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5 Versus [amount hidden] of Insulin in Hyperkalemia Management

Plain-language guide to NCT06036823: phase 4 randomized trial of Insulin (regular human), 384 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06036823
Phase
phase 4
Status
completed
Start
2023-10-01
Completion (planned or actual)
2025-09-30
Participants
384 (actual)
Design
randomized, triple-blind, treatment
Conditions studied
Hyperkalemia; Potassium Imbalance; Electrolyte Imbalance; Electrolyte Disturbance
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 4 trial, researchers set out to test Insulin (regular human).

It had two arms (groups): one (active comparator) and one (active comparator).

The registry classes the interventions as drug.

More on the Plan

Introduction: Hyperkalaemia is a serum Potassium (K) level of more than 5.5 mEq/L.

It is a common emergency medicine presentation and can be life-threatening.

Salbutamol inhalers, Glucose solutions, and Insulin are the main medications for managing hyperkalemia.

Insulin and Dextrose shift potassium ions into body cells by stimulating the sodium/potassium ATP pump.

Who Took Part

Enrollment: 384 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: Hyperkalemia patients with lab potassium levels equal to or more than 5.5 mEq/L (≥ 5.5 mEq/L)+. Adult: age 18 years or more. Agreed to participate in the study.

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: cardiac arrest; allergies for any medication in the protocol; hemolyzed potassium level as reported by the main lab.

How the Study Was Run

Design: randomized, factorial and triple-blind.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

As a double-blind Insulin (regular human) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2023-10-01 with completion listed for 2025-09-30.

It ran at 1 site in Oman.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 384 people.

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

More context: the Insulin (regular human) compound page, all human trials.

Our Notes on the Compound

Insulin (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.