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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.