Perioperative Parathormone Measurement and Sodium Bicarbonate Infusion Test After Total Thyroidectomy
NCT ID: NCT00793689
Last Updated: 2009-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
127 participants
OBSERVATIONAL
2008-03-31
2009-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Study of a Safe and Cost-effective Method to Identify Patients at Low Risk of Significant Hypocalcemia After Total Thyroidectomy.
NCT01027091
Does Indocyanine Imaging Scoring Predicts Postoperative Parathormone Levels at 24 Hours After Total Thyroidectomy
NCT03910049
Steroids in the Postoperative Transient Hypoparathyroidism Total Thyroidectomy
NCT02652884
Postoperative Dose of Parathyroid Hormone as a Marker for the Occurrence of Hypoparathyroidism After Total Thyroidectomy
NCT02924532
Is There Benefit From Early Postoperative PTH Monitoring?
NCT04160637
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
total thyroidectomy
patients undergoing total thyroidectomy
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
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
1\. All the above mentioned, in addition to prior thyroid surgery.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AHEPA University Hospital
OTHER
Aristotle University Of Thessaloniki
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Aristotle University Of Thessaloniki
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
John G Yovos, MD, PhD
Role: STUDY_DIRECTOR
Aristotle University Of Thessaloniki
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
AHEPA University Hospital
Thessaloniki, , Greece
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
APC00994614
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.