Perioperative Parathormone Measurement and Sodium Bicarbonate Infusion Test After Total Thyroidectomy
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ClinicalTrials.gov Identifier: NCT00793689 |
Recruitment Status :
Completed
First Posted : November 19, 2008
Last Update Posted : October 16, 2009
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Condition or disease |
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Hypoparathyroidism |
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 Type : | Observational |
Actual Enrollment : | 127 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
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 |
Study Start Date : | March 2008 |
Actual Primary Completion Date : | September 2009 |
Actual Study Completion Date : | October 2009 |

Group/Cohort |
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total thyroidectomy
patients undergoing total thyroidectomy
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- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion criteria for the patient group
- 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
Exclusion criteria the patient group:
- Primary hyperparathyroidism
- Primary hypoparathyroidism
- Diabetes mellitus
- Chronic Renal Failure
- Hypoalbuminemia
- Systematic Diseases (e.g., infections, neoplasmas)
- Thyroid or parathyroid cancer
- Osteoporosis
- Drugs that influence calcium metabolism (vitamin D analogues, oral calcium supplements, biphosphonates, teriparatide, thiazide diuretics)
- Osteomalacia
- Neck irradiation
Inclusion criteria for the control group
- Participant is over 18 years old
- Participant signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures
Exclusion criteria of the control group:
1. All the above mentioned, in addition to prior thyroid surgery.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00793689
Greece | |
AHEPA University Hospital | |
Thessaloniki, Greece, 54636 |
Study Director: | John G Yovos, MD, PhD | Aristotle University Of Thessaloniki |
Responsible Party: | John G. Yovos, Prof, Aristotle University Of Thessaloniki |
ClinicalTrials.gov Identifier: | NCT00793689 |
Other Study ID Numbers: |
APC00994614 |
First Posted: | November 19, 2008 Key Record Dates |
Last Update Posted: | October 16, 2009 |
Last Verified: | October 2009 |
parathyroid thyroidectomy hypoparathyroidism Parathyroid function after total thyroidectomy |
Hypoparathyroidism Parathyroid Diseases Endocrine System Diseases |