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

NCT04491357 | Unknown Phase 4

• 1 other identifier: 2020225-8316
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypocalcemia

Keywords

Hypocalcaemia; Total thyroidectomy; Calcium gluconate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Length of hospital stay

  first 48 hours after total thyroidectomy

Study Arms (2)

Intervention arm

EXPERIMENTAL

Intervention arm will receive 1 ampoule of intravenous calcium gluconate within 4 hours of skin closure post total thyroidectomy

Drug: Calcium Gluconate

Placebo arm

PLACEBO COMPARATOR

Placebo arm will receive 100ml of normal saline within 4 hours of skin closure post total thyroidectomy

Drug: Normal saline

Interventions

Calcium Gluconate DRUG

Intravenous calcium gluconate within 4 hours of skin closure after total thyroidectomy

Also known as: Intravenous calcium gluconate

Intervention arm

Normal saline DRUG

Normal saline within 4 hours of skin closure after total thyroidectomy

Placebo arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18-80 years old
• Scheduled for total thyroidectomy in UMMC

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

RECRUITING

Related Publications (1)

• Khoo KS, Yeo A, Mirzan Asfian MRB, Ng KL. The use of prophylactic infusion of calcium gluconate compared to placebo in reducing the rate of early hypocalcaemia after total thyroidectomy: a double-blinded, randomized controlled trial. Gland Surg. 2024 Aug 31;13(8):1378-1386. doi: 10.21037/gs-24-190. Epub 2024 Aug 28.

  PMID: 39282041 DERIVED

MeSH Terms

Conditions

Hypocalcemia

Interventions

Calcium Gluconate; Saline Solution

Condition Hierarchy (Ancestors)

Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance

Intervention Hierarchy (Ancestors)

Gluconates; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Kah Seng Khoo

  University of Malaya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kah Seng Khoo

CONTACT

+60172489272; kahseng901209@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgical Resident, Department of Surgery, Principal Investigator

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: July 29, 2020
• Study Start: June 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: July 31, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)