HypocalcemiaNCT04304573
Is Correcting Total Serum Calcium Levels Important After Thyroidectomy
An observational study of Hypocalcemia and Thyroid, run by University Hospital Sestre Milosrdnice at 1 site in Croatia.
Trial summary
This study is designed as a prospective non-randomized longitudinal single- center cohort study to evaluate the importance of correcting total serum calcium levels. It will enroll around 100 patients undergoing total thyroidectomy with data being collected from March 2020 up to August 2020. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypocalcemia, Thyroid, Parathyroid Dysfunction
- What is being tested?
- Total serum calcium blood test
- How many people
- 100 participants
- Where
- 1 siteCroatia
- Study dates
- 9 Jun 2020to 9 Sep 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing total thyroidectomy regardless of the surgical indication.
Who may be able to join
- The patients were eligible if they underwent total thyroidectomy regardless of the surgical indication, if complete serum PTH and calcium data were available through the first five postoperative days and if they signed an informed consent form.
Who cannot join
- Patients with incomplete data, preoperative pathological calcium or PTH levels, or suffering from conditions affecting calcium metabolism and parathyroid function were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Croatia1 site
University Hospital Center Sestre milosrdnice
Zagreb, 10000
Andro Košec, MD, PhD, +385989817156, andro.kosec@yahoo.com
Ana Gašić, MD, +385996879905, anagasic4@gmail.com
About this study
Official title: Is Correcting Total Serum Calcium Levels for Serum Albumin Necessary in Assessing Symptomatic Hypocalcemia After Total Thyroidectomy: a Prospective Cohort Study
This study is designed as a prospective non-randomized longitudinal single- center cohort study to evaluate the importance of correcting total serum calcium levels. It will enroll around 100 patients undergoing total thyroidectomy with data being collected from March 2020 up to August 2020. The aim of this study is to determine whether total serum calcium level should be corrected for serum albumin in assessing symptomatic hypocalcemia after total thyroidectomy and which variable (total serum calcium, ionized calcium, corrected serum calcium for albumin with Payne's formula or early PTH) is the most valuable predictor of symptomatic hypocalcemia after total thyroidectomy.
Read the detailed description
This study is designed as a prospective non-randomized longitudinal single- center cohort study to evaluate the importance of correcting total serum calcium levels. It will enroll around 100 patients undergoing total thyroidectomy with data being collected from March 2020 up to August 2020.The patients will be eligible if they undergo total thyroidectomy regardless of the surgical indication, if complete serum PTH and calcium data are available through the first five postoperative days and if they sign an informed consent form. Patients with incomplete data, preoperative pathological calcium or PTH levels, or suffering from conditions affecting calcium metabolism and parathyroid function will be excluded from the study.
Demographic and clinical data including age, sex, preoperative and postoperative laboratory values (total serum calcium, ionized calcium, corrected total serum calcium for serum albumin and PTH), neck dissection procedures, and postoperative calcium supplement therapy will be noted.
Primary outcome measures are presence of hypocalcemia on the first and fifth postoperative day. Secondary outcome measures are the need for calcium supplement therapy during the first five postoperative days, amount of medication given and correlation between presence of symptoms and low values of corrected total serum calcium levels. Preoperative blood samples for serum PTH and calcium measurements will be obtained after hospital admission. Postoperative serum PTH will be sampled 1 hour after surgery and at 7 am on the firstand fifth postoperative day. Serum calcium sampling will be performed daily if a patient has hypocalcemia detected on the first postoperative day. Hypocalcemia is defined as serum calcium levels < 2.00 mmol/L regardless of clinical symptoms present. Normal PTH range is defined by the Department of Laboratory Diagnostics reference range - from 1.6 to 6.9 pmol/L. The recovery of parathyroid function is defined as the return of serum PTH and serum calcium to normal values, requiring no further calcium or vitamin D supplementation. If the patient does not have laboratory or clinical signs of hypocalcemia, calcium supplement therapy will not be administered. Supplement therapy will be administered in patients with laboratory findings confirming hypocalcemia. Supplement therapy consists of either peroral elemental calcium (calcium carbonate, 1-gram unit) or calcitriol (0.5 microgram unit) or both. If postoperative calcium and PTH are normal and there are no symptoms of discomfort, the patient will be discharged on the first or second postoperative day and serum PTH and calcium sampling will be performed on an outpatient basis. If the patient did not receive treatment during hospitalization, no supplements will be prescribed after hospital discharge.
