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When a patient arrives to an emergency department and is found to have an elevated potassium level in the blood, there is no one standardized treatment, therefore it is not known if one treatment is superior to other. The purpose of this study is to help determine if a drug called patiromer (already approved by the FDA) can help lower potassium levels while patients are in the emergency department.
Given the lack of consistency in hyperkalemia treatment in the ED and the high cost of emergent dialysis, there is a need for the development and systematic evaluation of a treatment protocol to shift potassium into the cells followed by the removal of potassium from the body with a potassium binder.. The present study will use a systematic approach to shifting potassium into the cells followed by binding potassium in the gastrointestinal tract in hyperkalemic patients presenting to the ED. Study subjects will receive patiromer or placebo to determine if patiromer reduces the need for additional medical intervention for the management of hyperkalemia in patients initially treated with IV and inhaled therapy in the ED.
Upon enrollment, patiromer will be administered at a dose selected because of its safety and efficacy shown in a pilot study named REDUCE.
Up to 300 patients will be enrolled and followed for up to 14 days, and potassium levels will be measured at pre-determined intervals to assess drug's impact. concomitant medications will be recorded to help determine if study drug helped, not just lower hyperkalemia, but also decrease the number of total interventions needed to reach a normal potassium level.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Veltassa | Active Comparator | 3 packets of study drug powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink while in the emergency department |
|
| Placebo | Placebo Comparator | 3 packets of study drug powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink while in the emergency department |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patiromer Powder for Oral Suspension [Veltassa] | Drug | Powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink |
|
| Measure | Description | Time Frame |
|---|---|---|
| The need for additional potassium-lowering medical interventions | Net clinical benefit (mean difference in number of interventions less change in serum potassium) | Duration of patient's emergency department visit, up to 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Potassium level trends after receiving study drug | Proportion of subjects without post-baseline potassium-related medical interventions at Hours 4, 6 and 8 | Up to 24 hours after study drug dose is given |
| Potassium level trends after receiving study drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States | ||
| Yale University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41730555 | Derived | Rafique Z, Safdar B, Duanmu Y, Boone S, Meltzer A, Bischof JJ, Robinson D, Budden J, Budd J, Quinn CM, Milliet C, Singer AJ, Soto K, Peacock F. Patiromer utility as an adjunct treatment in patients needing urgent hyperkalaemia management (PLATINUM): a randomised controlled trial in the emergency department. BMJ Open. 2026 Feb 23;16(2):e105103. doi: 10.1136/bmjopen-2025-105103. | |
| 37308268 |
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randomized, double-blinded, placebo-controlled parallel group
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| Placebo | Drug | Powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink |
|
|
Net clinical benefit at Hour 4 |
| 4 hours |
| Potassium level trends after receiving study drug | Number of post-baseline potassium-related medical interventions up until Hours 4, 6, and 8 and ED discharge | ED visit, up to 10 hours |
| Potassium level trends after receiving study drug | Proportion of subjects with sustained potassium reduction (defined as K+ ≤5.5 mEq/l and 4 hours without potassium-related medical intervention) at Hours 6 and 8 | 8 hours |
| Potassium level trends after receiving study drug | K+ 24 hours after ED discharge | Up to 24 hours after study drug dose is given |
| New Haven |
| Connecticut |
| 06519 |
| United States |
| Christiana Care | Newark | Delaware | 19718 | United States |
| George Washington University | Washington D.C. | District of Columbia | 20037 | United States |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
| Wayne State University | Detroit | Michigan | 48201 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Hennepin Healthcare Research Institute | Minneapolis | Minnesota | 55415 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Washington University of St Louis | St Louis | Missouri | 63110 | United States |
| Mt Sinai. Icahn School of Medicine | New York | New York | 10029 | United States |
| Maimonides Medical Center | New York | New York | 11219 | United States |
| Stony Brook University Hospital | Stony Brook | New York | 11794 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45219 | United States |
| Ohio State University. Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| JPS Health Network | Fort Worth | Texas | 76104 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| UT Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
| Derived |
| Rafique Z, Budden J, Quinn CM, Duanmu Y, Safdar B, Bischof JJ, Driver BE, Herzog CA, Weir MR, Singer AJ, Boone S, Soto-Ruiz KM, Peacock WF. Patiromer utility as an adjunct treatment in patients needing urgent hyperkalaemia management (PLATINUM): design of a multicentre, randomised, double-blind, placebo-controlled, parallel-group study. BMJ Open. 2023 Jun 12;13(6):e071311. doi: 10.1136/bmjopen-2022-071311. |
| ID | Term |
|---|---|
| D006947 | Hyperkalemia |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013535 | Suspensions |
| C568789 | patiromer |
| D000095485 | Bulk Drugs |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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