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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
115
Powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink
Powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink
Stanford University School of Medicine
Stanford, California, United States
Yale University
New Haven, Connecticut, United States
The need for additional potassium-lowering medical interventions
Net clinical benefit (mean difference in number of interventions less change in serum potassium)
Time frame: Duration of patient's emergency department visit, up to 6 hours
Potassium level trends after receiving study drug
Proportion of subjects without post-baseline potassium-related medical interventions at Hours 4, 6 and 8
Time frame: Up to 24 hours after study drug dose is given
Potassium level trends after receiving study drug
Net clinical benefit at Hour 4
Time frame: 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
Time frame: 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
Time frame: 8 hours
Potassium level trends after receiving study drug
K+ 24 hours after ED discharge
Time frame: Up to 24 hours after study drug dose is given
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