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Insulin Dextrose Infusion vs Nebulized Salbutamol vs Combination of Salbutamol and Insulin Dextrose in Acute Hyperkalemia
Sponsor: Nantes University Hospital
Summary
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.
Official title: InSaKa Trial: Insulin Dextrose Infusion Versus Nebulized Salbutamol Versus Combination of Salbutamol and Insulin Dextrose in Acute Hyperkalemia: a Randomized Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
525
Start Date
2019-12-20
Completion Date
2026-06-20
Last Updated
2024-04-30
Healthy Volunteers
No
Conditions
Interventions
Salbutamol
10 mg of salbutamol nebulized in 30 minutes (with oxygen 8 liters per minute or with air) 10 units of regular insulin (rapid-acting, insuline asparte, intravenous injection) as an intravenous bolus with 500 ml of 10% dextrose in water administered over a 30-minute period.
Insulin Aspart
Patients in the experimental group will receive either: 1. 10 mg of salbutamol nebulized in 30 minutes (with oxygen 8 liters per minute or with air); OR 2. 10 units of regular insulin (rapid-acting, insuline asparte, intravenous injection) as an intravenous bolus with 500 ml of 10% dextrose in water administered over a 30-minute period plus 10 mg of salbutamol nebulized in 30 minutes (with oxygen 8 liters per minute or with air). The nurse will start by giving the 10 units of insulin and the dextrose, and then, immediately, she will start the nebulization of salbutamol.
Locations (16)
Agen Hospital
Agen, France
Angers University Hospital
Angers, France
Avicenne University Hospital
Bobigny, France
University Hospital, Clermont-Ferrand
Clermont-Ferrand, France
Louis Mourier Hospital
Colombes, France
University Hospital, Grenoble
Grenoble, France
Nancy University Hospital
Nancy, France
Nantes University Hospital
Nantes, France
Nice University Hospital
Nice, France
La Pitié Salpêtrière University Hospital
Paris, France
Lariboisiere Hospital
Paris, France
Saint Antoine University Hospital
Paris, France
Poitiers University Hospital
Poitiers, France
Rennes University Hospital
Rennes, France
Strasbourg University Hospital
Strasbourg, France
Tours University Hospital
Tours, France