Study on Insulin Aspart, Salbutamol, and Glucose for Treating Acute Hyperkalemia in Emergency Department Patients

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What is this study about?

This clinical trial is focused on studying the treatment of hyperkalemia, a condition characterized by high levels of potassium in the blood. The study will compare three different treatments: an intravenous infusion of insulin and dextrose (a type of sugar), a nebulized (inhaled) form of salbutamol (a medication often used to treat asthma), and a combination of both the insulin/dextrose infusion and nebulized salbutamol. The purpose of the study is to determine which treatment is most effective in reducing potassium levels in the blood within 60 minutes, particularly in emergency department settings.

Participants in the study will receive one of the three treatments. The study will monitor changes in their blood potassium levels at various intervals, including 60 minutes, 180 minutes, and 24 hours after treatment. The study will also observe any side effects, heart rhythm issues, or other cardiovascular events that may occur during the treatment period. The goal is to find the best first-line treatment for quickly lowering potassium levels in patients with hyperkalemia.

The trial will involve the use of NovoRapid and Humalog, both of which are forms of insulin, as well as salbutamol in two different formulations: SALBUTAMOL ARROW and SALBUTAMOL VIATRIS. Additionally, glucose will be used in the insulin/dextrose infusion. The study is designed to provide valuable information on the effectiveness and safety of these treatments in managing acute hyperkalemia.

1 joining the study

Upon arrival at the emergency department, eligibility is confirmed. This includes being over 18 years old and having a serum potassium level of 5.5 mmol/l or higher.

Written informed consent is required before participation.

2 treatment allocation

Participants are randomly assigned to one of three treatment groups: insulin/dextrose infusion, nebulized salbutamol, or a combination of both.

The objective is to reduce serum potassium concentration within 60 minutes.

3 administration of treatment

For the insulin/dextrose group, insulin aspart or insulin lispro is administered intravenously.

For the nebulized salbutamol group, salbutamol is administered via inhalation.

The combination group receives both treatments as described above.

4 monitoring and assessment

Serum potassium levels are measured at 60 minutes, 180 minutes, and 24 hours after treatment begins.

Monitoring includes checking for heart rhythm disorders and other potential adverse effects.

5 follow-up evaluations

Further assessments are conducted to determine the need for additional treatment or dialysis.

Electrocardiographic abnormalities and major cardiovascular events are monitored at specified intervals.

Who Can Join the Study?

Patient must be older than 18 years old.
Patient must be admitted to the emergency department.
Patient must have a local laboratory test showing a serum potassium level of 5.5 mmol/l or higher. Serum potassium level is a measure of the amount of potassium in your blood.
Patient must provide written informed consent before participating in the study. This means the patient agrees to join the study after being informed about what it involves.

Who Cannot Join the Study?

Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.
Patients who have any medical condition that the study specifically excludes, even if not listed here.
Patients who are unable to follow the study procedures or instructions.
Patients who have a history of allergic reactions to the medications used in the study.
Patients who are currently participating in another clinical trial.
Patients who are pregnant or breastfeeding, as the study may not be safe for them.
Patients with severe health conditions that could interfere with the study or put them at risk.
Patients who have been advised by their doctor not to participate in the study for any reason.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Hopital Saint Antoine	Paris	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Hopital Beaujon	Clichy	France
Czxnhu Hceeaxguyjp dwtbtedholws	Agen	France
Cbtvng Hbolyfgrhfq Rmtexceo Upitonphnbknu Dq Tpcef	Tours	France
Ckcq Db Nlull	Vandoeuvre Les Nancy	France
Cvfmfu Hifneprlpal Rpafbjtx Drqwrcwjhogmxz	Angers	France
Hanblpst Upmjtvuecnogdu Snbthelzuo &gyfkig Hogbdze dd Hyzdxeurmlv	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	20.12.2019

Trial locations

Investigated drugs:

Insulin/Dextrose Intravenous Infusion is a treatment used to lower high levels of potassium in the blood. In this trial, it is given through a vein to quickly reduce potassium levels in patients experiencing acute hyperkalemia. The combination of insulin and dextrose helps move potassium from the blood into the cells, thereby lowering the potassium level in the bloodstream.

Nebulized Salbutamol is a medication that is inhaled through a nebulizer to help reduce high potassium levels in the blood. Salbutamol is commonly used to treat breathing problems, but in this trial, it is used for its ability to help lower potassium levels by moving potassium into the cells.

Combination of Nebulized Salbutamol and Insulin/Dextrose Intravenous Infusion involves using both treatments together to lower potassium levels in the blood. This combination aims to enhance the effectiveness of each treatment by using both the inhaled salbutamol and the intravenous insulin/dextrose to quickly reduce potassium levels in patients with acute hyperkalemia.

Hyperkalemia – Hyperkalemia is a condition characterized by an elevated level of potassium in the blood. Potassium is an essential mineral that helps regulate nerve and muscle function, including the heart. When potassium levels become too high, it can disrupt normal cellular functions, particularly affecting the heart’s rhythm. Symptoms may include muscle weakness, fatigue, and palpitations. In severe cases, it can lead to more serious complications involving the heart and muscles. The condition can develop rapidly or gradually, depending on the underlying cause.

Trial ID:

2024-514889-40-00

Protocol code:

RC19_0048

NCT ID:

NCT04012138

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Insulin Aspart, Salbutamol, and Glucose for Treating Acute Hyperkalemia in Emergency Department Patients

What is this study about?

Who Can Join the Study?

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