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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Modality of CVVHDF
Modality of CVVHDF
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
Time to Occurrence of Selected Prismaflex® System Alarms/Conditions
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."
Time frame: Up to 120 hours post CRRT treatment initiation
Change From Baseline in Patient Ionized Calcium (iCa) by Hour
Systemic blood iCa concentrations
Time frame: Baseline and up to 120 hours post CRRT treatment initiation
Extracorporeal Circuit Ionized Calcium by Hour
Post-filter blood iCa concentrations will only be measured in the Prismocitrate 18 arm. The extracorporeal circuit (post-filter).
Time frame: Up to 120 hours post CRRT treatment initiation
Delivery of Prescribed CRRT Dose by Day
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.
Time frame: Up to 120 hours post CRRT treatment initiation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 2 more locations
Number of Investigator Site Facilities That Passed Prismocitrate 18 Training Assessment
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.
Time frame: 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
Change From Baseline in pH by Hour
Time frame: 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
Change From Baseline in Blood Total Calcium Concentration by Hour
Time frame: 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
Change From Baseline in Serum Anion Gap by Hour
Time frame: 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
Change From Baseline in Serum Phosphate by Hour
Time frame: 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
Change From Baseline in Serum Chloride by Hour
Time frame: 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
Number of Participants by Number of Blood Transfusions
Time frame: 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
Change From Baseline in Blood Pressure at Last Visit
Time frame: 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
Change From Baseline in Temperature at Last Visit
Time frame: 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
Change From Baseline in Total Calcium/iCa Ratio by Hour
Time frame: 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
Duration of Bleeding Events
Time frame: Up to 120 hours post CRRT treatment initiation