Perioperative Parathormone Measurement and Sodium Bicarbonate Infusion Test After Total Thyroidectomy

NCT00793689 | Completed

• 1 other identifier: APC00994614
• Study Type: observational
• Target: 127
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypoparathyroidism

Keywords

parathyroid; thyroidectomy; hypoparathyroidism; Parathyroid function after total thyroidectomy

Outcome Measures

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

  3 months

Study Arms (1)

total thyroidectomy

patients undergoing total thyroidectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing total thyroidectomy

You may qualify if:

• 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

You may not qualify if:

• 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
• Participant is over 18 years old
• Participant signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures
• \. All the above mentioned, in addition to prior thyroid surgery.

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• AHEPA University Hospital: collaborator

Study Sites (1)

AHEPA University Hospital

Thessaloniki, 54636, Greece

Location

Related Publications (2)

• 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.

  PMID: 15064625 BACKGROUND

• 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.

  PMID: 14614210 BACKGROUND

MeSH Terms

Conditions

Hypoparathyroidism

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases

Study Officials

• John G Yovos, MD, PhD

  Aristotle University Of Thessaloniki

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 18, 2008
• First Posted: November 19, 2008
• Study Start: March 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: October 1, 2009
• Last Updated: October 16, 2009

Record last verified: 2009-10

Locations

GR (1)