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

Sponsor

University of Malaya (Other)

Overall Status

Unknown status

CT.gov ID

NCT04491357

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypocalcemia	Drug: Calcium Gluconate Drug: Normal saline	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Jun 1, 2020

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Rate of hypocalcaemia after total thyroidectomy [first 48 hours 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 [first 48 hours after total thyroidectomy]
To determine whether prophylactic infusion of calcium gluconate reduces the length of hospital stay compared to placebo group

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Malaya Medical Centre	Kuala Lumpur		Malaysia	59100

Sponsors and Collaborators

University of Malaya

Investigators

Principal Investigator: Kah Seng Khoo, University of Malaya

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Khoo Kah Seng, Surgical Resident, Department of Surgery, Principal Investigator, University of Malaya

ClinicalTrials.gov Identifier:

NCT04491357

Other Study ID Numbers:

2020225-8316

First Posted:

Jul 29, 2020

Last Update Posted:

Jul 31, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Khoo Kah Seng, Surgical Resident, Department of Surgery, Principal Investigator, University of Malaya

Hypocalcaemia

Total thyroidectomy

Calcium gluconate

Additional relevant MeSH terms:

Hypocalcemia

Calcium, Dietary

Calcium

Study Results

No Results Posted as of Jul 31, 2020