Improving Safety in Pediatric Thyroidectomy by PTH Measurements

NCT04690842 | Completed

• 1 other identifier: CEI 19.27
• Study Type: observational
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

We implemented a previously reported algorithm based on intra-postoperative PTH measurements with selected cut-off values, both to predict post-thyroidectomy hypoparathyroid hypocalcemia, and to guide postsurgical management. The objective of the study was to assess if this strategy was useful to reduce hypocalcemia, post-surgery calcium sampling and hospitalization length.

Conditions

Hypoparathyroidism Postprocedural

Keywords

Thyroidectomy; PTH; Pediatric surgery; hypocalcemia

Outcome Measures

Primary Outcomes (2)

• Biochemical hypocalcemia post thyroidectomy occurrence

  total Calcium level \< 8 mg/dl

  48 hours postthyroidectomy

• Symptomatic hypocalcemia post thyroidectomy ocurrence

  Signs o symptoms of hypocalcemia (Chvostek or Trousseau signs, tingling, numbness, muscle cramps, spasms, tetany or seizures

  48 hours posthyroidectomy

Secondary Outcomes (2)

• days of hospitalization after thyroidectomy

  up to 15 days after thyroidectomy

• number of Calcium sampling

  48 hours postthyroidectomy

Interventions

PTH measurements post-thyroidectomy (at 5 and 60 min post thyroid removal) DIAGNOSTIC_TEST

We implement an algorithm employing PTH levels post-thyroidectomy to stratify patients according to their postsurgical risk for hypoparathyroidism, and to distinctively manage them in the immediate postsurgical period. High risk patients are quickly supplemented with Calcium iv and activated 25OH vitamin D. Low risk patients are clinically controlled and calcium level were checked at 24 and 48 hs post thyroidectomy.

Eligibility Criteria

• Age: 2 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All patients between 2 and 19 years of age who underwent total thyroidectomy at Hospital de Niños Ricardo Gutiérrez in Buenos Aires, Argentina between January 2014 and April 2020 were included. Exclusion criteria were patients with known hyper or hypoparathyroidism, kidney failure, and those taking medications known to affect TCa, PTH, or vitamin D levels (octreotide, oral glucocorticoids, diuretics and antiepileptics), or any other condition that could interfere with calcium metabolism.

You may qualify if:

• Patients who underwent total thyroidectomy between January 2014 and April 2020

You may not qualify if:

• Patients with known hyper or hypoparathyroidism, kidney failure, and those taking medications known to affect TCa, PTH, or vitamin D levels (octreotide, oral glucocorticoids, diuretics and antiepileptics), or any other condition that could interfere with calcium metabolism

Sponsors & Collaborators

• Hospital de Niños R. Gutierrez de Buenos Aires: lead

Related Publications (1)

• Freire AV, Ropelato MG, Ballerini MG, Acha O, Bergada I, de Papendieck LG, Chiesa A. Predicting hypocalcemia after thyroidectomy in children. Surgery. 2014 Jul;156(1):130-6. doi: 10.1016/j.surg.2014.02.016. Epub 2014 Feb 27.

  PMID: 24929763 BACKGROUND

MeSH Terms

Conditions

Hypocalcemia

Condition Hierarchy (Ancestors)

Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Endocrinology, PhD

Study Record Dates

• First Submitted: December 28, 2020
• First Posted: December 31, 2020
• Study Start: June 1, 2014
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: January 6, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share