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

This study is currently recruiting participants.
Verified October 2017 by Baxter Healthcare Corporation
Sponsor:
ClinicalTrials.gov Identifier:
NCT02860130
First Posted: August 9, 2016
Last Update Posted: October 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Baxter Healthcare Corporation
  Purpose
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.

Condition Intervention Phase
Regional Citrate Anticoagulation (RCA) Continuous Renal Replacement Therapy (CRRT) Acute Kidney Injury Drug: Prismocitrate 18 Other: No Anticoagulation Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Use of Prismocitrate 18 in Patients Undergoing Acute Continuous Renal Replacement Therapy (CRRT)

Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Time to occurrence of selected Prismaflex® System alarms/conditions [ Time Frame: Up to 120 hours post CRRT treatment initiation ]

Secondary Outcome Measures:
  • Systemic blood iCa concentrations [ Time Frame: Baseline and up to 120 hours post CRRT treatment initiation ]
  • Post-filter blood iCa concentrations [ Time Frame: Up to 120 hours post CRRT treatment initiation ]
    Post-filter blood iCa concentrations will only be measured in the Prismocitrate 18 arm

  • Delivery of prescribed CRRT dose [ Time Frame: Up to 120 hours post CRRT treatment initiation ]
  • Prismocitrate 18 training assessment [ Time Frame: Prior to study use of Prismocitrate 18 ]
    Training to be completed on administration of Prismocitrate 18. Users, as delegated by the Principal Investigator, will be required to pass an assessment to demonstrate the understanding of how to use the solution.

  • Serum Bicarbonate [ Time Frame: Baseline and up to 120 hours post CRRT treatment initiation ]
  • pH [ Time Frame: Baseline and up to 120 hours post CRRT treatment initiation ]
  • Base Excess [ Time Frame: Baseline and up to 120 hours post CRRT treatment initiation ]
  • Blood Total Calcium Concentration [ Time Frame: Baseline and up to 120 hours post CRRT treatment initiation ]
  • Serum Sodium [ Time Frame: Baseline and up to 120 hours post CRRT treatment initiation ]
  • Serum Anion Gap [ Time Frame: Baseline and up to 120 hours post CRRT treatment initiation ]
  • Serum Magnesium [ Time Frame: Baseline and up to 120 hours post CRRT treatment initiation ]
  • Serum Phosphate [ Time Frame: Baseline and up to 120 hours post CRRT treatment initiation ]
  • Serum Potassium [ Time Frame: Baseline and up to 120 hours post CRRT treatment initiation ]
  • Serum Chloride [ Time Frame: Baseline and up to 120 hours post CRRT treatment initiation ]
  • Number, Location, and Duration of Bleeding Events [ Time Frame: Up to 120 hours post CRRT treatment initiation ]
  • Blood transfusions [ Time Frame: Up to 120 hours post CRRT treatment initiation ]
  • Adverse Events [ Time Frame: Up to 30 days post study CRRT treatment completion ]
  • Blood Pressure [ Time Frame: Baseline and up to 120 hours post CRRT treatment initiation ]
  • Respiratory Rate [ Time Frame: Baseline and up to 120 hours post CRRT treatment initiation ]
  • Temperature [ Time Frame: Baseline and up to 120 hours post CRRT treatment initiation ]
  • Pulse [ Time Frame: Baseline and up to 120 hours post CRRT treatment initiation ]

Estimated Enrollment: 160
Actual Study Start Date: September 13, 2016
Estimated Study Completion Date: June 30, 2020
Estimated Primary Completion Date: June 30, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prismocitrate 18 Drug: Prismocitrate 18
Modality of CVVHDF
Other Name: Regional Citrate Anticoagulation (RCA)
Active Comparator: No Regional Anticoagulation of CRRT Circuit Other: No Anticoagulation
Modality of CVVHDF

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860130


Contacts
Contact: Jennifer Arcaroli, MS jennifer_arcaroli@baxter.com

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Eric Judd, MD         
United States, Arizona
University of Arizona Recruiting
Tucson, Arizona, United States, 85724
Contact: Bijin Thajudeen, MD         
United States, California
UCLA Not yet recruiting
Los Angeles, California, United States, 90025
Contact: Anjay Rastogi, MD         
United States, Connecticut
Yale University School of Medicine Not yet recruiting
New Haven, Connecticut, United States, 06520
Contact: Justin Belcher, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Michael Connor, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Cybele Ghossein-Hoseen, MD         
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Jason Stubbs, MD         
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40526
Contact: Javier Neyra, MD         
United States, Maryland
University of Maryland Medical Center Not yet recruiting
Baltimore, Maryland, United States, 21201
Contact: Daniel Herr, MD         
United States, Massachusetts
Beth Israel Deaconess (Harvard) Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Bradley Denker, MD         
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Luis Juncos, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Sevag Demirjian, MD         
Canada, Alberta
University of Alberta Hospital Not yet recruiting
Edmonton, Alberta, Canada, T6G2B7
Contact: Sean Bagshaw, MD         
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Study Director: Qing Li, MD Baxter Healthcare Corporation
  More Information

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT02860130     History of Changes
Other Study ID Numbers: 1407-004
First Submitted: July 29, 2016
First Posted: August 9, 2016
Last Update Posted: October 20, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Baxter Healthcare Corporation:
Regional Citrate Anticoagulation (RCA)
Continuous Renal Replacement Therapy (CRRT)
Acute Kidney Injury

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Citric Acid
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action