Is There Benefit From Early Postoperative PTH Monitoring?

NCT04160637 | Unknown

• 1 other identifier: EP-PTH01
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed as a prospective non-randomized longitudinal single-center cohort study. It will enroll around 120 patients undergoing total thyroidectomy with data being collected from September 2019 up to December 2019. The hypothesis is that a significant association and cut-off point in PTH levels may be established with regard to postoperativne hypocalcaemia. Primary outcome measures are presence of hypocalcemia on the first and fifth postoperative day. Secondary outcome measures are the need for calcium supplement therapy during the first five postoperative days and amount of medication given. Associations between variables will be assessed using Spearman's rho rank correlation coefficient, the Kruskal-Wallis test for independent samples and a logistic regression model to test statistically significant correlations between PTH and serum calcium values as a primary end point.

Conditions

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

Keywords

parathyroid hormone; total thyroidectomy; hypocalcemia; postoperative; predictive factor

Outcome Measures

Primary Outcomes (1)

• Cut-off PTH post-thyroidectomy value

  Statistically significant correlation between postoperative PTH and serum calcium values

  5 days

Secondary Outcomes (1)

• Administration of postoperative calcium supplement therapy

  5 days

Study Arms (2)

Patients with post-thyroidectomy hypocalcemia

Patients with postoperative hypocalcemia defined as serum calcium levels \< 2.00 mmol/L regardless of clinical symptoms present. 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: Immediate postoperative PTH serum sampling and cut-off value identification

Patients without post-thyroidectomy hypocalcemia

Patients without postoperative hypocalcemia defined as serum calcium levels \> 2.00 mmol/L regardless of clinical symptoms present. 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: Immediate postoperative PTH serum sampling and cut-off value identification

Interventions

Immediate postoperative PTH serum sampling and cut-off value identification DIAGNOSTIC_TEST

The patients will undergo immediate post-thyroidectomy PTH sampling in order to establish a cut-off value for identifying patients at risk for postoperative hypocalcemia within the first 5 postoperative days.

Patients with post-thyroidectomy hypocalcemia; Patients without post-thyroidectomy hypocalcemia

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

RECRUITING

MeSH Terms

Conditions

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

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

Filip Matovinović, MD

CONTACT

013787409; filip.matovinovic@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: November 9, 2019
• First Posted: November 13, 2019
• Study Start: September 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 31, 2019
• Last Updated: November 14, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)