Perioperative Parathormone Measurement and Sodium Bicarbonate Infusion Test After Total Thyroidectomy
|Study Design:||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|
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||March 2008|
|Study Completion Date:||October 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
patients undergoing total thyroidectomy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00793689
|AHEPA University Hospital|
|Thessaloniki, Greece, 54636|
|Study Director:||John G Yovos, MD, PhD||Aristotle University Of Thessaloniki|