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Completed

NCT Number: NCT00793689

Perioperative Parathormone Measurement and Sodium Bicarbonate Infusion Test 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AHEPA University Hospital

Thessaloniki, 54636, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • All the above mentioned, in addition to prior thyroid surgery.

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Collaborators

  • AHEPA University Hospital

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 19, 2008
Registry last updated
Oct 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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