5 Versus 10 Units of Insulin in Hyperkalemia Management

NCT06036823 | Completed Phase 4

• 1 other identifier: MREC #2779
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Potassium Imbalance; Electrolyte Imbalance; Electrolyte Disturbance; Hyperkalemia

Keywords

insulin; hyperkalemia; hypoglycmiea; anti-hyperkalemia; electrolytes abnormalities

Outcome Measures

Primary Outcomes (1)

• 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).

  Once the baseline potassium identified 5.5 mmol/L or more patient will be enrolled after taken an informed consent. Blood sample will be collected and send to the main laboratory for analysis at two hours from medications administration. The efficacy of the 2 doses of insulin in reducing potassium level will be measured at 2 hours from administration of medications by comparing the amount of changes of potassium level at two hours from baseline level. \- The main laboratory result will be used to measure and follow the patients. results will be reported in mmol/L.

  At 2 hours from administration of medications

Secondary Outcomes (3)

• Study the mean difference of the response to the anti-hyperkalemic measures based on the level of initial potassium (serum potassium before given any medications - At baseline).

  2 hours from administration of medications

• Association of mean potassium reduction with initial blood sugar level on potassium reduction

  2 hours from administration of medications

• Incidence of hypoglycemia (random blood sugar (RBS) ≤ 3.89 mmol/l in Diabetic patients and less than 3 mmol/l in non-diabetic patients) (12) and risk factor Characteristics of patients with a higher risk of developing hypoglycemia

  2 hours from administration of medications

Study Arms (2)

5 units of intravenous R insulin

ACTIVE COMPARATOR

Will receive: IV Insulin Regular 5 units with Dextrose 50 % 50 ml over 30 minutes. Salbutamol 10 mg Nebulization over 15 minutes.

Drug: Insulin regular; Drug: Dextrose 50; Drug: salbutamol

10 units of intravenous R insulin

ACTIVE COMPARATOR

Will Receive: IV Insulin Regular 10 units with Dextrose 50 % 50 ml over 30 minutes. Salbutamol 10 mg nebulization over 15 minutes.

Drug: Insulin regular; Drug: Dextrose 50; Drug: salbutamol

Interventions

Dextrose 50 DRUG

to be given to both arms

10 units of intravenous R insulin; 5 units of intravenous R insulin

salbutamol DRUG

to be given to all patients

10 units of intravenous R insulin; 5 units of intravenous R insulin

Insulin regular DRUG

Intravenous insulin

10 units of intravenous R insulin; 5 units of intravenous R insulin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sultan Qaboos University: collaborator
• Oman Medical Speciality Board: lead

Study Sites (1)

Sultan Qaboos University hospital

Seeb, Muḩāfaz̧at Masqaţ, 123, Oman

Location

Related Publications (9)

• 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.

  PMID: 34167889 BACKGROUND

• Ron M. Walls, MD. Hyperkalemia. Rosen emergency medince Concepts and Clinical practice. 9th. Philadelphia : Elsevier, 2018, 117, pp. 1516 - 1519.

  BACKGROUND

• Judith E. Tintinalli, MD, MS. Hyperkalemia. Tintinalli's Emergency Medicine a comprehensive study guide. 9th. s.l. : McGraw-Hill Education, 2020, 17, p. 89.

  BACKGROUND

• 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.

  PMID: 29725636 BACKGROUND

• 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.

  PMID: 32426734 BACKGROUND

• 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.

  PMID: 28976587 BACKGROUND

• 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.

  PMID: 33993515 BACKGROUND

• 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.

  PMID: 27148740 BACKGROUND

• 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.

  PMID: 30189765 BACKGROUND

Related Links

• 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.

MeSH Terms

Conditions

Hyperkalemia; Insulin Resistance

Interventions

Insulin; Albuterol

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism; Glucose Metabolism Disorders

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Suad Al-Abri

  Sultan Qaboos University hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: after consent. the care provider will take an envelope and give it to the nurse in charge of that patient without looking for the dose of insulin. as the same time will take the randomization code and stick it to the data collection sheet of that patient.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: the study group will receive 5 units of intravenous insulin control group will receive 10 unites of IV insulin

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: September 14, 2023
• Study Start: October 1, 2023
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

OM (1)