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Search / Trial NCT02860130

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

Launched by VANTIVE HEALTH LLC · Aug 5, 2016

Trial Information

Current as of July 21, 2025

Terminated

Keywords

Regional Citrate Anticoagulation (Rca) Continuous Renal Replacement Therapy (Crrt) Acute Kidney Injury

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. 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).
  • 2. Adult patients with AKI or other serious conditions who require treatment with CRRT.
  • 3. Patients are expected to remain in the ICU and on CRRT for at least 72 hours after randomization.
  • 4. Patients already receiving standard-of-care CRRT must be randomized within 24 hours of initiation of their standard-of-care CRRT.
  • Exclusion Criteria:
  • 1. 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.
  • 2. 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).
  • 3. Patients who are not candidates for CRRT.
  • 4. Patients who are receiving extracorporeal membrane oxygenation (ECMO) therapy.
  • 5. 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.
  • 6. Patients with fulminant acute liver failure or acute on chronic liver failure as documented by a Child-Pugh Liver Failure Score \> 10.
  • 7. 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.
  • 8. Patients unlikely to survive at least 72 hours.
  • 9. Female patients who are pregnant, lactating, or planning to become pregnant during the study period.
  • 10. Patients who are currently participating in another interventional clinical study.
  • 11. Patients with a medical condition that may interfere with the study objectives.

About Vantive Health Llc

Vantive Health LLC is a forward-thinking clinical trial sponsor dedicated to advancing healthcare through innovative research and development. With a focus on patient-centered approaches, Vantive Health collaborates with healthcare professionals and institutions to design and conduct clinical trials that prioritize safety, efficacy, and ethical standards. The organization leverages cutting-edge technologies and methodologies to streamline trial processes, ensuring timely and accurate data collection. Committed to improving patient outcomes, Vantive Health plays a pivotal role in the translation of scientific discoveries into tangible therapies, ultimately contributing to the enhancement of global health.

Locations

Chicago, Illinois, United States

Kansas City, Kansas, United States

Birmingham, Alabama, United States

Jackson, Mississippi, United States

Atlanta, Georgia, United States

Cleveland, Ohio, United States

Baltimore, Maryland, United States

Tucson, Arizona, United States

New Haven, Connecticut, United States

Birmingham, Alabama, United States

Lexington, Kentucky, United States

Edmonton, Alberta, Canada

Boston, Massachusetts, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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