- Conditions
- Hypocalcemia, Thyroid, Parathyroid Dysfunction, Calcium Disorder, Hormone Disturbance, Postoperative Complications
- Being tested
- Total serum calcium blood test
- Keywords
- hypocalcemia, total thyroidectomy, Payne's formula, ionized calcium, parathyroid hormone, predictive factor
- Medical subject headings
- Hypocalcemia, Thyroid Diseases, Parathyroid Diseases, Endocrine System Diseases, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total serum calcium blood testDiagnostic test
Total serum calcium measurements will be done on the first postoperative day. Also ionized calcium, corrected total serum calcium for serum albumin with Payne's formula and PTH will be monitored.
| Study group | Role | What they receive |
|---|---|---|
| Patients with hypocalcemia symptoms and low serum calcium | Patients with postoperative hypocalcemia defined as serum calcium levels < 2.00 mmol/L. Patients may have low or normal PTH range (defined by the Department of Laboratory Diagnostics reference range from 1.6 to 6.9 pmol/L) Receives: Diagnostic Test: Total serum calcium blood test | |
| Patients with hypocalcemia symptoms and normal serum calcium | Patients with hypocalcemia symptoms but without postoperative hypocalcemia defined as serum calcium levels > 2.00 mmol/L. Patients may have low or normal PTH range (defined by the Department of Laboratory Diagnostics reference range from 1.6 to 6.9 pmol/L) Receives: Diagnostic Test: Total serum calcium blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corrected total serum calcium value
Statistically significant correlation between low value of corrected total serum calcium level for albumin and hypocalcemia symptoms
Measured: 5 days
Secondary outcomes (1)
Administration of postoperative calcium supplement therapy
Whether or not, and the amount of postoperative calcium supplement therapy needed in case of hypocalcemia.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start9 Jun 2020 (estimated)
- Primary completion9 Aug 2020 (estimated)
- Study completion9 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Sestre Milosrdnice
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andro Košec, MD, PhD, University Hospital
- Investigators
- Ivan Rašić, MD,PhD, Study chair, Department of Otorhinolaryngology and Head and Neck Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304573
- Sponsor's protocol ID
- KBCSM13
- Status last verified
- Mar 2020
- First submitted
- 9 Mar 2020
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Correcting Total Serum Calcium Levels for Serum Albumin Necessary in Assessing Symptomatic Hypocalcemia After Total Thyroidectomy: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04304573
- Acronym / sponsor ID
- KBCSM13
- Conditions
- Hypocalcemia, Thyroid, Parathyroid Dysfunction, Calcium Disorder, Hormone Disturbance, Postoperative Complications
- Keywords
- hypocalcemia, total thyroidectomy, Payne's formula, ionized calcium, parathyroid hormone, predictive factor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital Sestre MilosrdniceUniversity, hospital or other
- Study start
- 9 Jun 2020 (estimated)
- Primary completion
- 9 Aug 2020 (estimated)
- Study completion
- 9 Sep 2020 (estimated)
- First posted
- 11 Mar 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.
This study is designed as a prospective non-randomized longitudinal single- center cohort study to evaluate the importance of correcting total serum calcium levels. It will enroll around 100 patients undergoing total thyroidectomy with data being collected from March 2020 up to August 2020. The aim of this study is to determine whether total serum calcium level should be corrected for serum albumin in assessing symptomatic hypocalcemia after total thyroidectomy and which variable (total serum calcium, ionized calcium, corrected serum calcium for albumin with Payne's formula or early PTH) is the most valuable predictor of symptomatic hypocalcemia after total thyroidectomy.
Detailed description
This study is designed as a prospective non-randomized longitudinal single- center cohort study to evaluate the importance of correcting total serum calcium levels. It will enroll around 100 patients undergoing total thyroidectomy with data being collected from March 2020 up to August 2020.The patients will be eligible if they undergo total thyroidectomy regardless of the surgical indication, if complete serum PTH and calcium data are available through the first five postoperative days and if they sign an informed consent form. Patients with incomplete data, preoperative pathological calcium or PTH levels, or suffering from conditions affecting calcium metabolism and parathyroid function will be excluded from the study.
