Prophylactic Infusion of Calcium Gluconate Reducing the Rate of Hypocalcaemia After Total Thyroidectomy

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

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.

Study Overview

• Status: Unknown
• Conditions: Hypocalcemia
• Intervention / Treatment: Drug: Calcium Gluconate; Drug: Normal saline

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kah Seng Khoo; Phone Number: +60172489272; Email: kahseng901209@gmail.com

Study Locations

• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • Recruiting
    • University Malaya Medical Centre
    • Contact: Kah Seng Khoo; Phone Number: +60172489272; Email: kahseng901209@gmail.com
    • Contact: Department of Surgery University of Malaya; Phone Number: 03-7967 6695; Email: fomadmin@um.edu.my

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention arm; Intervention arm will receive 1 ampoule of intravenous calcium gluconate within 4 hours of skin closure post total thyroidectomy	Drug: Calcium Gluconate; Intravenous calcium gluconate within 4 hours of skin closure after total thyroidectomy; Other Names: Intravenous calcium gluconate
PLACEBO_COMPARATOR: Placebo arm; Placebo arm will receive 100ml of normal saline within 4 hours of skin closure post total thyroidectomy	Drug: Normal saline; Normal saline within 4 hours of skin closure after total thyroidectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	first 48 hours after total thyroidectomy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	To determine whether prophylactic infusion of calcium gluconate reduces the length of hospital stay compared to placebo group	first 48 hours after total thyroidectomy

Collaborators and Investigators

• Sponsor: University of Malaya
• Investigators: Principal Investigator: Kah Seng Khoo, University of Malaya

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2020
• Primary Completion (ANTICIPATED): June 1, 2022
• Study Completion (ANTICIPATED): June 1, 2022

Study Registration Dates

• First Submitted: July 24, 2020
• First Submitted That Met QC Criteria: July 24, 2020
• First Posted (ACTUAL): July 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 31, 2020
• Last Update Submitted That Met QC Criteria: July 29, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Total thyroidectomy; Calcium gluconate; Hypocalcaemia
• Additional Relevant MeSH Terms: Metabolic Diseases; Calcium Metabolism Disorders; Water-Electrolyte Imbalance; Hypocalcemia; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Calcium; Calcium, Dietary
• Other Study ID Numbers: 2020225-8316

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not to share IPD to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No