Perioperative Parathormone Measurement and Sodium Bicarbonate Infusion Test After Total Thyroidectomy

October 15, 2009 updated by: Aristotle University Of Thessaloniki

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

Study Overview

Status

Completed

Conditions

Hypoparathyroidism

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.

Study Type

Observational

Enrollment (Actual)

127

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Greece
- - Thessaloniki, Greece, 54636
    - Ahepa University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing total thyroidectomy

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
total thyroidectomy patients undergoing total thyroidectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Collaborators

AHEPA University Hospital

Investigators

Study Director: John G Yovos, MD, PhD, Aristotle University Of Thessaloniki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

November 18, 2008

First Submitted That Met QC Criteria