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Perioperative Parathormone Measurement and Sodium Bicarbonate Infusion Test After Total Thyroidectomy

This study has been completed.
Sponsor:
Collaborator:
AHEPA University Hospital
Information provided by:
Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT00793689
First received: November 18, 2008
Last updated: October 15, 2009
Last verified: October 2009
History of Changes
  Purpose

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.


Condition
Hypoparathyroidism

Study Type: Observational
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • 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 ]

Enrollment: 127
Study Start Date: March 2008
Study Completion Date: October 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
total thyroidectomy
patients undergoing total thyroidectomy

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing total thyroidectomy

Criteria

Inclusion criteria for the patient group

  1. Patient is over 18 years old
  2. Patient scheduled for total thyroidectomy
  3. Patient signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures

Exclusion criteria the patient group:

  1. Primary hyperparathyroidism
  2. Primary hypoparathyroidism
  3. Diabetes mellitus
  4. Chronic Renal Failure
  5. Hypoalbuminemia
  6. Systematic Diseases (e.g., infections, neoplasmas)
  7. Thyroid or parathyroid cancer
  8. Osteoporosis
  9. Drugs that influence calcium metabolism (vitamin D analogues, oral calcium supplements, biphosphonates, teriparatide, thiazide diuretics)
  10. Osteomalacia
  11. Neck irradiation

Inclusion criteria for the control group

  1. Participant is over 18 years old
  2. 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00793689

Locations
Greece
AHEPA University Hospital
Thessaloniki, Greece, 54636
Sponsors and Collaborators
Aristotle University Of Thessaloniki
AHEPA University Hospital
Investigators
Study Director: John G Yovos, MD, PhD Aristotle University Of Thessaloniki
  More Information

Publications:

Responsible Party: John G. Yovos, Prof, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT00793689     History of Changes
Other Study ID Numbers: APC00994614
Study First Received: November 18, 2008
Last Updated: October 15, 2009
Health Authority: Greece: Ethics Committee

Keywords provided by Aristotle University Of Thessaloniki:
parathyroid
thyroidectomy
hypoparathyroidism
Parathyroid function after total thyroidectomy

Additional relevant MeSH terms:
Hypoparathyroidism
Parathyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013