RCA), Continuous Renal Replacement Therapy (CRRT), Acute Kidney Injury

In brief

The purpose of this research is to determine if an investigational new drug solution called Prismocitrate 18 lengthens extracorporeal circuit life in patients treated with continuous renal replacement therapy (CRRT). Patients who receive CRRT treatment with Prismocitrate 18 as the anticoagulant will be compared to patients who receive CRRT treatment with no anticoagulation.

Key facts

Study ID

NCT02860130

Run by

Vantive Health LLC

People needed

34

Starts

2016-09-27

Expected to finish

2018-05-12

Last updated by the study team

2025-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient must be receiving medical care in an intensive care unit (ICU) (e.g., medical ICU, surgical ICU, cardiothoracic ICU, Trauma ICU, Mixed ICU, other).
• Adult patients with AKI or other serious conditions who require treatment with CRRT.
• Patients are expected to remain in the ICU and on CRRT for at least 72 hours after randomization.
• Patients already receiving standard-of-care CRRT must be randomized within 24 hours of initiation of their standard-of-care CRRT.

You may not qualify if…

• Patients requiring systemic anticoagulation with antithrombotic agents for reasons other than CRRT. The exception is patients receiving subcutaneous heparin for deep vein thrombosis prophylaxis according to institutional practice or patients on aspirin may be enrolled.
• Patients in whom citrate anticoagulation is contraindicated such as patients with a known allergy to citrate or who have experienced adverse events associated with citrate products including patients with a prior history of citrate toxicity or patients with uncorrected severe hypocalcemia (whether in the context of current citrate administration or due to the underlying disease state).
• Patients who are not candidates for CRRT.
• Patients who are receiving extracorporeal membrane oxygenation (ECMO) therapy.
• Patients with severe coagulopathy [i.e., platelets < 30,000/mm3, international normalized ratio (INR) > 2, partial thromboplastin time (PTT) > 50 seconds] including severe thrombocytopenia (platelets < 30,000/mm3), HIT (heparin induced thrombocytopenia), ITP (idiopathic thrombocytopenia purpura), and TTP (thrombotic thrombocytopenia purpura) should not be enrolled in the trial.
• Patients with fulminant acute liver failure or acute on chronic liver failure as documented by a Child-Pugh Liver Failure Score > 10.
• Patients with refractory shock associated persistent, worsening with lactic acidosis (lactate > 4 mmol/L). However, patients with improving subsequent serum lactate levels may be enrolled.
• Patients unlikely to survive at least 72 hours.
• Female patients who are pregnant, lactating, or planning to become pregnant during the study period.
• Patients who are currently participating in another interventional clinical study.
• Patients with a medical condition that may interfere with the study objectives.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Arizona — Tucson, Arizona, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Emory University — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• University of Kentucky — Lexington, Kentucky, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Beth Israel Deaconess (Harvard) — Boston, Massachusetts, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Alberta Hospital — Edmonton, Alberta, Canada

Full record on ClinicalTrials.gov

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