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Comparison of Potassium Binders in the ER (KBindER)

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ClinicalTrials.gov Identifier: NCT04585542
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Wei Ling Lau, University of California, Irvine

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Hyperkalemia Oral Potassium Binders Drug: Polyethylene Glycol 3350 Drug: Sodium Polystyrene Sulfonate Oral Suspension [SPS] Drug: Patiromer Drug: Sodium zirconium cyclosilicate Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description: Participants and ER physicians are blinded to study drug allocation.
Primary Purpose: Treatment
Official Title: Comparison of Potassium Binders in the ER
Actual Study Start Date : October 20, 2020
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arm Intervention/treatment
Experimental: Polyethylene glycol 3350 (MiraLax)

Participants will be randomized to one of four study arms. They will receive one dose of the study drug.

One study arm is the nonspecific laxative MiraLax (one dose of 17g). Since constipation can contribute to hyperkalemia, this arm will study the effect of treating constipation instead of direct cation exchange for potassium in the gut.

Drug: Polyethylene Glycol 3350
Nonspecific laxative comparison group.
Other Name: MiraLax

Experimental: Sodium polystyrene sulfonate (Kayexalate)

Participants will be randomized to one of four study arms. They will receive one dose of the study drug.

The potassium binder drugs of interest include sodium polystyrene sulfonate (one dose of 30g), patiromer (one dose of 25.2g), and sodium zirconium cyclosilicate (one dose of 15g).

Drug: Sodium Polystyrene Sulfonate Oral Suspension [SPS]
Potassium binder to treat hyperkalemia.
Other Name: Kayexalate

Experimental: Patiromer (Veltassa)

Participants will be randomized to one of four study arms. They will receive one dose of the study drug.

The potassium binder drugs of interest include sodium polystyrene sulfonate (one dose of 30g), patiromer (one dose of 25.2g), and sodium zirconium cyclosilicate (one dose of 15g).

Drug: Patiromer
Potassium binder to treat hyperkalemia.
Other Name: Veltassa

Experimental: Sodium zirconium cyclosilicate (Lokelma)

Participants will be randomized to one of four study arms. They will receive one dose of the study drug.

The potassium binder drugs of interest include sodium polystyrene sulfonate (one dose of 30g), patiromer (one dose of 25.2g), and sodium zirconium cyclosilicate (one dose of 15g).

Drug: Sodium zirconium cyclosilicate
Potassium binder to treat hyperkalemia.
Other Name: Lokelma




Primary Outcome Measures :
  1. Change in blood potassium level [ Time Frame: Plasma potassium level measured at 2 and 4 hours after study drug was administered ]
    The investigators will compare the change in blood potassium after administration of the study drug, in the acute setting.


Secondary Outcome Measures :
  1. Length of ER or hospital stay [ Time Frame: Up to 60 days after study drug was administered ]
    The investigators will compare length of ER or hospital stay associated with each study drug, obtained from medical chart review.

  2. Change in calcium, phosphorus and magnesium [ Time Frame: Measured at 2 and 4 hours after study drug was administered ]
    The investigators will compare the effect of each study drug on blood calcium, phosphorus and magnesium levels, in the acute setting.

  3. Dialysis yes/no within 8 hours [ Time Frame: Within 8 hours of study drug being administered ]
    The investigators will assess whether dialysis was needed to manage hyperkalemia, and whether dialysis requirement was affected by the study drug given. This will be assessed from medical chart review.

  4. Palatability and side effects (patient subjective rating) [ Time Frame: 4 hours after study drug was administered ]
    Participants will complete a 1-page brief survey assessing for potential study drug side effects including bloating, nausea, diarrhea and palpitations (answers are yes/no). Participants will also rate the palatability of the study drug using a 1-5 scale, with 5 being the best score (most palatable and easy to swallow).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04585542


Contacts
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Contact: Wei Ling Lau, MD 714-456-5142 wllau@uci.edu

Locations
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United States, California
University of California, Irvine Medical Center Recruiting
Orange, California, United States, 92868
Contact: Wei Ling Lau, MD    714-456-5142    wllau@uci.edu   
Sponsors and Collaborators
University of California, Irvine
Publications:
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Responsible Party: Wei Ling Lau, Assistant Professor in Nephrology, Dpt of Medicine, University of California, Irvine
ClinicalTrials.gov Identifier: NCT04585542    
Other Study ID Numbers: HS# 2020-5780
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared. De-identified dataset can be made available to other researchers, please contact PI Dr. Lau.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Wei Ling Lau, University of California, Irvine:
Emergency Department
Additional relevant MeSH terms:
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Hyperkalemia
Water-Electrolyte Imbalance
Metabolic Diseases
Polyethylene glycol 3350
Polystyrene sulfonic acid
Laxatives
Gastrointestinal Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action