Perioperative Parathormone Measurement and Sodium Bicarbonate Infusion Test After Total Thyroidectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of the Prognostic Value of Perioperative Parathormone Measurement and Sodium Bicarbonate Infusion Test in the Evaluation of Parathyroid Function After Total Thyroidectomy

Conditions
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Hypoparathyroidism

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| total thyroidectomy<br>patients undergoing total thyroidectomy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the prognostic value in the evaluation of parathyroid function of perioperative PTH measurement and sodium bicarbonate infusion test after total thyroidectomy |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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parathyroid, thyroidectomy, hypoparathyroidism, Parathyroid function after total thyroidectomy