5 Versus 10 Units of Insulin in Hyperkalemia Management: Multi-center, Prospective, Double-blind, Non-inferiority, Randomized Control Trial.
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Oman Medical Speciality Board
- Enrollment
- 384
- Locations
- 1
- Primary Endpoint
- 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).
Overview
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Insulin regular (Drug)
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.
Intervention: Dextrose 50 (Drug)
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.
Intervention: salbutamol (Drug)
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.
Intervention: Insulin regular (Drug)
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.
Intervention: Dextrose 50 (Drug)
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.
Intervention: salbutamol (Drug)
Outcomes
Primary Outcomes
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).
Time Frame: At 2 hours from administration of medications
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.
Secondary Outcomes
- 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)
Investigators
Adnan Al-Ajmi
Doctor
Oman Medical Speciality Board