Comparing two doses of insulin for treating high potassium levels
5 Versus 10 Units of Insulin in Hyperkalemia Management: Multi-center, Prospective, Double-blind, Non-inferiority, Randomized Control Trial.
This study is testing whether giving 5 units of insulin is just as effective as giving 10 units for lowering high potassium levels in adults.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 336 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oman Medical Speciality Board Government |
| Locations | 1 site (Seeb, Muscat) |
| Trial ID | NCT06036823 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of 5 units versus 10 units of intravenous regular insulin in managing hyperkalemia, a condition characterized by elevated potassium levels in the blood. It will be a multi-center, prospective, double-blind, non-inferiority, randomized control trial involving 336 adult patients with potassium levels of 5.5 mEq/L or higher. Participants will receive either dose of insulin along with dextrose, and their serum potassium levels will be measured at baseline and after 120 minutes to assess the efficacy of the treatment. The study will also monitor blood glucose levels and document any adverse events to ensure patient safety.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older with hyperkalemia, defined as a potassium level of 5.5 mEq/L or higher.
Not a fit: Patients experiencing cardiac arrest, severe hyperglycemia, or other acute complications related to diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could optimize insulin dosing for hyperkalemia management, potentially improving patient outcomes and safety.
How similar studies have performed: While there have been various approaches to managing hyperkalemia, this specific comparison of insulin doses is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Seeb, Muscat
- Sultan Qaboos University hospital — Seeb, Muscat, Oman (Recruiting)
Study contacts
- Principal investigator: Suad Al-Abri — Sultan Qaboos University hospital
- Study coordinator: Adnan Al-Ajmi, MD
- Email: r2124@resident.omsb.org
- Phone: 98880381
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.