Demographic and clinical data including age, sex, preoperative and postoperative laboratory values (total serum calcium, ionized calcium, corrected total serum calcium for serum albumin and PTH), neck dissection procedures, and postoperative calcium supplement therapy will be noted.
Primary outcome measures are presence of hypocalcemia on the first and fifth postoperative day. Secondary outcome measures are the need for calcium supplement therapy during the first five postoperative days, amount of medication given and correlation between presence of symptoms and low values of corrected total serum calcium levels. Preoperative blood samples for serum PTH and calcium measurements will be obtained after hospital admission. Postoperative serum PTH will be sampled 1 hour after surgery and at 7 am on the firstand fifth postoperative day. Serum calcium sampling will be performed daily if a patient has hypocalcemia detected on the first postoperative day. Hypocalcemia is defined as serum calcium levels < 2.00 mmol/L regardless of clinical symptoms present. Normal PTH range is defined by the Department of Laboratory Diagnostics reference range - from 1.6 to 6.9 pmol/L. The recovery of parathyroid function is defined as the return of serum PTH and serum calcium to normal values, requiring no further calcium or vitamin D supplementation. If the patient does not have laboratory or clinical signs of hypocalcemia, calcium supplement therapy will not be administered. Supplement therapy will be administered in patients with laboratory findings confirming hypocalcemia. Supplement therapy consists of either peroral elemental calcium (calcium carbonate, 1-gram unit) or calcitriol (0.5 microgram unit) or both. If postoperative calcium and PTH are normal and there are no symptoms of discomfort, the patient will be discharged on the first or second postoperative day and serum PTH and calcium sampling will be performed on an outpatient basis. If the patient did not receive treatment during hospitalization, no supplements will be prescribed after hospital discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with hypocalcemia symptoms and low serum calcium | – | Diagnostic Test: Total serum calcium blood testPatients with postoperative hypocalcemia defined as serum calcium levels < 2.00 mmol/L. Patients may have low or normal PTH range (defined by the Department of Laboratory Diagnostics reference range from 1.6 to 6.9 pmol/L) |
| Patients with hypocalcemia symptoms and normal serum calcium | – | Diagnostic Test: Total serum calcium blood testPatients with hypocalcemia symptoms but without postoperative hypocalcemia defined as serum calcium levels > 2.00 mmol/L. Patients may have low or normal PTH range (defined by the Department of Laboratory Diagnostics reference range from 1.6 to 6.9 pmol/L) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing total thyroidectomy regardless of the surgical indication.
Key inclusion criteria (1 listed)
- The patients were eligible if they underwent total thyroidectomy regardless of the surgical indication, if complete serum PTH and calcium data were available through the first five postoperative days and if they signed an informed consent form.
Key exclusion criteria (1 listed)
- Patients with incomplete data, preoperative pathological calcium or PTH levels, or suffering from conditions affecting calcium metabolism and parathyroid function were excluded from the study.
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 |
|---|---|---|
| Total serum calcium blood testTotal serum calcium measurements will be done on the first postoperative day. Also ionized calcium, corrected total serum calcium for serum albumin with Payne's formula and PTH will be monitored. | Diagnostic test | Patients with hypocalcemia symptoms and low serum calcium, Patients with hypocalcemia symptoms and normal serum calcium |
Primary outcome
Corrected total serum calcium value
Time frame: 5 days
Statistically significant correlation between low value of corrected total serum calcium level for albumin and hypocalcemia symptoms
1 secondary outcome
Administration of postoperative calcium supplement therapy
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Ivan Rašić, MD,PhD study chair
Department of Otorhinolaryngology and Head and Neck Surgery
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 Hypocalcemia and Thyroid, run by University Hospital Sestre Milosrdnice at 1 site in Croatia.
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 1 inclusion and 1 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 30 Mar 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 Croatia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andro Košec, MD,PhD (+385989817156, andro.kosec@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corrected total serum calcium value (time frame: 5 days). 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 30 Mar 2020.