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

Who is this study for? Patients with Hyperkalaemia
Status: Recruiting
Location: See all (16) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Agen Hospital
RECRUITING
Agen
Angers University Hospital
RECRUITING
Angers
Avicenne University Hospital
ACTIVE_NOT_RECRUITING
Bobigny
University Hospital, Clermont-Ferrand
RECRUITING
Clermont-ferrand
Louis Mourier Hospital
ACTIVE_NOT_RECRUITING
Colombes
University Hospital, Grenoble
RECRUITING
Grenoble
Nancy University Hospital
RECRUITING
Nancy
Nantes University Hospital
RECRUITING
Nantes
Nice University Hospital
ACTIVE_NOT_RECRUITING
Nice
La Pitié Salpêtrière University Hospital
RECRUITING
Paris
Lariboisiere Hospital
RECRUITING
Paris
Saint Antoine University Hospital
RECRUITING
Paris
Poitiers University Hospital
RECRUITING
Poitiers
Rennes University Hospital
RECRUITING
Rennes
Strasbourg University Hospital
ACTIVE_NOT_RECRUITING
Strasbourg
Tours University Hospital
RECRUITING
Tours
Contact Information
Primary
Emmanuel MONTASSIER
emmanuel.montassier@chu-nantes.fr
02 53 48 20 38
Time Frame
Start Date: 2019-12-20
Estimated Completion Date: 2026-06-20
Participants
Target number of participants: 525
Treatments
Experimental: Salbutamol
Patients in this experimental group will receive : 10 mg of salbutamol nebulized in 30 minutes (with oxygen 8 liters per minute or with air);
Active_comparator: Insuline + dextrose
Patients in the experimental group will receive : 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
Experimental: Insuline + Dextrose + Salbutamol
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.
Related Therapeutic Areas
Sponsors
Leads: Nantes University Hospital

This content was sourced from clinicaltrials.gov