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Low enrollment rate
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Compare efficacy of 3 oral potassium binders (cation exchange resins) on lowering blood potassium, in hospital patients with acute hyperkalemia.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polyethylene glycol 3350 (MiraLax) | Experimental | 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. |
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| Sodium polystyrene sulfonate (Kayexalate) | Experimental | 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). |
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| Patiromer (Veltassa) | Experimental | 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). |
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| Sodium zirconium cyclosilicate (Lokelma) | Experimental | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyethylene Glycol 3350 | Drug | Nonspecific laxative comparison group. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Blood Potassium Level at 2 Hours and 4 Hours Compared to Baseline (When Study Drug Was Administered) | The investigators will compare the change in blood potassium after administration of the study drug, in the acute setting. | Plasma potassium level measured at 2 and 4 hours after study drug was administered |
| Measure | Description | Time Frame |
|---|---|---|
| Length of ER or Hospital Stay | The investigators will compare length of ER or hospital stay associated with each study drug, obtained from medical chart review. | Up to 60 days after study drug was administered |
| Change in Calcium and Magnesium at 4 Hours After Baseline (When Study Drug Was Administered) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine Medical Center | Orange | California | 92868 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30865167 | Background | Leon SJ, Harasemiw O, Tangri N. New therapies for hyperkalemia. Curr Opin Nephrol Hypertens. 2019 May;28(3):238-244. doi: 10.1097/MNH.0000000000000500. | |
| 29725642 | Background | Betts KA, Woolley JM, Mu F, Xiang C, Tang W, Wu EQ. The Cost of Hyperkalemia in the United States. Kidney Int Rep. 2017 Nov 14;3(2):385-393. doi: 10.1016/j.ekir.2017.11.003. eCollection 2018 Mar. |
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IPD will not be shared. De-identified dataset can be made available to other researchers, please contact PI Dr. Lau.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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). |
| FG002 | 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). |
| FG003 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | randomized trial |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Blood Potassium Level at 2 Hours and 4 Hours Compared to Baseline (When Study Drug Was Administered) | The investigators will compare the change in blood potassium after administration of the study drug, in the acute setting. | Adults with plasma potassium ≥5.5 mEq/L were randomized into the four treatment groups. Temporizing interventions for hyperkalemia management were allowed per discretion of the treating physician. | Posted | Mean | Standard Deviation | mEq/L | Plasma potassium level measured at 2 and 4 hours after study drug was administered |
|
4 hours
Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Polyethylene Glycol 3350: Nonspecific laxative comparison group. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wei Ling Lau, MD | University of California Irvine | 714-456-5142 | wllau@uci.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 2, 2021 | Mar 12, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000595212 | polyethylene glycol 3350 |
| C003321 | polystyrene sulfonic acid |
| C568789 | patiromer |
| C000597310 | sodium zirconium cyclosilicate |
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Participants and ER physicians are blinded to study drug allocation.
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| Sodium Polystyrene Sulfonate Oral Suspension [SPS] | Drug | Potassium binder to treat hyperkalemia. |
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| Patiromer | Drug | Potassium binder to treat hyperkalemia. |
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| Sodium zirconium cyclosilicate | Drug | Potassium binder to treat hyperkalemia. |
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The investigators will compare the effect of each study drug on blood calcium, phosphorus and magnesium levels, in the acute setting. |
| Measured at 4 hours after study drug was administered |
| Number of Participants Reporting GI Side Effects | Participants 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). | 4 hours after study drug was administered |
| Number of Participants Requiring Dialysis Within 8 Hours After Study Drug Was Administered | The 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. | Within 8 hours of study drug being administered |
| 37016309 | Derived | Canas AE, Troutt HR, Jiang L, Tonthat S, Darwish O, Ferrey A, Lotfipour S, Kalantar-Zadeh K, Hanna R, Lau WL. A randomized study to compare oral potassium binders in the treatment of acute hyperkalemia. BMC Nephrol. 2023 Apr 5;24(1):89. doi: 10.1186/s12882-023-03145-x. |
| BG001 | 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). |
| BG002 | 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). |
| BG003 | 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). |
| BG004 | Total | Total of all reporting groups |
| Standard Deviation |
| Years |
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| Sex: Female, Male | randomized trial | Count of Participants | Participants |
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| Race (NIH/OMB) | randomized trial | Count of Participants | Participants |
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| OG001 | 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). |
| OG002 | 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). |
| OG003 | 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). |
|
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| Secondary | Length of ER or Hospital Stay | The investigators will compare length of ER or hospital stay associated with each study drug, obtained from medical chart review. | Posted | Median | Inter-Quartile Range | days | Up to 60 days after study drug was administered |
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| Secondary | Change in Calcium and Magnesium at 4 Hours After Baseline (When 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. | Posted | Mean | Standard Deviation | mg/dL | Measured at 4 hours after study drug was administered |
|
|
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| Secondary | Number of Participants Reporting GI Side Effects | Participants 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). | Posted | Count of Participants | Participants | 4 hours after study drug was administered |
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| Secondary | Number of Participants Requiring Dialysis Within 8 Hours After Study Drug Was Administered | The 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. | Posted | Count of Participants | Participants | Within 8 hours of study drug being administered |
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| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | 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). Sodium Polystyrene Sulfonate Oral Suspension [SPS]: Potassium binder to treat hyperkalemia. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG002 | 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). Patiromer: Potassium binder to treat hyperkalemia. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG003 | 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). Sodium zirconium cyclosilicate: Potassium binder to treat hyperkalemia. | 0 | 10 | 0 | 10 | 0 | 10 |
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| Change in magnesium at 4 hours |
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