xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06036823</url>
    </required_header>
    <id_info>
      <org_study_id>MREC #2779</org_study_id>
      <nct_id>NCT06036823</nct_id>
    </id_info>
    <brief_title>5 Versus 10 Units of Insulin in Hyperkalemia Management</brief_title>
    <official_title>5 Versus 10 Units of Insulin in Hyperkalemia Management: Multi-center, Prospective, Double-blind, Non-inferiority, Randomized Control Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Oman Medical Speciality Board</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Sultan Qaboos University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Oman Medical Speciality Board</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this study is to compare 5 units of intravenous Regular insulin to 10 units of&#xD;
        intravenous regular insulin in the management of hyperkalemia. We will measure the efficacy&#xD;
        of these 2 doses of insulin in reducing hyperkalemia at 2 hours from administration using the&#xD;
        main laboratory serum values.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Introduction: Hyperkalaemia is a serum Potassium (K) level of more than 5.5 mEq/L. It is a&#xD;
        common emergency medicine presentation and can be life-threatening. Because of the emergency&#xD;
        in correcting hyperkalemia, different medications are used to reduce high potassium levels to&#xD;
        normal as soon as possible. Salbutamol inhalers, Glucose solutions, and Insulin are the main&#xD;
        medications for managing hyperkalemia. Insulin and Dextrose shift potassium ions into body&#xD;
        cells by stimulating the sodium/potassium ATP pump. Its effect starts in less than fifteen&#xD;
        minutes and can last up to sixty minutes. It usually reduces potassium up to 1.1 mEq/l. There&#xD;
        are different recommendations for Insulin dose and rate of administration for patients with&#xD;
        hyperkalemia.&#xD;
  &#xD;
        Method: This will be a multi-center, prospective, double-blind, non-inferiority, randomized&#xD;
        control trial. 336 hyperkalemia patients will be randomized to the intervention group 5 units&#xD;
        of intravenous Regular insulin and 10 units of intravenous insulin groups with fifty ml of&#xD;
        Dextrose Fifty percent. They will be enrolled once their potassium level is 5.5mEq/L or more.&#xD;
        The attending physician and patient will be blinded about the dose of insulin that the&#xD;
        patient received. Serum potassium will be measured at 0 and at 120 minutes from the start of&#xD;
        the medications. Random blood glucose will be measured at 0, 60, and 120 minutes by&#xD;
        Glucometer. The safety of our patients will be assessed by documentation of all adverse&#xD;
        events, vital signs, and clinical assessment before and after drug administration. The study&#xD;
        will end at 2 hours from insulin administration.&#xD;
  &#xD;
        Aim: Our research idea aims to compare two recommended doses of Insulin (5 Units vs. 10 Units&#xD;
        of Regular insulin given intravenously over thirty minutes) in the management of patients&#xD;
        with hyperkalemia.&#xD;
  &#xD;
        Primary objective: Mean reduction in serum potassium level using the main laboratory results&#xD;
        at two hours from medication administration.&#xD;
  &#xD;
        Secondary objectives: effect of initial (baseline) potassium level on the mean potassium&#xD;
        reduction, and frequency of hypoglycemia between the 2 groups. Does the initial (baseline)&#xD;
        blood glucose level will affect the function of insulin/dextrose in lowering potassium&#xD;
        levels?&#xD;
  &#xD;
        Patient Population: Adult patients (Aged 18 years and older) who present to the Emergency&#xD;
        department at Sultan Qaboos University and Royal Hospital for evaluation and are found to&#xD;
        have potassium levels of 5.5 mEq/L and above.&#xD;
  &#xD;
        Intervention: Single dose of 5 units of intravenous insulin over 30 minutes with 50 ml of&#xD;
        Dextrose 50%.&#xD;
  &#xD;
        Clinical Measurement: Mean reduction of potassium level using the main laboratory results at&#xD;
        2 hours from insulin/dextrose administration. Hypoglycemia will be followed by a bedside&#xD;
        glucometer.&#xD;
  &#xD;
        Outcome: reduction of potassium level at 2 hours from medication administration and&#xD;
        medication safety.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Factorial Assignment</intervention_model>
      <intervention_model_description>the study group will receive 5 units of intravenous insulin control group will receive 10 unites of IV insulin</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
