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Electrolyte Supplement

Intervention arm for Hypocalcemia

Phase 4
Waitlist Available
Led By Kah Seng Khoo
Research Sponsored by University of Malaya
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first 48 hours after total thyroidectomy
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Drug Has Already Been Approved
Pivotal 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.

Eligible Conditions
  • Hypocalcemia
  • Low Calcium

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first 48 hours after total thyroidectomy
This trial's timeline: 3 weeks for screening, Varies for treatment, and first 48 hours after total thyroidectomy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of hypocalcaemia after total thyroidectomy
Secondary study objectives
Length of hospital stay

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intervention armExperimental Treatment1 Intervention
Intervention arm will receive 1 ampoule of intravenous calcium gluconate within 4 hours of skin closure post total thyroidectomy
Group II: Placebo armPlacebo Group1 Intervention
Placebo arm will receive 100ml of normal saline within 4 hours of skin closure post total thyroidectomy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Calcium gluconate
FDA approved

Find a Location

Who is running the clinical trial?

University of MalayaLead Sponsor
289 Previous Clinical Trials
81,180 Total Patients Enrolled
Kah Seng KhooPrincipal InvestigatorUniversity of Malaya
~9 spots leftby Dec 2025
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