Perioperative Parathormone Measurement and Sodium Bicarbonate Infusion Test After Total Thyroidectomy
Comparison of the Prognostic Value of Perioperative Parathormone Measurement and Sodium Bicarbonate Infusion Test in the Evaluation of Parathyroid Function After Total Thyroidectomy
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Thessaloniki, Grekland, 54636
- Ahepa University Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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total thyroidectomy
patients undergoing total thyroidectomy
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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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
Tidsram: 3 months
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3 months
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Samarbetspartners och utredare
Samarbetspartners
Utredare
- Studierektor: John G Yovos, MD, PhD, Aristotle University Of Thessaloniki
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- Iwasaki 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- APC00994614
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