HypoparathyroidismNCT00793689
Perioperative Parathormone Measurement and Sodium Bicarbonate Infusion Test After Total Thyroidectomy
An observational study of Hypoparathyroidism, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
In the study will be included patients that have undergone total thyroidectomy and do not display obvious clinical or laboratory hypoparathyroidism. On the third postoperative day and before the patient's exit from the hospital, the patient will undergo an intravenous infusion test with 35ml/m2 dilution of 8.4%(w/v)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoparathyroidism
- How many people
- 127 participants
- Where
- 1 siteGreece
- Study dates
- Mar 2008to Oct 2009
- 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
Who may be able to join
- Patient is over 18 years old
- Patient scheduled for total thyroidectomy
- Patient signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures
- Participant is over 18 years old
- Participant signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures
Who cannot join
- Primary hyperparathyroidism
- Primary hypoparathyroidism
- Diabetes mellitus
- Chronic Renal Failure
- Hypoalbuminemia
- Systematic Diseases (e.g., infections, neoplasmas)
Show all 12Show fewer
- Thyroid or parathyroid cancer
- Osteoporosis
- Drugs that influence calcium metabolism (vitamin D analogues, oral calcium supplements, biphosphonates, teriparatide, thiazide diuretics)
- Osteomalacia
- Neck irradiation
- 1. All the above mentioned, in addition to prior thyroid surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Prognostic Value of Perioperative Parathormone Measurement and Sodium Bicarbonate Infusion Test in the Evaluation of Parathyroid Function After Total Thyroidectomy
In the study will be included patients that have undergone total thyroidectomy and do not display obvious clinical or laboratory hypoparathyroidism. On the third postoperative day and before the patient's exit from the hospital, the patient will undergo an intravenous infusion test with 35ml/m2 dilution of 8.4%(w/v) sodium bicarbonate in two minutes. Three months after the operation, if the study conditions are still met, the patient will undergo an additional parathyroid hormone (PTH) measurement and sodium bicarbonate infusion test and the parathyroid function will be evaluated again.
Read the detailed description
Each patient will undergo a thorough preoperative examination for the presence of abnormalities in calcium, phosphate or magnesium metabolism as a consequence of a primary or a secondary disease.
Blood samples will be taken right before the beginning of the thyroidectomy, and 20 minutes after the end, to measure the PTH levels and to evaluate the variation rate.
On the third postoperative day and before the patient's exit from the hospital, the patient will undergo an intravenous infusion test with 35ml/m2 dilution of 8.4%(w/v) sodium bicarbonate in two minutes. Blood samples will be collected from a different vein at 0, 3, 5, 10, 30 and 60 minutes after infusion to measure PTH, calcium, phosphate and magnesium.
Three months after the operation, if the study conditions are still met, the patient will undergo an additional PTH measurement and sodium bicarbonate infusion test and the parathyroid function will be evaluated again.
In addition, the test will be performed on 50 healthy volunteers, in order to assess the response to the test of normal individuals.
- Conditions
- Hypoparathyroidism
- Keywords
- parathyroid, thyroidectomy, hypoparathyroidism, Parathyroid function after total thyroidectomy
- Medical subject headings
- Hypoparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| total thyroidectomy | patients undergoing total thyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the prognostic value in the evaluation of parathyroid function of perioperative PTH measurement and sodium bicarbonate infusion test after total thyroidectomy
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startMar 2008
- Primary completionSep 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypoparathyroidismStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- AHEPA University Hospital
- Investigators
- John G Yovos, MD, PhD, Study director, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793689
- Sponsor's protocol ID
- APC00994614
- Status last verified
- Oct 2009
- First submitted
- 18 Nov 2008
- Last updated
- 16 Oct 2009
- Results posted
- No
Publications
Warren FM, Andersen PE, Wax MK, Cohen JI. Perioperative parathyroid hormone levels in thyroid surgery: preliminary report. Laryngoscope. 2004 Apr;114(4):689-93. doi: 10.1097/00005537-200404000-00017.
