Real-world treatment of hyperkalemia among patients in emergency department in China (POETRY-E): A study protocol for multicenter, prospective, observational study

ObjectiveHyperkalemiaF is associated with fatal cardiac arrhythmias, all-cause mortality, and frequent emergency department visits among patients with hyperkalemia. A recent Chinese epidemiological study suggested that the severity of hyperkalemia increases with comorbidities. Diagnosis, testing, and overall management of patients with hyperkalemia in the emergency department require strengthening. However, the lack of evidence from the emergency department and consensus guidelines has led to poorly characterized treatment patterns for hyperkalemia. The present study will evaluate the real-world effectiveness of different treatment options among patients with hyperkalemia in the emergency department across China.MethodsThis multicenter, prospective, observational study plans to collect primary data from 600 patients diagnosed with hyperkalemia who present to the emergency department in 15-20 tertiary hospitals across China. Patients aged ≥18 years with serum potassium levels ≥5.5 mmol/L will be included. Patients previously enrolled in any other clinical study within 3 months before enrollment will be excluded. Eligible patients will be enrolled, assessed at baseline, and followed up until discharge from the emergency department or death. The primary objective will be to determine the real-world effectiveness of potassium-lowering treatment (monotherapy/combination therapy), calculated as the mean change in serum potassium levels from baseline to 5 ± 1 h after treatment initiation. The secondary objectives will assess the clinical burden, calculated as the number of patients with baseline serum potassium levels ((5.5, 6.0), (6.0, 6.5), (6.5, 7.0), and (≥7.0) mmol/L), real-world treatment patterns, serum potassium testing, and the duration between baseline testing and treatment initiation. Exploratory objectives will further evaluate clinical outcomes among patients with different baseline serum potassium levels as described above and the proportion of patients recovering to normal serum potassium levels.DiscussionThe POETRY-E study is the first prospective observational study to evaluate the real-world effectiveness of different potassium-lowering treatment regimens among patients with hyperkalemia in the Chinese emergency department setting. This study addresses the overall burden and management among patients with hyperkalemia in China.Trial registration: Name of the Registry: Chinese Clinical Trial RegistryRegistration Number: ChiCTR2100053100.