HypocalcemiaPhase 4NCT04491357
Prophylactic Infusion of Calcium Gluconate Reducing the Rate of Hypocalcaemia After Total Thyroidectomy
A Phase 4 study testing Calcium Gluconate and Normal saline in people with Hypocalcemia, run by University of Malaya at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypocalcemia
- What is being tested?
- Calcium Gluconate and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jun 2020to 1 Jun 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18-80 years old
- Scheduled for total thyroidectomy in UMMC
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
University Malaya Medical Centre
Kuala Lumpur, 59100
Kah Seng Khoo, +60172489272, kahseng901209@gmail.com
Department of Surgery University of Malaya, 03-7967 6695, fomadmin@um.edu.my
About this study
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
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.
Read the 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.
- Conditions
- Hypocalcemia
- Being tested
- Calcium Gluconate, Normal saline
- Keywords
- Hypocalcaemia, Total thyroidectomy, Calcium gluconate
- Medical subject headings
- Hypocalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium GluconateDrug
Also called Intravenous calcium gluconate
Intravenous calcium gluconate within 4 hours of skin closure after total thyroidectomy
Normal salineDrug
Normal saline within 4 hours of skin closure after total thyroidectomy
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Intervention arm will receive 1 ampoule of intravenous calcium gluconate within 4 hours of skin closure post total thyroidectomy Receives: Drug: Calcium Gluconate |
| Placebo arm | Placebo comparator | Placebo arm will receive 100ml of normal saline within 4 hours of skin closure post total thyroidectomy Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: first 48 hours after total thyroidectomy
Secondary outcomes (1)
Length of hospital stay
To determine whether prophylactic infusion of calcium gluconate reduces the length of hospital stay compared to placebo group
Measured: first 48 hours after total thyroidectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start1 Jun 2020
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypocalcemiaStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khoo Kah Seng, University of Malaya
- Investigators
- Kah Seng Khoo, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491357
- Sponsor's protocol ID
- 2020225-8316
- Status last verified
- Jul 2020
- First submitted
- 24 Jul 2020
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not to share IPD to other researchers
Publications
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.
PubMed 39282041
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04491357
- Acronym / sponsor ID
- 2020225-8316
- Conditions
- Hypocalcemia
- Keywords
- Hypocalcaemia, Total thyroidectomy, Calcium gluconate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 29 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Drug: Calcium GluconateIntervention arm will receive 1 ampoule of intravenous calcium gluconate within 4 hours of skin closure post total thyroidectomy |
| Placebo arm | Placebo comparator | Drug: Normal salinePlacebo arm will receive 100ml of normal saline within 4 hours of skin closure post total thyroidectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 18-80 years old
- Scheduled for total thyroidectomy in UMMC
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium GluconateAlso: Intravenous calcium gluconateIntravenous calcium gluconate within 4 hours of skin closure after total thyroidectomy | Drug | Intervention arm |
| Normal salineNormal saline within 4 hours of skin closure after total thyroidectomy | Drug | Placebo arm |
Primary outcome
Rate of hypocalcaemia after total thyroidectomy
Time frame: 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
1 secondary outcome
Length of hospital stay
Time frame: first 48 hours after total thyroidectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
- Derived from this study: PubMed 39282041Khoo 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.
- Individual participant dataSharing planned: No. Not to share IPD to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kah Seng Khoo principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Calcium Gluconate and Normal saline in people with Hypocalcemia, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kah Seng Khoo (+60172489272, kahseng901209@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of hypocalcaemia after total thyroidectomy (time frame: first 48 hours after total thyroidectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04491357, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2020.