Comparing potassium binders for treating high potassium levels in the ER
Comparison of Potassium Binders in the ER
This study is testing which of three different medications works best to lower high potassium levels in adults who come to the Emergency Room.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Irvine Academic / other |
| Locations | 1 site (Orange, California) |
| Trial ID | NCT04585542 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the efficacy of three oral potassium binders—sodium polystyrene sulfate, patiromer, and sodium zirconium cyclosilicate—against a non-specific laxative in patients presenting with acute hyperkalemia in the Emergency Room. Adult patients with plasma potassium levels greater than 5.5 mEq/L will be randomized to receive one of the medications, along with standard hyperkalemia therapy. Blood potassium levels will be monitored at 2 and 4 hours post-administration, and participants will complete a questionnaire regarding symptoms and medication palatability. The goal is to identify the most effective treatment for lowering potassium levels in this acute setting.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with elevated plasma potassium levels greater than 5.5 mEq/L who can provide informed consent.
Not a fit: Patients who may not benefit from this study include those with recent bowel surgery, active psychiatric disorders, or those requiring immediate dialysis.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with acute hyperkalemia, potentially improving patient outcomes in emergency situations.
How similar studies have performed: Other studies have explored the use of potassium binders, but this specific comparison of binders in an emergency setting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Plasma potassium \> 5.5 mEq/L * Age ≥18 years * Patient able to provide written informed consent Exclusion Criteria: * Recent bowel surgery * Ileus or bowel obstruction * Pseudohyperkalemia signs and symptoms, such as excessive fist clenching, hemolyzed blood specimen, severe leukocytosis or thrombocytosis * Pregnancy * Active psychiatric disorder * Diabetic ketoacidosis or hyperkalemia caused by any condition for which a therapy directed against the underlying cause of hyperkalemia would be a better treatment option * Dialysis session expected within 4 hours after randomization * History of hypersensitivity to sodium polystyrene sulfonate resin or patiromer * Concurrent use of sorbitol (due to increased risk of intestinal necrosis when used with sodium polystyrene sulfonate)
Where this trial is running
Orange, California
- University of California, Irvine Medical Center — Orange, California, United States (Recruiting)
Study contacts
- Study coordinator: Wei Ling Lau, MD
- Email: wllau@uci.edu
- Phone: 714-456-5142
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.