- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02860130
Clinical Evaluation of Use of Prismocitrate 18 in Patients Undergoing Acute Continuous Renal Replacement Therapy (CRRT)
December 9, 2020 updated by: Baxter Healthcare Corporation
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Edmonton, Alberta, Canada, t6g2b7
- University of Alberta Hospital
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Alabama
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Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham
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Arizona
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Tucson, Arizona, United States, 85724
- University of Arizona
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Connecticut
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New Haven, Connecticut, United States, 06520
- Yale University School of Medicine
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
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Kentucky
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Lexington, Kentucky, United States, 40526
- University of Kentucky
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland Medical Center
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess (Harvard)
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Mississippi
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Jackson, Mississippi, United States, 39216
- University of Mississippi Medical Center
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Prismocitrate 18
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Modality of CVVHDF
Other Names:
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Active Comparator: No Regional Anticoagulation of CRRT Circuit
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Modality of CVVHDF
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Time to Occurrence of Selected Prismaflex® System Alarms/Conditions
Time Frame: Up to 120 hours post CRRT treatment initiation
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The point estimate is time point (number of hours of the extracorporeal circuit life of a filter) at which (100-percentile)% filters are still surviving (i.e.
number surviving divided by number at risk), based on the Kaplan-Meier method.
For example, for the 25th percentile: after 33.18 hours, 75% of filters are still surviving.
Given the early termination, this study was not powered to show statistically significant changes in efficacy endpoints.
The Prismaflex M150 Set extracorporeal circuit life of filters were intended to be assessed over a maximum of 120 hours (Treatment Period) by duration of time for which each Prismaflex M150 Set could be used continuously over a maximum 72 hour time-period in each patient.
The end of the extracorporeal circuit life was defined by the occurrence of one or both of the following Prismaflex® System alarms/conditions if the alarms could not be mitigated: (1) "Warning: Filter Clotted", and/or (2) "Advisory transmembrane pressure (TMP) Too High."
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Up to 120 hours post CRRT treatment initiation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Patient Ionized Calcium (iCa) by Hour
Time Frame: Baseline and up to 120 hours post CRRT treatment initiation
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Systemic blood iCa concentrations
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Baseline and up to 120 hours post CRRT treatment initiation
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Extracorporeal Circuit Ionized Calcium by Hour
Time Frame: Up to 120 hours post CRRT treatment initiation
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Post-filter blood iCa concentrations will only be measured in the Prismocitrate 18 arm.
The extracorporeal circuit (post-filter).
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Up to 120 hours post CRRT treatment initiation
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Delivery of Prescribed CRRT Dose by Day
Time Frame: Up to 120 hours post CRRT treatment initiation
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Evaluates the efficacy of using Prismocitrate 18 in delivering the prescribed CRRT dose, with delivered dose based on (daily) average effluent rate divided by (daily) average weight and expressed as mL/kg/hour.
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Up to 120 hours post CRRT treatment initiation
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Number of Investigator Site Facilities That Passed Prismocitrate 18 Training Assessment
Time Frame: Prior to study use of Prismocitrate 18
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Training conducted on administration of Prismocitrate 18 to demonstrate the understanding of the user groups on how to use the solution by passing an assessment at the end of training.
The user groups who needed to be assessed prior to use of Prismocitrate 18 in the clinical trial setting were to be comprised of physicians, nurses, and other clinicians who were part of prescribing, initiating or modifying treatment during the 120 hour Treatment Period.
The training assessment was housed on a restricted access study website.
Study personnel who completed the training assessment have a completion date listed which indicates that the individual received a passing score of 80% or better on the training assessment.
