Comparison of Potassium Binders in the ER

HS# 2020-5780

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

2020-10-20

2024-07-01

2024-12-01

Recruiting

Early phase I

120

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)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Participants and ER physicians are blinded to study drug allocation.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

2023-10-27