Is Correcting Total Serum Calcium Levels Important After Thyroidectomy

NCT04304573 | Unknown

• 1 other identifier: KBCSM13
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed as a prospective non-randomized longitudinal single- center cohort study to evaluate the importance of correcting total serum calcium levels. It will enroll around 100 patients undergoing total thyroidectomy with data being collected from March 2020 up to August 2020. The aim of this study is to determine whether total serum calcium level should be corrected for serum albumin in assessing symptomatic hypocalcemia after total thyroidectomy and which variable (total serum calcium, ionized calcium, corrected serum calcium for albumin with Payne's formula or early PTH) is the most valuable predictor of symptomatic hypocalcemia after total thyroidectomy.

Conditions

Hypocalcemia; Thyroid; Parathyroid Dysfunction; Calcium Disorder; Hormone Disturbance; Postoperative Complications

Keywords

hypocalcemia; total thyroidectomy; Payne's formula; ionized calcium; parathyroid hormone; predictive factor

Outcome Measures

Primary Outcomes (1)

• Corrected total serum calcium value

  Statistically significant correlation between low value of corrected total serum calcium level for albumin and hypocalcemia symptoms

  5 days

Secondary Outcomes (1)

• Administration of postoperative calcium supplement therapy

  5 days

Study Arms (2)

Patients with hypocalcemia symptoms and low serum calcium

Patients with postoperative hypocalcemia defined as serum calcium levels \< 2.00 mmol/L. Patients may have low or normal PTH range (defined by the Department of Laboratory Diagnostics reference range from 1.6 to 6.9 pmol/L)

Diagnostic Test: Total serum calcium blood test

Patients with hypocalcemia symptoms and normal serum calcium

Patients with hypocalcemia symptoms but without postoperative hypocalcemia defined as serum calcium levels \> 2.00 mmol/L. Patients may have low or normal PTH range (defined by the Department of Laboratory Diagnostics reference range from 1.6 to 6.9 pmol/L)

Diagnostic Test: Total serum calcium blood test

Interventions

Total serum calcium blood test DIAGNOSTIC_TEST

Total serum calcium measurements will be done on the first postoperative day. Also ionized calcium, corrected total serum calcium for serum albumin with Payne's formula and PTH will be monitored.

Patients with hypocalcemia symptoms and low serum calcium; Patients with hypocalcemia symptoms and normal serum calcium

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 regardless of the surgical indication.

You may qualify if:

• The patients were eligible if they underwent total thyroidectomy regardless of the surgical indication, if complete serum PTH and calcium data were available through the first five postoperative days and if they signed an informed consent form.

You may not qualify if:

• Patients with incomplete data, preoperative pathological calcium or PTH levels, or suffering from conditions affecting calcium metabolism and parathyroid function were excluded from the study.

Sponsors & Collaborators

• University Hospital Sestre Milosrdnice: lead

Study Sites (1)

University Hospital Center Sestre milosrdnice

Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Hypocalcemia; Thyroid Diseases; Parathyroid Diseases; Endocrine System Diseases; Postoperative Complications

Condition Hierarchy (Ancestors)

Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ivan Rašić, MD,PhD

  Department of Otorhinolaryngology and Head and Neck Surgery

  STUDY CHAIR

Central Study Contacts

Andro Košec, MD,PhD

CONTACT

+385989817156; andro.kosec@yahoo.com

Ana Gašić, MD

CONTACT

+385996879905; anagasic4@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Otorhinolaryngologist and Head and Neck Surgeon

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 11, 2020
• Study Start: June 9, 2020
• Primary Completion: August 9, 2020
• Study Completion: September 9, 2020
• Last Updated: March 30, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)