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Prior to study use of Prismocitrate 18
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Change From Baseline in Serum Bicarbonate by Hour
Time Frame: Baseline and up to 120 hours post CRRT treatment initiation
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Baseline and up to 120 hours post CRRT treatment initiation
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Change From Baseline in pH by Hour
Time Frame: Baseline and up to 120 hours post CRRT treatment initiation
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Baseline and up to 120 hours post CRRT treatment initiation
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Change From Baseline in Base Excess by Hour
Time Frame: Baseline and up to 120 hours post CRRT treatment initiation
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Baseline and up to 120 hours post CRRT treatment initiation
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Change From Baseline in Blood Total Calcium Concentration by Hour
Time Frame: Baseline and up to 120 hours post CRRT treatment initiation
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Baseline and up to 120 hours post CRRT treatment initiation
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Change From Baseline in Serum Sodium by Hour
Time Frame: Baseline and up to 120 hours post CRRT treatment initiation
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Baseline and up to 120 hours post CRRT treatment initiation
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Change From Baseline in Serum Anion Gap by Hour
Time Frame: Baseline and up to 120 hours post CRRT treatment initiation
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Baseline and up to 120 hours post CRRT treatment initiation
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Change From Baseline in Serum Magnesium by Hour
Time Frame: Baseline and up to 120 hours post CRRT treatment initiation
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Baseline and up to 120 hours post CRRT treatment initiation
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Change From Baseline in Serum Phosphate by Hour
Time Frame: Baseline and up to 120 hours post CRRT treatment initiation
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Baseline and up to 120 hours post CRRT treatment initiation
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Change From Baseline in Serum Potassium by Hour
Time Frame: Baseline and up to 120 hours post CRRT treatment initiation
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Baseline and up to 120 hours post CRRT treatment initiation
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Change From Baseline in Serum Chloride by Hour
Time Frame: Baseline and up to 120 hours post CRRT treatment initiation
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Baseline and up to 120 hours post CRRT treatment initiation
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Number of Participants With Bleeding Events
Time Frame: Up to 120 hours post CRRT treatment initiation
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Up to 120 hours post CRRT treatment initiation
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Number of Participants by Number of Blood Transfusions
Time Frame: Up to 120 hours post CRRT treatment initiation
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Up to 120 hours post CRRT treatment initiation
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Number of Participants Reporting Any Baxter Device/Product Related Adverse Events (Serious and Non-Serious)
Time Frame: Up to 30 days post study CRRT treatment completion
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Up to 30 days post study CRRT treatment completion
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Change From Baseline in Blood Pressure at Last Visit
Time Frame: Baseline and up to 120 hours post CRRT treatment initiation
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Baseline and up to 120 hours post CRRT treatment initiation
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Change From Baseline in Respiratory Rate at Last Visit
Time Frame: Baseline and up to 120 hours post CRRT treatment initiation
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Baseline and up to 120 hours post CRRT treatment initiation
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Change From Baseline in Temperature at Last Visit
Time Frame: Baseline and up to 120 hours post CRRT treatment initiation
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Baseline and up to 120 hours post CRRT treatment initiation
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Change From Baseline in Pulse at Last Visit
Time Frame: Baseline and up to 120 hours post CRRT treatment initiation
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Baseline and up to 120 hours post CRRT treatment initiation
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Change From Baseline in Total Calcium/iCa Ratio by Hour
Time Frame: Baseline and up to 120 hours post CRRT treatment initiation
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Baseline and up to 120 hours post CRRT treatment initiation
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Number of Bleeding Events by Location
Time Frame: Up to 120 hours post CRRT treatment initiation
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Up to 120 hours post CRRT treatment initiation
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Duration of Bleeding Events
Time Frame: Up to 120 hours post CRRT treatment initiation
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Up to 120 hours post CRRT treatment initiation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Qing Li, MD, Baxter Healthcare Corporation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 27, 2016
Primary Completion (Actual)
May 12, 2018
Study Completion (Actual)
May 12, 2018
Study Registration Dates
First Submitted
July 29, 2016
First Submitted That Met QC Criteria
August 5, 2016
First Posted (Estimate)
August 9, 2016
Study Record Updates
Last Update Posted (Actual)
January 5, 2021
Last Update Submitted That Met QC Criteria
December 9, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1407-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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