Comparison of Potassium Binders in the ER

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    120
  • sponsor
    University of California, Irvine
Updated on 20 August 2021

Summary

Compare efficacy of 3 oral potassium binders (cation exchange resins) on lowering blood potassium, in patients presenting to the Emergency Room with acute hyperkalemia.

Description

Adult patients presenting to the Emergency Room at UC Irvine with plasma potassium >5.5 mEq/L (who meet inclusion/exclusion criteria and provide written informed consent) will be randomized to a one-time dose of one of the following oral medications:

  1. Sodium polystyrene sulfate (SPS)
  2. Patiromer (Veltassa)
  3. Sodium zirconium cyclosilicate (Lokelma)
  4. Nonspecific laxative: polyethylene glycol 3350 (MiraLax)

Participants will receive standard-of-care hyperkalemia therapy as well.

Blood potassium will be checked at 2 and 4 hours after dose of study drug. Participants will complete a symptom and palatability questionnaire at 4 hours.

The purpose of this research study is to determine the effects of various potassium binders (SPS, patiromer, zirconium) vs a non-specific laxative (MiraLax) in the Emergency Room for patients found to have elevated blood potassium > 5.5 mEq/L. Hyperkalemia is a fairly common electrolyte disorder with varying levels of severity. Moderate hyperkalemia is in the range 5.5-5.9 mEq/L while severe hyperkalemia is 6.0 mEq/L or if patient is symptomatic: muscle weakness/paralysis or with EKG changes (e.g., peaked T waves, widening QRS, arrhythmias including ventricular fibrillation or asystole). Hyperkalemia is most commonly associated with kidney insufficiency, metabolic acidosis, and the use of medications such as renin-angiotensin-aldosterone system inhibitors.

In an emergency, the main goal is to reverse adverse cardiac effects and shift potassium into cells using interventions such as insulin/glucose and albuterol. However, these are only temporary measures. To remove potassium from the body, agents or interventions that may be used include cation exchange resins (potassium binders), loop diuretics, or dialysis. For over 50 years the only available oral cation exchange resin has been sodium polystyrene sulfonate. In recent years, two new agents (patiromer and zirconium) have been approved by the FDA for chronic management of hyperkalemia.

The cation exchange resins have not been studied head-to-head for acute hyperkalemia. This is a critical knowledge gap since acute hyperkalemia poses a significant burden on the healthcare system. In claims data analysis of 80,000 patients, half with hyperkalemia and half without, the patients with hyperkalemia had 4 times higher rate of inpatient admissions, 7 times longer average length of stay, and 30-day hospital readmission rate 14.21% vs 9.86% in the non-hyperkalemia cohort. The findings from our study will help inform decision-making guidelines for the treatment of acute hyperkalemia.

Details
Condition Acute Hyperkalemia, Oral Potassium Binders
Treatment Patiromer, Polyethylene Glycol 3350, Sodium Zirconium Cyclosilicate, Sodium Polystyrene Sulfonate Oral Suspension [SPS]
Clinical Study IdentifierNCT04585542
SponsorUniversity of California, Irvine
Last Modified on20 August 2021

Eligibility

Yes No Not Sure

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)
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