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

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Aspart.

Hyperkalemia is a common electrolyte disorder, especially among patients with chronic kidney disease, diabetes mellitus, or heart failure.

Hyperkalemia is a potentially life-threatening electrolyte disturbance that can be fatal if left untreated.

It had three arms (groups): Salbutamol (experimental), Insuline + dextrose (active comparator) and Insuline + Dextrose + Salbutamol (experimental).

The registry classes the interventions as drug.

More on the Plan

Eligible patients will be recruited in the emergency department and included in the study after testing for inclusion and non-inclusion criteria.

The protocol will be approved by the ethical committee (random allocation) of the IRB.

All patients will provide written informed consent and the study will be performed in accordance with the International Conference on Harmonization Guidelines for Good Clinical Practice.

All electrocardiograms will be read at a core electrocardiographic laboratory.

Who Took Part

Enrollment: 419 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patient older than 18 years old. Patient admitted to the emergency department,. Patient who provide written informed consent prior to participation in the study.

The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: hemolysis or thrombocytosis \> 106/mm3 or hyperleukocytosis \> 105/mm3 on the first blood sample suspecting a pseudohyperkalemia,; diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome,; patient expected to require emergency intubation and ventilation,.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin Aspart and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Insulin Aspart was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2019-12-20 with completion listed for 2025-12-20.

It ran at 16 sites in France (16).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mean change in the absolute serum potassium level from baseline to 60 minutes (time frame: 60 minutes).

It also tracked 7 secondary outcomes, for example Mean change in the serum potassium level from baseline to 180 minutes and 24 hours, Proportion of patients who require re-treatment or dialysis at 60, 180 minutes and 24 hours, Proportion of patients with adverse effects at 60 and 180 minutes, Proportion of patients with electrocardiographic abnormalities, at 60, 180 minutes and 24 hours and Proportion of major cardiovascular events at 60, 180 minutes and 24 hours.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart in 419 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Aspart compound page, all human trials.