      <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.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>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).</measure>
      <time_frame>At 2 hours from administration of medications</time_frame>
      <description>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.&#xD;
  - The main laboratory result will be used to measure and follow the patients. results will be reported in mmol/L.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>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).</measure>
      <time_frame>2 hours from administration of medications</time_frame>
      <description>(The investigators will categorize potassium levels into groups mild (5.5-6 mmol/l), moderate (6-6.5 mmol/l), and severe (&gt;6.5 mmol/l) and will see the mean difference in reduction in potassium level between the 2 doses).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Association of mean potassium reduction with initial blood sugar level on potassium reduction</measure>
      <time_frame>2 hours from administration of medications</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>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</measure>
      <time_frame>2 hours from administration of medications</time_frame>
      <description>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….</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">336</enrollment>
    <condition>Hyperkalemia</condition>
    <condition>Potassium Imbalance</condition>
    <condition>Electrolyte Imbalance</condition>
    <condition>Electrolyte Disturbance</condition>
    <arm_group>
      <arm_group_label>5 units of intravenous R insulin</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Will receive:&#xD;
  IV Insulin Regular 5 units with Dextrose 50 % 50 ml over 30 minutes. Salbutamol 10 mg Nebulization over 15 minutes.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>10 units of intravenous R insulin</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Will Receive:&#xD;
  IV Insulin Regular 10 units with Dextrose 50 % 50 ml over 30 minutes. Salbutamol 10 mg nebulization over 15 minutes.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Insulin regular</intervention_name>
      <description>Intravenous insulin</description>
      <arm_group_label>10 units of intravenous R insulin</arm_group_label>
      <arm_group_label>5 units of intravenous R insulin</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dextrose 50</intervention_name>
      <description>to be given to both arms</description>
      <arm_group_label>10 units of intravenous R insulin</arm_group_label>
      <arm_group_label>5 units of intravenous R insulin</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>salbutamol</intervention_name>
      <description>to be given to all patients</description>
      <arm_group_label>10 units of intravenous R insulin</arm_group_label>
      <arm_group_label>5 units of intravenous R insulin</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Hyperkalemia patients with lab potassium levels equal to or more than 5.5 mEq/L (≥ 5.5&#xD;
               mEq/L)+.&#xD;
  &#xD;
            -  Adult: age 18 years or more.&#xD;
  &#xD;
            -  Agreed to participate in the study.&#xD;
  &#xD;
                 -  If an investigator decides to start anti-hyperkalemia medications based on the&#xD;
                    VBG/ABG patient can be enrolled but if the main laboratory value is less than 5.5&#xD;
                    mEq/L patients will be excluded&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Cardiac arrest&#xD;
  &#xD;
            -  Hyperglycemia with random blood sugar 20 mmol/L (13) or with acute diabetic&#xD;
               complications like Diabetic Ketoacidosis / Hyperosmolar Hyperglycemic State.&#xD;
  &#xD;
            -  Hypoglycemia with random blood sugar (RBS) ≤ 3.89 mmol/l in Diabetic patients and less&#xD;
               than 3 mmol/l in non-diabetic patients.&#xD;
  &#xD;
            -  Allergies for any medication in the protocol.&#xD;
  &#xD;
            -  Pregnancy.&#xD;
  &#xD;
            -  Hemolyzed potassium level as reported by the main lab.&#xD;
  &#xD;
            -  Hemolysis, Tumor lysis syndrome, or Rhabdomyolysis due to the ongoing release of&#xD;
               potassium.&#xD;
  &#xD;
            -  Acidosis with a pH less than 7.1 will require Sodium bicarbonate (NaHO3).&#xD;
  &#xD;
            -  A patient who will need urgent Furosemide (Lasix), and or dialysis during the study&#xD;
               period of 2 hours.&#xD;
  &#xD;
            -  Refused to participate.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Suad Al-Abri</last_name>
      <role>Principal Investigator</role>
      <affiliation>Sultan Qaboos University hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Adnan Al-Ajmi, MD</last_name>
      <phone>98880381</phone>
      <phone_ext>+968</phone_ext>
