Postoperative HypocalcemiaNCT07701824
Ionized Calcium Changes for Predicting Postoperative Hypocalcemia After Total Thyroidectomy
An observational study of Postoperative Hypocalcemia and Postoperative Hypoparathyroidism, run by Emrecan Deniz at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to evaluate whether changes in ionized calcium levels measured by blood gas analysis during the preoperative, intraoperative, and postoperative periods can predict postoperative hypocalcemia in patients undergoing total thyroidectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Hypocalcemia, Postoperative Hypoparathyroidism, Total Thyroidectomy
- What is being tested?
- Calcium
- How many people
- 327 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jun 2025to 5 Jul 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 75 years
- All sexes
- Adult, Older adult
Study population: Patients admitted to Başakşehir Çam and Sakura City Hospital who are scheduled to undergo total thyroidectomy.
Who may be able to join
- Patients aged 18 to 75 years
- Present to the General Surgery Clinic of Başakşehir Çam and Sakura City Hospital
- Diagnosis of thyroid disorders according to ICD code E07
- Scheduled to undergo total thyroidectomy due to toxic multinodular goiter, multinodular goiter, or papillary carcinoma
- Provide informed consent to participate in the study.
Who cannot join
- Patients with preoperative parathyroid disorders associated hypocalcemia or hypercalcemia.
- Patients with a history of previous thyroidectomy
- Patients with a history of previous parathyroidectomy
- Patients with a history of previous neck surgery.
- Patients with chronic kidney disease.
- Patients with a history of non-thyroid malignancy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Basaksehir Cam and Sakura City Hospital
Başakşehir
About this study
Official title: Predictive Value of Preoperative, Intraoperative, and Postoperative Ionized Calcium Changes Measured by Blood Gas Analysis for Postoperative Hypocalcemia After Total Thyroidectomy
This prospective observational study aims to evaluate whether changes in ionized calcium levels measured by blood gas analysis during the preoperative, intraoperative, and postoperative periods can predict postoperative hypocalcemia in patients undergoing total thyroidectomy. Ionized calcium values obtained at predefined perioperative time points will be compared with postoperative biochemical and clinical hypocalcemia outcomes.
Read the detailed description
Postoperative hypocalcemia is a common complication after total thyroidectomy and may be associated with changes in calcium homeostasis and parathyroid function. Early identification of patients at risk for postoperative hypocalcemia may help guide postoperative monitoring and calcium replacement strategies.
This prospective observational study included patients who underwent total thyroidectomy. Ionized calcium levels were measured by blood gas analysis at predefined perioperative time points, including the preoperative, intraoperative, and postoperative periods. Serum parathyroid hormone levels were also recorded. The study evaluated the relationship between perioperative changes in ionized calcium levels, postoperative parathyroid hormone changes, and the development of postoperative hypocalcemia.
The primary objective was to determine whether perioperative ionized calcium changes can predict postoperative hypocalcemia after total thyroidectomy. Secondary objectives included evaluating the association between postoperative parathyroid hormone changes and postoperative hypocalcemia and assessing the diagnostic performance of ionized calcium measurements for predicting hypocalcemia.
- Being tested
- Calcium
- Keywords
- ionized calcium, blood gas analysis, total thyroidectomy, postoperative hypocalcemia, postoperative hypoparathyroidism, calcium monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalciumDiagnostic test
Ionized calcium levels will be measured by blood gas analysis at predefined preoperative, intraoperative, and postoperative time points in patients undergoing total thyroidectomy.
| Study group | Role | What they receive |
|---|---|---|
| total thyroidectomy patients | Not described Receives: Diagnostic Test: Calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
ionized calcium
Ionized calcium levels will be measured by blood gas analysis at predefined preoperative and postoperative time points in patients undergoing total thyroidectomy.
Measured: Preoperative baseline; postoperative 10 minutes; postoperative 6 hours
parathormone levels
Serum parathyroid hormone levels will be measured in patients undergoing total thyroidectomy to evaluate the association between postoperative parathyroid hormone changes and postoperative hypocalcemia.
