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RECRUITING
NCT04012138
PHASE4

Insulin Dextrose Infusion vs Nebulized Salbutamol vs Combination of Salbutamol and Insulin Dextrose in Acute Hyperkalemia

Sponsor: Nantes University Hospital

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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