Patiromer Utility as an Adjunct Treatment in Patients Needing Urgent Hyperkalemia Management

• Status: Recruiting
• Trial end date: 2022-08-15
• Target enrollment: 0
• Participant gender: All

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 superior to other. The purpose of this study is to help determine if a drug called patiromer (already approved by the FDA) can help lower potassium levels while patients are in the emergency department.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Comprehensive Research Associates

Criteria

Inclusion Criteria:

• Hyperkalemia, defined as K+ ≥5.8 obtained via local laboratory or point-of-care testing

• Written informed consent obtained.

Exclusion Criteria:

1. Clinically significant arrhythmia, defined as any arrhythmia requiring ongoing IV antiarrhythmic therapy.

2. 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

3. Hyperkalemia solely due to overdose on potassium supplements

4. Known bowel obstruction

5. 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

6. Subjects expected to receive dialysis during the first 6 hours of the study treatment period

7. Known hypersensitivity to patiromer or its ingredients

8. Participation in any other investigational device or drug study <30 days prior to screening, or current treatment with other investigational agent(s)

9. Inability to consume the investigational product or, in the opinion of the Investigator unsuitable for study participation

10. Life expectancy of less than 6 months

11. Patients with automatically timed medication orders to control potassium in the ED

12. Patient is known to be pregnant or breastfeeding

13. An employee of investigational site or sponsors