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

July 3, 2025 updated by: Vantive Health LLC
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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G2B7
        • University of Alberta Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of Arizona
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University School Of Medicine
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Kentucky
      • Lexington, Kentucky, United States, 40526
        • University of Kentucky
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess (Harvard)
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Prismocitrate 18
Drug: Prismocitrate 18
Modality of CVVHDF
Other Names:
  • Regional Citrate Anticoagulation (RCA)
Active Comparator: No Regional Anticoagulation of CRRT Circuit
Other: No Anticoagulation
Modality of CVVHDF

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to Occurrence of Selected Prismaflex® System Alarms/Conditions
Time Frame: Up to 120 hours post CRRT treatment initiation
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."
Up to 120 hours post CRRT treatment initiation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Systemic blood iCa concentrations
Baseline and up to 120 hours post CRRT treatment initiation
Extracorporeal Circuit Ionized Calcium by Hour
Time Frame: Up to 120 hours post CRRT treatment initiation
Post-filter blood iCa concentrations will only be measured in the Prismocitrate 18 arm. The extracorporeal circuit (post-filter).
Up to 120 hours post CRRT treatment initiation
Delivery of Prescribed CRRT Dose by Day
Time Frame: Up to 120 hours post CRRT treatment initiation
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.
Up to 120 hours post CRRT treatment initiation
Number of Investigator Site Facilities That Passed Prismocitrate 18 Training Assessment
Time Frame: Prior to study use of Prismocitrate 18
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.
Prior to study use of Prismocitrate 18
Change From Baseline in Serum Bicarbonate by Hour
Time Frame: Baseline and up to 120 hours post CRRT treatment initiation
Baseline and up to 120 hours post CRRT treatment initiation
Change From Baseline in pH by Hour
Time Frame: Baseline and up to 120 hours post CRRT treatment initiation
Baseline and up to 120 hours post CRRT treatment initiation
Change From Baseline in Base Excess by Hour
Time Frame: Baseline and up to 120 hours post CRRT treatment initiation
Baseline and up to 120 hours post CRRT treatment initiation
Change From Baseline in Blood Total Calcium Concentration by Hour
Time Frame: Baseline and up to 120 hours post CRRT treatment initiation
Baseline and up to 120 hours post CRRT treatment initiation
Change From Baseline in Serum Sodium by Hour
Time Frame: Baseline and up to 120 hours post CRRT treatment initiation
Baseline and up to 120 hours post CRRT treatment initiation
Change From Baseline in Serum Anion Gap by Hour
Time Frame: Baseline and up to 120 hours post CRRT treatment initiation
Baseline and up to 120 hours post CRRT treatment initiation
Change From Baseline in Serum Magnesium by Hour
Time Frame: Baseline and up to 120 hours post CRRT treatment initiation
Baseline and up to 120 hours post CRRT treatment initiation
Change From Baseline in Serum Phosphate by Hour
Time Frame: Baseline and up to 120 hours post CRRT treatment initiation
Baseline and up to 120 hours post CRRT treatment initiation
Change From Baseline in Serum Potassium by Hour
Time Frame: Baseline and up to 120 hours post CRRT treatment initiation
Baseline and up to 120 hours post CRRT treatment initiation
Change From Baseline in Serum Chloride by Hour
Time Frame: Baseline and up to 120 hours post CRRT treatment initiation
Baseline and up to 120 hours post CRRT treatment initiation
Number of Participants With Bleeding Events
Time Frame: Up to 120 hours post CRRT treatment initiation
Up to 120 hours post CRRT treatment initiation
Number of Participants by Number of Blood Transfusions
Time Frame: Up to 120 hours post CRRT treatment initiation
Up to 120 hours post CRRT treatment initiation
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
Up to 30 days post study CRRT treatment completion
Change From Baseline in Blood Pressure at Last Visit
Time Frame: Baseline and up to 120 hours post CRRT treatment initiation
Baseline and up to 120 hours post CRRT treatment initiation
Change From Baseline in Respiratory Rate at Last Visit
Time Frame: Baseline and up to 120 hours post CRRT treatment initiation
Baseline and up to 120 hours post CRRT treatment initiation
Change From Baseline in Temperature at Last Visit
Time Frame: Baseline and up to 120 hours post CRRT treatment initiation
Baseline and up to 120 hours post CRRT treatment initiation
Change From Baseline in Pulse at Last Visit
Time Frame: Baseline and up to 120 hours post CRRT treatment initiation
Baseline and up to 120 hours post CRRT treatment initiation
Change From Baseline in Total Calcium/iCa Ratio by Hour
Time Frame: Baseline and up to 120 hours post CRRT treatment initiation
Baseline and up to 120 hours post CRRT treatment initiation
Number of Bleeding Events by Location
Time Frame: Up to 120 hours post CRRT treatment initiation
Up to 120 hours post CRRT treatment initiation
Duration of Bleeding Events
Time Frame: Up to 120 hours post CRRT treatment initiation
Up to 120 hours post CRRT treatment initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vantive Health LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Baxter Healthcare Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 27, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 12, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 12, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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