      <email>r2124@resident.omsb.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ibrahim Al-Hooti, MD</last_name>
      <phone>92985424</phone>
      <phone_ext>+968</phone_ext>
      <email>r2127@resident.omsb.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Sultan Qaboos University hospital</name>
        <address>
          <city>Seeb</city>
          <state>Muscat</state>
          <zip>123</zip>
          <country>Oman</country>
        </address>
      </facility>
      <contact>
        <last_name>Suad Al-Abri</last_name>
        <phone>99878005</phone>
        <phone_ext>+968</phone_ext>
        <email>ghammari@squ.edu.om</email>
      </contact>
      <contact_backup>
        <last_name>Saif Al-ghafri</last_name>
        <phone>99814471</phone>
        <phone_ext>+968</phone_ext>
        <email>saialghafri1@gmail.com</email>
      </contact_backup>
      <investigator>
        <last_name>Usama Al-Khallasi</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Ali Al-lawati</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>abdullah Al-Reesi</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Ibrahim Al - Hooti</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Abulmonem Al-Farsi</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Oman</country>
    </location_countries>
    <link>
      <url>https://www.uptodate.com/contents/causes-and-evaluation-of-hyperkalemia-in-adults</url>
      <description>David B Mount, MD. Causes and evaluation of hyperkalemia in adults</description>
    </link>
    <link>
      <url>https://www.uptodate.com/contents/treatment-and-prevention-of-hyperkalemia-in-adults?search=Treatment%20and%20prevention%20of%20hyperkalemia%20in%20adults&amp;source=search_result&amp;selectedTitle=1~150&amp;usage_type=default&amp;display_rank=1</url>
      <description>Treatment and prevention of hyperkalemia in adults</description>
    </link>
    <link>
      <url>https://emedicine.medscape.com/article/240903-treatment</url>
      <description>Hyperkalemia Treatment &amp; Management</description>
    </link>
    <link>
      <url>https://www.uptodate.com/contents/hypoglycemia-in-adults-without-diabetes-mellitus-clinical-manifestations-diagnosis-and-causes</url>
      <description>Hypoglycemia in adults without diabetes mellitus: Clinical manifestations, diagnosis, and causes</description>
    </link>
    <link>
      <url>https://www.acep.org/patient-care/hyperk/</url>
      <description>Hyper K recognition and treatment of Hyperkalemia in the ED. American College of Emergency Physicians.</description>
    </link>
    <reference>
      <citation>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.</citation>
      <PMID>34167889</PMID>
    </reference>
    <reference>
      <citation>Ron M. Walls, MD. Hyperkalemia. Rosen emergency medince Concepts and Clinical practice. 9th. Philadelphia : Elsevier, 2018, 117, pp. 1516 - 1519.</citation>
    </reference>
    <reference>
      <citation>Judith E. Tintinalli, MD, MS. Hyperkalemia. Tintinalli's Emergency Medicine a comprehensive study guide. 9th. s.l. : McGraw-Hill Education, 2020, 17, p. 89.</citation>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>29725636</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>32426734</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>28976587</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>33993515</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>27148740</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>30189765</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Oman Medical Speciality Board</investigator_affiliation>
      <investigator_full_name>Adnan Al-Ajmi</investigator_full_name>
      <investigator_title>Doctor</investigator_title>
    </responsible_party>
    <keyword>insulin</keyword>
    <keyword>hyperkalemia</keyword>
    <keyword>hypoglycmiea</keyword>
    <keyword>anti-hyperkalemia</keyword>
    <keyword>electrolytes abnormalities</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hyperkalemia</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Insulin</mesh_term>
      <mesh_term>Insulin, Globin Zinc</mesh_term>
      <mesh_term>Albuterol</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Informed Consent Form</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>August 10, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/23/NCT06036823/Prot_ICF_000.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Statistical Analysis Plan</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>August 3, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/23/NCT06036823/SAP_001.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06036823
  org study id: MREC #2779
  nct id: NCT06036823
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  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 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.
