Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California
Dates
study started
estimated completion
Principal Investigator
by Wei Ling Lau

Description

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.

Details

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.

Keywords

Acute Hyperkalemia Oral Potassium Binders Emergency Department Hyperkalemia Polyethylene glycol 3350 Polystyrene sulfonic acid Sodium Polystyrene Sulfonate Oral Suspension [SPS] Patiromer Sodium zirconium cyclosilicate Polyethylene glycol 3350 (MiraLax) Sodium polystyrene sulfonate (Kayexalate) Patiromer (Veltassa) Sodium zirconium cyclosilicate (Lokelma)

Eligibility

You can join if…

Open to people ages 18 years and up

  • Plasma potassium > 5.5 mEq/L
  • Age ≥18 years
  • Patient able to provide written informed consent

You CAN'T join if...

  • 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)

Location

  • University of California, Irvine Medical Center accepting new patients
    Orange California 92868 United States

Lead Scientist at UC Irvine

  • Wei Ling Lau
    Assistant Health Sciences Professor, Medicine. Authored (or co-authored) 48 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT04585542
Phase
Phase 4
Study Type
Interventional
Last Updated