<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/NCT04491357</url>
  </required_header>
  <id_info>
    <org_study_id>2020225-8316</org_study_id>
    <nct_id>NCT04491357</nct_id>
  </id_info>
  <brief_title>Prophylactic Infusion of Calcium Gluconate Reducing the Rate of Hypocalcaemia After Total Thyroidectomy</brief_title>
  <official_title>The Use of Prophylactic Infusion of Calcium Gluconate Compared to Placebo in Reducing the Rate of Hypocalcaemia After Total Thyroidectomy: A Double-Blinded, Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Malaya</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Malaya</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Post-total thyroidectomy hypocalcaemia is a common complication with the rate ranging from&#xD;
      13-49% in a meta-analysis. However, the rate in UMMC in 2018 and 2019 were 40% and 23%&#xD;
      respectively. It lead to prolonged hospital stay and patient dissatisfaction in the event of&#xD;
      hypocalcaemia.&#xD;
&#xD;
      Research question: Does prophylactic intravenous calcium infusion reduces the rate of&#xD;
      post-total thyroidectomy hypocalcaemia? This study will conduct in UMMC endocrine surgery&#xD;
      unit with the target population who scheduled for total thyroidectomy in UMMC between&#xD;
      1/6/2020-1/6/2022.&#xD;
&#xD;
      After obtaining consent from participants, they will be randomised into intervention and&#xD;
      placebo group with the ratio of 1:1. Intervention group will receive the intravenous calcium&#xD;
      gluconate infusion and placebo group will receive saline infusion within 4 hour of skin&#xD;
      closure. Both groups will have their serum calcium measure at 6,12,24,36,48-hour mark post&#xD;
      surgery. Both groups will receive same oral calcium supplements.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All participating patients will be randomised into intervention and placebo arm with 1:1&#xD;
      ratio. Intervention group will receive 1 ampoule of intravenous calcium gluconate within 4&#xD;
      hours of post total thyroidectomy, whereas the placebo group will received 100ml of normal&#xD;
      saline only. Both groups will receive same oral calcium supplements post surgery. Both groups&#xD;
      will have their serum calcium measure at 6,12,24,36,48-hour mark post surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2022</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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of hypocalcaemia after total thyroidectomy</measure>
    <time_frame>first 48 hours after total thyroidectomy</time_frame>
    <description>To determine whether prophylactic infusion of calcium gluconate reduces the rate of hypocalcaemia after total thyroidectomy compared to placebo treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>first 48 hours after total thyroidectomy</time_frame>
    <description>To determine whether prophylactic infusion of calcium gluconate reduces the length of hospital stay compared to placebo group</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Hypocalcemia</condition>
  <arm_group>
    <arm_group_label>Intervention arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention arm will receive 1 ampoule of intravenous calcium gluconate within 4 hours of skin closure post total thyroidectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo arm will receive 100ml of normal saline within 4 hours of skin closure post total thyroidectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Calcium Gluconate</intervention_name>
    <description>Intravenous calcium gluconate within 4 hours of skin closure after total thyroidectomy</description>
    <arm_group_label>Intervention arm</arm_group_label>
    <other_name>Intravenous calcium gluconate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>Normal saline within 4 hours of skin closure after total thyroidectomy</description>
    <arm_group_label>Placebo arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18-80 years old&#xD;
&#xD;
          -  Scheduled for total thyroidectomy in UMMC&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Their age outside the range of 18-80&#xD;
&#xD;
          -  Have parathyroid disorders or end stage renal failure&#xD;
&#xD;
          -  On calcium or vitamin D supplements prior to surgery&#xD;
&#xD;
          -  Have deranged calcium homeostasis (outside the normal range of 2.2-2.6 mmol/L)&#xD;
&#xD;
          -  Scheduled for total thyroidectomy plus lymph node dissection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kah Seng Khoo</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Malaya</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kah Seng Khoo</last_name>
