Clinical Evaluation of Use of Prismocitrate 18 in Patients Undergoing Acute Continuous Renal Replacement Therapy (CRRT)
NCT ID: NCT02860130
Last Updated: 2025-07-22
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
34 participants
INTERVENTIONAL
2016-09-27
2018-05-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Prismocitrate 18
Prismocitrate 18
Modality of CVVHDF
No Regional Anticoagulation of CRRT Circuit
No Anticoagulation
Modality of CVVHDF
Interventions
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Prismocitrate 18
Modality of CVVHDF
No Anticoagulation
Modality of CVVHDF
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Baxter Healthcare Corporation
INDUSTRY
Vantive Health LLC
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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Tsujimoto H, Tsujimoto Y, Nakata Y, Fujii T, Takahashi S, Akazawa M, Kataoka Y. Pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2020 Dec 14;12(12):CD012467. doi: 10.1002/14651858.CD012467.pub3.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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1407-004
Identifier Type: -
Identifier Source: org_study_id
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