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

Hypocalcemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04491357
• Other study ID #: 2020225-8316
• Status: Recruiting
• Phase: Phase 4
• Start date: June 1, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: July 2020
• Source: University of Malaya
• Contact: Kah Seng Khoo
• Phone: +60172489272
• Email: kahseng901209[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypocalcemia

Intervention

Drug:
• Calcium Gluconate
Intravenous calcium gluconate within 4 hours of skin closure after total thyroidectomy
• Normal saline
Normal saline within 4 hours of skin closure after total thyroidectomy

Locations

Country	Name	City	State
Malaysia	University Malaya Medical Centre	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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