    <phone>+60172489272</phone>
    <email>kahseng901209@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Malaya Medical Centre</name>
      <address>
        <city>Kuala Lumpur</city>
        <zip>59100</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kah Seng Khoo</last_name>
      <phone>+60172489272</phone>
      <email>kahseng901209@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Department of Surgery University of Malaya</last_name>
      <phone>03-7967 6695</phone>
      <email>fomadmin@um.edu.my</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Malaya</investigator_affiliation>
    <investigator_full_name>Khoo Kah Seng</investigator_full_name>
    <investigator_title>Surgical Resident, Department of Surgery, Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Hypocalcaemia</keyword>
  <keyword>Total thyroidectomy</keyword>
  <keyword>Calcium gluconate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypocalcemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium, Dietary</mesh_term>
    <mesh_term>Calcium</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Not to share IPD to other researchers</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04491357
org study id: 2020225-8316
nct id: NCT04491357
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Post-total thyroidectomy hypocalcaemia is a common complication with the rate ranging from
      13-49% in a meta-analysis. However, the rate in UMMC in 2018 and 2019 were 40% and 23%
      respectively. It lead to prolonged hospital stay and patient dissatisfaction in the event of
      hypocalcaemia.

      Research question: Does prophylactic intravenous calcium infusion reduces the rate of
      post-total thyroidectomy hypocalcaemia? This study will conduct in UMMC endocrine surgery
      unit with the target population who scheduled for total thyroidectomy in UMMC between
      1/6/2020-1/6/2022.

      After obtaining consent from participants, they will be randomised into intervention and
      placebo group with the ratio of 1:1. Intervention group will receive the intravenous calcium
      gluconate infusion and placebo group will receive saline infusion within 4 hour of skin
      closure. Both groups will have their serum calcium measure at 6,12,24,36,48-hour mark post
      surgery. Both groups will receive same oral calcium supplements.
All participating patients will be randomised into intervention and placebo arm with 1:1
      ratio. Intervention group will receive 1 ampoule of intravenous calcium gluconate within 4
      hours of post total thyroidectomy, whereas the placebo group will received 100ml of normal
      saline only. Both groups will receive same oral calcium supplements post surgery. Both groups
      will have their serum calcium measure at 6,12,24,36,48-hour mark post surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Rate of hypocalcaemia after total thyroidectomy
time frame: first 48 hours after total thyroidectomy
description: To determine whether prophylactic infusion of calcium gluconate reduces the rate of hypocalcaemia after total thyroidectomy compared to placebo treatment
measure: Length of hospital stay
time frame: first 48 hours after total thyroidectomy
description: To determine whether prophylactic infusion of calcium gluconate reduces the length of hospital stay compared to placebo group
arm group label: Intervention arm
arm group type: Experimental
description: Intervention arm will receive 1 ampoule of intravenous calcium gluconate within 4 hours of skin closure post total thyroidectomy
arm group label: Placebo arm
arm group type: Placebo Comparator
description: Placebo arm will receive 100ml of normal saline within 4 hours of skin closure post total thyroidectomy
intervention type: Drug
intervention name: Calcium Gluconate
description: Intravenous calcium gluconate within 4 hours of skin closure after total thyroidectomy
arm group label: Intervention arm
other name: Intravenous calcium gluconate
intervention type: Drug
intervention name: Normal saline
description: Normal saline within 4 hours of skin closure after total thyroidectomy
arm group label: Placebo arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kah Seng Khoo
role: Principal Investigator
affiliation: University of Malaya
last name: Kah Seng Khoo
phone: +60172489272
email: kahseng901209@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Malaysia
responsible party type: Principal Investigator
investigator affiliation: University of Malaya
investigator full name: Khoo Kah Seng
investigator title: Surgical Resident, Department of Surgery, Principal Investigator
mesh term: Hypocalcemia
mesh term: Calcium, Dietary
mesh term: Calcium
sharing ipd: No
ipd description: Not to share IPD to other researchers