A Phase 4 interventional study of Insulin regular and Dextrose 50 in Hyperkalemia, Potassium Imbalance and Electrolyte Imbalance, sponsored by Oman Medical Speciality Board. Completed at 1 site in Oman. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-22.
Sponsored by Oman Medical Speciality Board · Phase 4, Interventional, and Treatment
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.
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. Because of the emergency in correcting hyperkalemia, different medications are used to reduce high potassium levels to normal as soon as possible. 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. Its effect starts in less than fifteen minutes and can last up to sixty minutes. It usually reduces potassium up to 1.1 mEq/l. There are different recommendations for Insulin dose and rate of administration for patients with hyperkalemia.
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.
133 studies on the registry are indexed under Hyperkalemia; 25 are open to participants now.
This study's enrollment of 384 is above the median of 87 across 102 interventional studies indexed under Hyperkalemia.
Browse Hyperkalemia studies →Oman Medical Speciality Board is the lead sponsor of 15 studies on the registry; 10 are open to participants now.
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Agreed to participate in the study.
Exclusion Criteria:
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
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
Intravenous insulin
to be given to both arms
to be given to all patients
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.
Time frame: At 2 hours from administration of medications
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).
(The investigators will categorize potassium levels into groups mild (5.5-6 mmol/l), moderate (6-6.5 mmol/l), and severe (\>6.5 mmol/l) and will see the mean difference in reduction in potassium level between the 2 doses).
Time frame: 2 hours from administration of medications
Association of mean potassium reduction with initial blood sugar level on potassium reduction
The investigators will categorize blood sugar into groups: Below 10mmol/L, 10.1-14.9 mmol/L, and 15 - 19.9mmol/L among each group the investigators will see the mean potassium reduction levels.
Time frame: 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
The investigators will investigate which group of patients will have a high risk of hypoglycemia ((e.g.: initial Glucose level, initial creatinin/renal function, comorbidities, type of dialysis….
Time frame: 2 hours from administration of medications
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Oct 2023 to primary completion in Sep 2025, 23 months.
Of 16 phase 4 interventional studies under Hyperkalemia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 44. This study's 23 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Albuterol
Oman Medical Speciality Board