Status:
TERMINATED
Patiromer Utility as an Adjunct Treatment in Patients Needing Urgent Hyperkalemia Management
Lead Sponsor:
Comprehensive Research Associates
Conditions:
Hyperkalemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
When a patient arrives to an emergency department and is found to have an elevated potassium level in the blood, there is no one standardized treatment, therefore it is not known if one treatment is s...
Detailed Description
Given the lack of consistency in hyperkalemia treatment in the ED and the high cost of emergent dialysis, there is a need for the development and systematic evaluation of a treatment protocol to shift...
Eligibility Criteria
Inclusion
- Hyperkalemia, defined as K+ ≥5.8 obtained via local laboratory or point-of-care testing
- Written informed consent obtained.
Exclusion
- Clinically significant arrhythmia, defined as any arrhythmia requiring ongoing IV antiarrhythmic therapy.
- Patients who are hemodynamically unstable, defined as mean arterial pressure ≤65 mmHg or heart rate ≤40 beats per minute or ≥125 beats per minute at time of screening
- Hyperkalemia solely due to overdose on potassium supplements
- Known bowel obstruction
- Subjects currently being treated with or having taken potassium binders (e.g., patiromer, sodium or calcium polystyrene sulfonate or sodium zirconium cyclosilicate) in the 7 days prior to baseline
- Subjects expected to receive dialysis during the first 6 hours of the study treatment period
- Known hypersensitivity to patiromer or its ingredients
- Participation in any other investigational device or drug study \<30 days prior to screening, or current treatment with other investigational agent(s)
- Inability to consume the investigational product or, in the opinion of the Investigator unsuitable for study participation
- Life expectancy of less than 6 months
- Patients with automatically timed medication orders to control potassium in the ED
- Patient is known to be pregnant or breastfeeding
- An employee of investigational site or sponsors
Key Trial Info
Start Date :
October 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 3 2023
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT04443608
Start Date
October 8 2020
End Date
June 3 2023
Last Update
August 31 2023
Active Locations (19)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305
2
Yale University
New Haven, Connecticut, United States, 06519
3
Christiana Care
Newark, Delaware, United States, 19718
4
George Washington University
Washington D.C., District of Columbia, United States, 20037