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Comparison of Potassium Binders in the ER

Comparison of Potassium Binders in the ER

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04585542
Acronym
KBindER
Enrollment
37
Registered
2020-10-14
Start date
2020-10-20
Completion date
2025-01-31
Last updated
2026-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Hyperkalemia, Oral Potassium Binders

Keywords

Emergency Department

Brief summary

Compare efficacy of 3 oral potassium binders (cation exchange resins) on lowering blood potassium, in hospital patients with acute hyperkalemia.

Detailed description

Adult patients presenting to the Emergency Room or currently hospitalized at UC Irvine (not in ICU level of care) 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 hospital 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.

Interventions

DRUGPolyethylene Glycol 3350

Nonspecific laxative comparison group.

DRUGSodium Polystyrene Sulfonate Oral Suspension [SPS]

Potassium binder to treat hyperkalemia.

Potassium binder to treat hyperkalemia.

Potassium binder to treat hyperkalemia.

Sponsors

University of California, Irvine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Masking description

Participants and ER physicians are blinded to study drug allocation.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in Blood Potassium Level at 2 Hours and 4 Hours Compared to Baseline (When Study Drug Was Administered)Plasma potassium level measured at 2 and 4 hours after study drug was administeredThe investigators will compare the change in blood potassium after administration of the study drug, in the acute setting.

Secondary

MeasureTime frameDescription
Length of ER or Hospital StayUp to 60 days after study drug was administeredThe investigators will compare length of ER or hospital stay associated with each study drug, obtained from medical chart review.
Change in Calcium and Magnesium at 4 Hours After Baseline (When Study Drug Was Administered)Measured at 4 hours after study drug was administeredThe investigators will compare the effect of each study drug on blood calcium, phosphorus and magnesium levels, in the acute setting.
Number of Participants Reporting GI Side Effects4 hours after study drug was administeredParticipants completed a 1-page brief survey assessing for potential GI side effects with the study drug including bloating, nausea and diarrhea (answers are yes/no).
Number of Participants Requiring Dialysis Within 8 Hours After Study Drug Was AdministeredWithin 8 hours of study drug being administeredThe investigators will assess whether dialysis was needed to manage hyperkalemia, within 8 hours of the study drug being given. This will be assessed from medical chart review.

Countries

United States

Baseline characteristics

Characteristic
Age, Continuous66 Years
STANDARD_DEVIATION 19
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
2 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
33 Participants
Sex: Female, Male
Female
2 Participants
Sex: Female, Male
Male
6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 80 / 90 / 100 / 10
other
Total, other adverse events
0 / 80 / 90 / 100 / 10
serious
Total, serious adverse events
0 / 80 / 90 / 100 / 10

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 23, 2026