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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Andro Košec, MD,PhD contact

+385989817156

andro.kosec@yahoo.com

Ana Gašić, MD contact

+385996879905

anagasic4@gmail.com

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

Other trials in Croatia

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.

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 groups in NCT04304573
Study groupRoleWhat they receive
Patients with hypocalcemia symptoms and low serum calciumPatients 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 calciumPatients 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.

  1. 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)
  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.

  1. First posted11 Mar 2020
  2. Study start9 Jun 2020 (estimated)
  3. Primary completion9 Aug 2020 (estimated)
  4. Study completion9 Sep 2020 (estimated)

Resources

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)
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

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.

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