InSaKa Trial: Insulin Dextrose Infusion Versus Nebulized Salbutamol Versus Combination of Salbutamol and Insulin Dextrose in Acute Hyperkalemia: a Randomized Clinical Trial

RC19_0048

Hyperkalemia is a common electrolyte disorder, especially among patients with chronic kidney disease, diabetes mellitus, or heart failure. Globally, the reported incidence of hyperkalemia varies from 1.1 to 10 per 100 hospitalizations, depending on the patient cohort and comorbidities. Hyperkalemia is a potentially life-threatening electrolyte disturbance that can be fatal if left untreated. Several studies have established the association between hyperkalemia and all-cause mortality. Because of the deleterious cardiac effects of hyperkalemia, its management is an emergency intervention. However, robust evidence is lacking to guide the emergency management of patients with hyperkalemia. Emergency treatment approaches are largely based on small studies, anecdotal experience, and traditionally accepted practice patterns within institutions. Therefore, a rigorous evaluation of the first-line treatments of hyperkalemia in emergency departments is needed and a large scale randomized clinical trial is warranted before robust recommendations for clinical practice can be made. Our clinical trial will improve the safety of patients with acute hyperkalemia and will help clinicians in their day by day practice to choose the treatment that significantly reduces morbidity and mortality during acute hyperkalemia management. Our results will be delivered in a timely fashion, owing to the high prevalence of hyperkalemia in the emergency department setting and to the commitment of the INI-CRCT network of Excellence, along with ED specialists used to work jointly. the primary objective of our trial is to compare insulin/dextrose intravenous infusion, nebulized salbutamol or combination of nebulized salbutamol and insulin/dextrose intravenous infusion to reduce serum potassium concentration at 60 minutes, as first-line treatment, in emergency departments.

2019-12-20

2025-12-20

2026-06-20

Recruiting

Early phase I

525

Inclusion Criteria: * Patient older than 18 years old * Patient admitted to the emergency department, * Patient with local laboratory serum potassium level superior or equal to 5,5 mmol/l, * Patient who provide written informed consent prior to participation in the study Exclusion Criteria: * Hemolysis or thrombocytosis \> 106/mm3 or hyperleukocytosis \> 105/mm3 on the first blood sample suspecting a pseudohyperkalemia, * Diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome, * Pregnant or lactating woman, women with childbearing potential who didn't have effective contraception\*, * Patient expected to require emergency intubation and ventilation, * Patient expected to require dialysis, diuretics or bicarbonate within the first 60 minutes, * Patient with heart rhythm disorders or high grade atrioventricular bloc who require urgent medication as soon as admission or serum potassium level result, * Hypersensitivity to the tested active substance or excipients, * Acute coronary syndrome, * Patient not affiliated to a health insurance plan, * Patient under guardianship, curatorship or safeguard of justice. * The contraceptives considered as highly effective and acceptable by CTFG recommendations will be considered effective under this protocol. The list of contraceptives considered as highly effective and acceptable by CTFG recommendations is detailed in Appendix 7

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2024-04-30