PubMed 15064625Iwasaki Y, Mutsuga N, Yamamori E, Kakita A, Oiso Y, Imai T, Funahashi H, Tanaka Y, Kondo K, Nakashima N. Sodium bicarbonate infusion test: a new method for evaluating parathyroid function. Endocr J. 2003 Oct;50(5):545-51. doi: 10.1507/endocrj.50.545.
PubMed 14614210
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Prognostic Value of Perioperative Parathormone Measurement and Sodium Bicarbonate Infusion Test in the Evaluation of Parathyroid Function After Total Thyroidectomy
- ClinicalTrials.gov ID
- NCT00793689
- Acronym / sponsor ID
- APC00994614
- Conditions
- Hypoparathyroidism
- Keywords
- parathyroid, thyroidectomy, hypoparathyroidism, Parathyroid function after total thyroidectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- AHEPA University Hospital
- Study start
- Mar 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 19 Nov 2008 (estimated)
- 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.
In the study will be included patients that have undergone total thyroidectomy and do not display obvious clinical or laboratory hypoparathyroidism. On the third postoperative day and before the patient's exit from the hospital, the patient will undergo an intravenous infusion test with 35ml/m2 dilution of 8.4%(w/v) sodium bicarbonate in two minutes. Three months after the operation, if the study conditions are still met, the patient will undergo an additional parathyroid hormone (PTH) measurement and sodium bicarbonate infusion test and the parathyroid function will be evaluated again.
Detailed description
Each patient will undergo a thorough preoperative examination for the presence of abnormalities in calcium, phosphate or magnesium metabolism as a consequence of a primary or a secondary disease.
Blood samples will be taken right before the beginning of the thyroidectomy, and 20 minutes after the end, to measure the PTH levels and to evaluate the variation rate.
On the third postoperative day and before the patient's exit from the hospital, the patient will undergo an intravenous infusion test with 35ml/m2 dilution of 8.4%(w/v) sodium bicarbonate in two minutes. Blood samples will be collected from a different vein at 0, 3, 5, 10, 30 and 60 minutes after infusion to measure PTH, calcium, phosphate and magnesium.
Three months after the operation, if the study conditions are still met, the patient will undergo an additional PTH measurement and sodium bicarbonate infusion test and the parathyroid function will be evaluated again.
In addition, the test will be performed on 50 healthy volunteers, in order to assess the response to the test of normal individuals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| total thyroidectomy | – | –patients undergoing total thyroidectomy |
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
Key inclusion criteria (5 listed)
- Patient is over 18 years old
- Patient scheduled for total thyroidectomy
- Patient signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures
- Participant is over 18 years old
- Participant signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures
Key exclusion criteria (12 listed)
- Primary hyperparathyroidism
- Primary hypoparathyroidism
- Diabetes mellitus
- Chronic Renal Failure
- Hypoalbuminemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compare the prognostic value in the evaluation of parathyroid function of perioperative PTH measurement and sodium bicarbonate infusion test after total thyroidectomy
Time frame: 3 months
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 16 Oct 2009.
- Background: PubMed 15064625Warren FM, Andersen PE, Wax MK, Cohen JI. Perioperative parathyroid hormone levels in thyroid surgery: preliminary report. Laryngoscope. 2004 Apr;114(4):689-93. doi: 10.1097/00005537-200404000-00017.
- Background: PubMed 14614210Iwasaki Y, Mutsuga N, Yamamori E, Kakita A, Oiso Y, Imai T, Funahashi H, Tanaka Y, Kondo K, Nakashima N. Sodium bicarbonate infusion test: a new method for evaluating parathyroid function. Endocr J. 2003 Oct;50(5):545-51. doi: 10.1507/endocrj.50.545.
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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.
John G Yovos, MD, PhD study director
Aristotle University Of Thessaloniki
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 Hypoparathyroidism, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 12 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 16 Oct 2009. 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 Greece. 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?
Compare the prognostic value in the evaluation of parathyroid function of perioperative PTH measurement and sodium bicarbonate infusion test after total thyroidectomy (time frame: 3 months). 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 NCT00793689, which also lists 2 linked publications.
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 16 Oct 2009; AzTrials last refreshed its copy on 7 Nov 2026.