5 Versus 10 Units of Insulin in Hyperkalemia Management
NCT ID: NCT06036823
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
384 participants
INTERVENTIONAL
2023-10-01
2025-09-30
Brief Summary
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Detailed Description
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Method: This will be a multi-center, prospective, double-blind, non-inferiority, randomized control trial. 336 hyperkalemia patients will be randomized to the intervention group 5 units of intravenous Regular insulin and 10 units of intravenous insulin groups with fifty ml of Dextrose Fifty percent. They will be enrolled once their potassium level is 5.5mEq/L or more. The attending physician and patient will be blinded about the dose of insulin that the patient received. Serum potassium will be measured at 0 and at 120 minutes from the start of the medications. Random blood glucose will be measured at 0, 60, and 120 minutes by Glucometer. The safety of our patients will be assessed by documentation of all adverse events, vital signs, and clinical assessment before and after drug administration. The study will end at 2 hours from insulin administration.
Aim: Our research idea aims to compare two recommended doses of Insulin (5 Units vs. 10 Units of Regular insulin given intravenously over thirty minutes) in the management of patients with hyperkalemia.
Primary objective: Mean reduction in serum potassium level using the main laboratory results at two hours from medication administration.
Secondary objectives: effect of initial (baseline) potassium level on the mean potassium reduction, and frequency of hypoglycemia between the 2 groups. Does the initial (baseline) blood glucose level will affect the function of insulin/dextrose in lowering potassium levels?
Patient Population: Adult patients (Aged 18 years and older) who present to the Emergency department at Sultan Qaboos University, Royal Hospital and Sohar hospital for evaluation and are found to have potassium levels of 5.5 mEq/L and above.
Intervention: Single dose of 5 units of intravenous insulin over 30 minutes with 50 ml of Dextrose 50%.
Clinical Measurement: Mean reduction of potassium level using the main laboratory results at 2 hours from insulin/dextrose administration. Hypoglycemia will be followed by a bedside glucometer.
Outcome: reduction of potassium level at 2 hours from medication administration and medication safety.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
TRIPLE
Study Groups
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10 units of intravenous R insulin
Will Receive:
IV Insulin Regular 10 units with Dextrose 50 % 50 ml over 30 minutes. Salbutamol 10 mg nebulization over 15 minutes.
Insulin regular
Intravenous insulin
Dextrose 50
to be given to both arms
salbutamol
to be given to all patients
5 units of intravenous R insulin
Will receive:
IV Insulin Regular 5 units with Dextrose 50 % 50 ml over 30 minutes. Salbutamol 10 mg Nebulization over 15 minutes.
Insulin regular
Intravenous insulin
Dextrose 50
to be given to both arms
salbutamol
to be given to all patients
Interventions
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Insulin regular
Intravenous insulin
Dextrose 50
to be given to both arms
salbutamol
to be given to all patients
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Sultan Qaboos University
OTHER
Oman Medical Speciality Board
OTHER_GOV
Responsible Party
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Adnan Al-Ajmi
Doctor
Principal Investigators
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Suad Al-Abri
Role: PRINCIPAL_INVESTIGATOR
Sultan Qaboos University hospital
Locations
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Sultan Qaboos University hospital
Seeb, Muḩāfaz̧at Masqaţ, Oman
Countries
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References
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Verdier M, DeMott JM, Peksa GD. A comparison of insulin doses for treatment of hyperkalaemia in intensive care unit patients with renal insufficiency. Aust Crit Care. 2022 May;35(3):258-263. doi: 10.1016/j.aucc.2021.05.004. Epub 2021 Jun 21.
Ron M. Walls, MD. Hyperkalemia. Rosen emergency medince Concepts and Clinical practice. 9th. Philadelphia : Elsevier, 2018, 117, pp. 1516 - 1519.
Judith E. Tintinalli, MD, MS. Hyperkalemia. Tintinalli's Emergency Medicine a comprehensive study guide. 9th. s.l. : McGraw-Hill Education, 2020, 17, p. 89.
McNicholas BA, Pham MH, Carli K, Chen CH, Colobong-Smith N, Anderson AE, Pham H. Treatment of Hyperkalemia With a Low-Dose Insulin Protocol Is Effective and Results in Reduced Hypoglycemia. Kidney Int Rep. 2017 Oct 24;3(2):328-336. doi: 10.1016/j.ekir.2017.10.009. eCollection 2018 Mar.
Moussavi K, Nguyen LT, Hua H, Fitter S. Comparison of IV Insulin Dosing Strategies for Hyperkalemia in the Emergency Department. Crit Care Explor. 2020 Apr 29;2(4):e0092. doi: 10.1097/CCE.0000000000000092. eCollection 2020 Apr.
LaRue HA, Peksa GD, Shah SC. A Comparison of Insulin Doses for the Treatment of Hyperkalemia in Patients with Renal Insufficiency. Pharmacotherapy. 2017 Dec;37(12):1516-1522. doi: 10.1002/phar.2038. Epub 2017 Nov 27.
Moussavi K, Garcia J, Tellez-Corrales E, Fitter S. Reduced alternative insulin dosing in hyperkalemia: A meta-analysis of effects on hypoglycemia and potassium reduction. Pharmacotherapy. 2021 Jul;41(7):598-607. doi: 10.1002/phar.2596. Epub 2021 Jun 1.
Harel Z, Kamel KS. Optimal Dose and Method of Administration of Intravenous Insulin in the Management of Emergency Hyperkalemia: A Systematic Review. PLoS One. 2016 May 5;11(5):e0154963. doi: 10.1371/journal.pone.0154963. eCollection 2016.
Garcia J, Pintens M, Morris A, Takamoto P, Baumgartner L, Tasaka CL. Reduced Versus Conventional Dose Insulin for Hyperkalemia Treatment. J Pharm Pract. 2020 Jun;33(3):262-266. doi: 10.1177/0897190018799220. Epub 2018 Sep 6.
Provided Documents
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Document Type: Study Protocol and Informed Consent Form
Document Type: Statistical Analysis Plan
Related Links
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David B Mount, MD. Causes and evaluation of hyperkalemia in adults
Treatment and prevention of hyperkalemia in adults
Hyperkalemia Treatment \& Management
Hypoglycemia in adults without diabetes mellitus: Clinical manifestations, diagnosis, and causes
Hyper K recognition and treatment of Hyperkalemia in the ED. American College of Emergency Physicians.
Other Identifiers
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MREC #2779
Identifier Type: -
Identifier Source: org_study_id