Measured: Preoperative baseline; postoperative 10 minutes; postoperative 6 hours; and postoperative 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start12 Jun 2025
- Primary completion25 Apr 2026
- Study completion5 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative HypocalcemiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 327 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Emrecan Deniz
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Emrecan Deniz, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701824
- Sponsor's protocol ID
- KAEK-11/12.03.2025.87
- Status last verified
- Jul 2025
- First submitted
- 26 Jun 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Preoperative, Intraoperative, and Postoperative Ionized Calcium Changes Measured by Blood Gas Analysis for Postoperative Hypocalcemia After Total Thyroidectomy
- ClinicalTrials.gov ID
- NCT07701824
- Acronym / sponsor ID
- KAEK-11/12.03.2025.87
- Keywords
- ionized calcium, blood gas analysis, total thyroidectomy, postoperative hypocalcemia, postoperative hypoparathyroidism, calcium monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- Emrecan DenizOther government
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- 25 Apr 2026 (actual)
- Study completion
- 5 Jul 2026 (actual)
- First posted
- 14 Jul 2026 (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.
This prospective observational study aims to evaluate whether changes in ionized calcium levels measured by blood gas analysis during the preoperative, intraoperative, and postoperative periods can predict postoperative hypocalcemia in patients undergoing total thyroidectomy. Ionized calcium values obtained at predefined perioperative time points will be compared with postoperative biochemical and clinical hypocalcemia outcomes.
Detailed description
Postoperative hypocalcemia is a common complication after total thyroidectomy and may be associated with changes in calcium homeostasis and parathyroid function. Early identification of patients at risk for postoperative hypocalcemia may help guide postoperative monitoring and calcium replacement strategies.
This prospective observational study included patients who underwent total thyroidectomy. Ionized calcium levels were measured by blood gas analysis at predefined perioperative time points, including the preoperative, intraoperative, and postoperative periods. Serum parathyroid hormone levels were also recorded. The study evaluated the relationship between perioperative changes in ionized calcium levels, postoperative parathyroid hormone changes, and the development of postoperative hypocalcemia.
The primary objective was to determine whether perioperative ionized calcium changes can predict postoperative hypocalcemia after total thyroidectomy. Secondary objectives included evaluating the association between postoperative parathyroid hormone changes and postoperative hypocalcemia and assessing the diagnostic performance of ionized calcium measurements for predicting hypocalcemia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| total thyroidectomy patients | – | Diagnostic Test: Calcium |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to Başakşehir Çam and Sakura City Hospital who are scheduled to undergo total thyroidectomy.
Key inclusion criteria (5 listed)
- Patients aged 18 to 75 years
- Present to the General Surgery Clinic of Başakşehir Çam and Sakura City Hospital
- Diagnosis of thyroid disorders according to ICD code E07
- Scheduled to undergo total thyroidectomy due to toxic multinodular goiter, multinodular goiter, or papillary carcinoma
- Provide informed consent to participate in the study.
Key exclusion criteria (6 listed)
- Patients with preoperative parathyroid disorders associated hypocalcemia or hypercalcemia.
- Patients with a history of previous thyroidectomy
- Patients with a history of previous parathyroidectomy
- Patients with a history of previous neck surgery.
- Patients with chronic kidney disease.
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 |
|---|---|---|
| CalciumIonized calcium levels will be measured by blood gas analysis at predefined preoperative, intraoperative, and postoperative time points in patients undergoing total thyroidectomy. | Diagnostic test | total thyroidectomy patients |
Primary outcome
ionized calcium
Time frame: Preoperative baseline; postoperative 10 minutes; postoperative 6 hours
Ionized calcium levels will be measured by blood gas analysis at predefined preoperative and postoperative time points in patients undergoing total thyroidectomy.
parathormone levels
Time frame: Preoperative baseline; postoperative 10 minutes; postoperative 6 hours; and postoperative 6 months
Serum parathyroid hormone levels will be measured in patients undergoing total thyroidectomy to evaluate the association between postoperative parathyroid hormone changes and postoperative hypocalcemia.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
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NIRAF-Guided Parathyroid Identification During Thyroidectomy
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COMPARISON OF THE EFFICACY BETWEEN PREOPERATIVE CALCIUM & VITAMIN D3 VERSUS CALCIUM SUPPLEMENTATION ALONE TO PREVENT POST OPERATIVE SYMPTOMATIC HYPOCALCEMIA AFTER TOTAL THYROIDECTOMY IN EUTHYROID PATIENTS
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Hypocalcemia and Postoperative Hypoparathyroidism, run by Emrecan Deniz at 1 site in Turkey (Türkiye).
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 14 Jul 2026. 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 Turkey (Türkiye). 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ionized calcium (time frame: Preoperative baseline; postoperative 10 minutes; postoperative 6 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2026.