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

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.

Conditions

• Hyperkalemia

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.

Sponsors & Collaborators

• Nantes University Hospital

  lead OTHER

Principal Investigators

• Julie CONTENTI · Nice University Hopsital

• Pierre-Clément THIEBAUD · Saint Antoine University Hospital

• Maxime MAIGNAN · University Hospital, Grenoble

• Jeannot SCHMIDT · University Hospital, Clermont-Ferrand

• Meïssa KARE · Agen Hospital

• Tahar CHOUIHED · Central Hospital, Nancy, France

• Anne-Laure FERAL-PIERSSENS · Avicenne University Hospital

• Florent MAILLET · Louis Mourier Hospital

• Yonathan FREUND · La Pitié Salpetrière University Hospital

• Nicolas MARJANOVIC · Poitiers University Hospital

• delphine DOUILLET · University Hospital, Angers

• Paul-Louis MARTIN · Tours University Hospital

• Pierrick LE BORGNE · University Hospital, Strasbourg, France

• Xavier EYER · Hopital Lariboisière

• Nicolas PESCHANSKI · Rennes University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-12-20

Primary Completion

2025-12-20

Completion

2025-12-20

Countries

• France

Study Locations