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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

4 criteria

  • 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 trial?

9 criteria

  • 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.
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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.

What is already known about the treatment

  • Insulin Dextrose Infusion

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating acute hyperkalemia. It is commonly used in emergency settings to quickly lower high potassium levels in the blood. The mechanism involves insulin facilitating the uptake of potassium into cells, while dextrose prevents hypoglycemia by providing glucose. It is classified as a combination therapy involving a hormone (insulin) and a carbohydrate (dextrose).

  • Nebulized Salbutamol

    Administered through inhalation, this medication is under investigation for its role in managing acute hyperkalemia. It is traditionally used as a bronchodilator for asthma and other respiratory conditions. Salbutamol works by stimulating beta-2 adrenergic receptors, which helps move potassium into cells, thereby reducing blood potassium levels. It is classified as a beta-2 adrenergic agonist.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514889-40-00Protocol codeRC19_0048Estimated enrolment525 patientsSponsorCentre Hospitalier Universitaire De Nantes

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).