Study design of Real World Evidence for Treatment of Hyperkalemia in the Emergency Department (REVEAL-ED): a multicenter, prospective, observational study

다국어 초록 (Multilingual Abstract)

Objective Hyperkalemia affects up to 10% of hospitalized patients and, if left untreated, can lead to serious cardiac arrhythmias or death. Although hyperkalemia is frequently encountered in the emergency department (ED), and is potentially life-threatening, standard of care for the treatment is poorly defined, with little supporting evidence. The main objectives of this observational study are to define the overall burden of hyperkalemia in the ED setting, describe its causes, the variability in treatment patterns and characterize the effectiveness and safety of ED standard of care therapies used in the United States.
Methods This is an observational study evaluating the management of hyperkalemia in the ED. Two hundred and three patients who presented to the ED with a potassium value ≥5.5 mmol/L were enrolled in the study at 14 sites across the United States. Patients were treated per standard of care practices at the discretion of the patient’s physician. In patients who received a treatment for hyperkalemia, blood samples were drawn at pre-specified time points and serum potassium values were recorded. The change in potassium over 4 hours and the adverse events after standard of care treatment were analyzed.
Results and Conclusion This article describes the background, rationale, study design, and methodology of the REVEAL-ED (Real World Evidence for Treatment of Hyperkalemia in the Emergency Department) trial, a multicenter, prospective, observational study evaluating contemporary management of patients admitted to the ED with hyperkalemia.

참고문헌 (Reference)

1 Aggarwal S, "Trends in emergency room visits due to hyperkalemia in the United States" 18 : A386-, 2015

2 Einhorn LM, "The frequency of hyperkalemia and its significance in chronic kidney disease" 169 : 1156-1162, 2009

3 Krogager ML, "Short-term mortality risk of serum potassium levels in hypertension: a retrospective analysis of nationwide registry data" 38 : 104-112, 2017

4 An JN, "Severe hyperkalemia requiring hospitalization: predictors of mortality" 16 : R225-, 2012

5 Conway R, "Serum potassium levels as an outcome determinant in acute medical admissions" 15 : 239-243, 2015

6 Goyal A, "Serum potassium levels and mortality in acute myocardial infarction" 307 : 157-164, 2012

7 Surawicz B, "Relationship between electrocardiogram and electrolytes" 73 : 814-834, 1967

8 Fisch C, "Relation of electrolyte disturbances to cardiac arrhythmias" 47 : 408-419, 1973

9 Juurlink DN, "Rates of hyperkalemia after publication of the Randomized Aldactone Evaluation Study" 351 : 543-551, 2004

10 Grodzinsky A, "Prevalence and prognosis of hyperkalemia in patients with acute myocardial infarction" 129 : 858-865, 2016

11 Jain N, "Predictors of hyperkalemia and death in patients with cardiac and renal disease" 109 : 1510-1513, 2012

12 Shemer J, "Incidence of hyperkalemia in hospitalized patients" 19 : 659-661, 1983

13 Stevens MS, "Hyperkalemia in hospitalized patients" 32 : 177-180, 2000

14 Paice B, "Hyperkalaemia in patients in hospital" 286 : 1189-1192, 1983

15 Moore ML, "Hyperkalaemia in patients in hospital" 102 : 557-558, 1989

16 Freeman K, "Effects of presentation and electrocardiogram on time to treatment of hyperkalemia" 15 : 239-249, 2008

17 Mahoney BA, "Clase CM. Emergency interventions for hyperkalaemia" CD003235-, 2005

18 McMahon GM, "Association between hyperkalemia at critical care initiation and mortality" 38 : 1834-1842, 2012