  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 insulin
  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.
  measure: 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
  description: 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.
  measure: 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).
  time frame: 2 hours from administration of medications
  description: (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).
  measure: Association of mean potassium reduction with initial blood sugar level on potassium reduction
  time frame: 2 hours from administration of medications
  description: 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.
  measure: 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
  time frame: 2 hours from administration of medications
  description: 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….
  arm group label: 5 units of intravenous R insulin
  arm group type: Active Comparator
  description: Will receive:
  IV Insulin Regular 5 units with Dextrose 50 % 50 ml over 30 minutes. Salbutamol 10 mg Nebulization over 15 minutes.
  arm group label: 10 units of intravenous R insulin
  arm group type: Active Comparator
  description: Will Receive:
  IV Insulin Regular 10 units with Dextrose 50 % 50 ml over 30 minutes. Salbutamol 10 mg nebulization over 15 minutes.
  intervention type: Drug
  intervention name: Insulin regular
  description: Intravenous insulin
  arm group label: 10 units of intravenous R insulin
  arm group label: 5 units of intravenous R insulin
  intervention type: Drug
  intervention name: Dextrose 50
  description: to be given to both arms
  arm group label: 10 units of intravenous R insulin
  arm group label: 5 units of intravenous R insulin
  intervention type: Drug
  intervention name: salbutamol
  description: to be given to all patients
  arm group label: 10 units of intravenous R insulin
  arm group label: 5 units of intravenous R insulin
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Suad Al-Abri
  role: Principal Investigator
  affiliation: Sultan Qaboos University hospital
  last name: Adnan Al-Ajmi, MD
  phone: 98880381
  phone ext: +968
  email: r2124@resident.omsb.org
  last name: Ibrahim Al-Hooti, MD
  phone: 92985424
  phone ext: +968
  email: r2127@resident.omsb.org
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Oman
  url: https://www.uptodate.com/contents/causes-and-evaluation-of-hyperkalemia-in-adults
  description: David B Mount, MD. Causes and evaluation of hyperkalemia in adults
  url: https://www.uptodate.com/contents/treatment-and-prevention-of-hyperkalemia-in-adults?search=Treatment%20and%20prevention%20of%20hyperkalemia%20in%20adults&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1
  description: Treatment and prevention of hyperkalemia in adults
  url: https://emedicine.medscape.com/article/240903-treatment
  description: Hyperkalemia Treatment & Management
  url: https://www.uptodate.com/contents/hypoglycemia-in-adults-without-diabetes-mellitus-clinical-manifestations-diagnosis-and-causes
  description: Hypoglycemia in adults without diabetes mellitus: Clinical manifestations, diagnosis, and causes
  url: https://www.acep.org/patient-care/hyperk/
  description: Hyper K recognition and treatment of Hyperkalemia in the ED. American College of Emergency Physicians.
  citation: 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
  citation: Ron M. Walls, MD. Hyperkalemia. Rosen emergency medince Concepts and Clinical practice. 9th. Philadelphia : Elsevier, 2018, 117, pp. 1516 - 1519.
  citation: Judith E. Tintinalli, MD, MS. Hyperkalemia. Tintinalli's Emergency Medicine a comprehensive study guide. 9th. s.l. : McGraw-Hill Education, 2020, 17, p. 89.
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  responsible party type: Principal Investigator
  investigator affiliation: Oman Medical Speciality Board
  investigator full name: Adnan Al-Ajmi
  investigator title: Doctor
  mesh term: Hyperkalemia
  mesh term: Insulin
  mesh term: Insulin, Globin Zinc
  mesh term: Albuterol
  sharing ipd: Undecided
  provided document: 
  provided document: 