CompletedPhase 4

5 Versus 10 Units of Insulin in Hyperkalemia Management

Oman384 participantsStarted 2023-10-01

Plain-language summary

The goal of this study is to compare 5 units of intravenous Regular insulin to 10 units of intravenous regular insulin in the management of hyperkalemia. We will measure the efficacy of these 2 doses of insulin in reducing hyperkalemia at 2 hours from administration using the main laboratory serum values.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. * If an investigator decides to start anti-hyperkalemia medications based on the VBG/ABG patient can be enrolled but if the main laboratory value is less than 5.5 mEq/L patients will be excluded Exclusion Criteria: * Cardiac arrest * Hyperglycemia with random blood sugar 20 mmol/L (13) or with acute diabetic complications like Diabetic Ketoacidosis / Hyperosmolar Hyperglycemic State. * Hypoglycemia with random blood sugar (RBS) ≤ 3.89 mmol/l in Diabetic patients and less than 3 mmol/l in non-diabetic patients. * Allergies for any medication in the protocol. * Pregnancy. * Hemolyzed potassium level as reported by the main lab. * Hemolysis, Tumor lysis syndrome, or Rhabdomyolysis due to the ongoing release of potassium. * Acidosis with a pH less than 7.1 will require Sodium bicarbonate (NaHO3). * A patient who will need urgent Furosemide (Lasix), and or dialysis during the study period of 2 hours. * Refused to participate.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To study the efficacy of two intravenous insulin doses (5 units and 10 units) in reducing serum potassium level in patients receiving hyperkalemia treatment using the main laboratory measurements. (the aim of reduction of 0.6 mmol/l +/- 0.2 mmol/L) (1).

Timeframe: At 2 hours from administration of medications

Trial details

NCT IDNCT06036823

SponsorOman Medical Speciality Board

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-09-30

View on ClinicalTrials.gov More Hyperkalemia trials