Prophylactic Infusion of Calcium Gluconate Reducing the Rate of Hypocalcaemia After Total Thyroidectomy
Primary Purpose
Hypocalcemia
Status
Unknown status
Phase
Phase 4
Locations
Malaysia
Study Type
Interventional
Intervention
Calcium Gluconate
Normal saline
Sponsored by
About this trial
This is an interventional prevention trial for Hypocalcemia focused on measuring Hypocalcaemia, Total thyroidectomy, Calcium gluconate
Eligibility Criteria
Inclusion Criteria:
- Age between 18-80 years old
- Scheduled for total thyroidectomy in UMMC
Exclusion Criteria:
- Their age outside the range of 18-80
- Have parathyroid disorders or end stage renal failure
- On calcium or vitamin D supplements prior to surgery
- Have deranged calcium homeostasis (outside the normal range of 2.2-2.6 mmol/L)
- Scheduled for total thyroidectomy plus lymph node dissection
Sites / Locations
- University Malaya Medical CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention arm
Placebo arm
Arm Description
Intervention arm will receive 1 ampoule of intravenous calcium gluconate within 4 hours of skin closure post total thyroidectomy
Placebo arm will receive 100ml of normal saline within 4 hours of skin closure post total thyroidectomy
Outcomes
Primary Outcome Measures
Rate of hypocalcaemia after total thyroidectomy
To determine whether prophylactic infusion of calcium gluconate reduces the rate of hypocalcaemia after total thyroidectomy compared to placebo treatment
Secondary Outcome Measures
Length of hospital stay
To determine whether prophylactic infusion of calcium gluconate reduces the length of hospital stay compared to placebo group
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04491357
Brief Title
Prophylactic Infusion of Calcium Gluconate Reducing the Rate of Hypocalcaemia After Total Thyroidectomy
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaya
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypocalcemia
Keywords
Hypocalcaemia, Total thyroidectomy, Calcium gluconate
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Intervention arm will receive 1 ampoule of intravenous calcium gluconate within 4 hours of skin closure post total thyroidectomy
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
Placebo arm will receive 100ml of normal saline within 4 hours of skin closure post total thyroidectomy
Intervention Type
Drug
Intervention Name(s)
Calcium Gluconate
Other Intervention Name(s)
Intravenous calcium gluconate
Intervention Description
Intravenous calcium gluconate within 4 hours of skin closure after total thyroidectomy
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Normal saline within 4 hours of skin closure after total thyroidectomy
Primary Outcome Measure Information:
Title
Rate of hypocalcaemia after total thyroidectomy
Description
To determine whether prophylactic infusion of calcium gluconate reduces the rate of hypocalcaemia after total thyroidectomy compared to placebo treatment
Time Frame
first 48 hours after total thyroidectomy
Secondary Outcome Measure Information:
Title
Length of hospital stay
Description
To determine whether prophylactic infusion of calcium gluconate reduces the length of hospital stay compared to placebo group
Time Frame
first 48 hours after total thyroidectomy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age between 18-80 years old
Scheduled for total thyroidectomy in UMMC
Exclusion Criteria:
Their age outside the range of 18-80
Have parathyroid disorders or end stage renal failure
On calcium or vitamin D supplements prior to surgery
Have deranged calcium homeostasis (outside the normal range of 2.2-2.6 mmol/L)
Scheduled for total thyroidectomy plus lymph node dissection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kah Seng Khoo
Phone
+60172489272
Email
kahseng901209@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kah Seng Khoo
Organizational Affiliation
University of Malaya
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kah Seng Khoo
Phone
+60172489272
Email
kahseng901209@gmail.com
First Name & Middle Initial & Last Name & Degree
Department of Surgery University of Malaya
Phone
03-7967 6695
Email
fomadmin@um.edu.my
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Not to share IPD to other researchers
Learn more about this trial
Prophylactic Infusion of Calcium Gluconate Reducing the Rate of Hypocalcaemia After Total Thyroidectomy
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