5 Versus 10 Units of Insulin in Hyperkalemia Management

Sponsor

Oman Medical Speciality Board (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06036823

Collaborator

Sultan Qaboos University (Other)

336

Enrollment

Location

Arms

Anticipated Duration (Months)

22.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperkalemia Potassium Imbalance Electrolyte Imbalance Electrolyte Disturbance	Drug: Insulin regular Drug: Dextrose 50 Drug: salbutamol	Phase 4

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 and Royal 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

Anticipated Enrollment :

336 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

the study group will receive 5 units of intravenous insulin control group will receive 10 unites of IV insulinthe study group will receive 5 units of intravenous insulin control group will receive 10 unites of IV insulin

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.

Primary Purpose:

Treatment

Official Title:

5 Versus 10 Units of Insulin in Hyperkalemia Management: Multi-center, Prospective, Double-blind, Non-inferiority, Randomized Control Trial.

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Insulin regular Intravenous insulin Drug: Dextrose 50 to be given to both arms Drug: salbutamol to be given to all patients
Active Comparator: 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.	Drug: Insulin regular Intravenous insulin Drug: Dextrose 50 to be given to both arms Drug: salbutamol to be given to all patients

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: Insulin regular

Intravenous insulin

Drug: Dextrose 50

to be given to both arms

Drug: salbutamol

to be given to all patients

Active Comparator: 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.

Drug: Insulin regular

Intravenous insulin

Drug: Dextrose 50

to be given to both arms

Drug: salbutamol

to be given to all patients

Outcome Measures

Primary Outcome Measures

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). [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 Outcome Measures

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]
(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).
Association of mean potassium reduction with initial blood sugar level on potassium reduction [2 hours from administration of medications]
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.
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]
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….

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.