Improving Safety in Pediatric Thyroidectomy by PTH Measurements

Hypoparathyroidism Postprocedural Clinical Trial

Official title:

Implementation of PTH Measurement Intra / Post Thyroidectomy to Improve Post Surgical Safety in Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04690842
• Other study ID #: CEI 19.27
• Status: Completed
• Start date: June 2014
• Est. completion date: April 2020

Study information

• Verified date: January 2021
• Source: Hospital de Niños R. Gutierrez de Buenos Aires
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Sixty-six patients were included in the analysis. Based on their intra-operatory PTH determinations, patients were classified according to their post-surgical hypoparathyroidism risk and were either immediately treated with calcium and vitamin D1-25 supplementation (high-risk) or assigned to clinical control and routine calcium sampling (low-risk). The outcomes and overall results of these therapeutical approaches were compared with those of a control group, started on treatment when TCa levels dropped below normal.

In the high-risk subgroup (n=30) five patients showed hypocalcemia within the first 24 hours. Compared with the high-risk control subgroup, the incidence of hypocalcemia fell from 100% to 17% (p<0.001), and the median hospitalization length from 6 to 3 days (p<0.001).

In the low-risk subgroup (n=36) 28 patients remained normocalcemic with significantly less calcium sampling (p<0.001). Eight patients had hypocalcemia; 7 of them required neck dissection, which was the only risk factor related to post-surgical hypoparathyroidism (RR: 2.1 [CI 95% 1.4-3.1], P<0.001).

Compared to the control group, overall incidence of hypocalcemia was reduced by 58 %.

This approach improved patient's safety by reducing the occurrence of hypocalcemia and the length of hospitalization after thyroidectomy in pediatric patients. Preventive calcium supplementation seems to be more beneficial in patients undergoing neck dissection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 19 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hypoparathyroidism
• Hypoparathyroidism Postprocedural

Intervention

Diagnostic Test:
• PTH measurements post-thyroidectomy (at 5 and 60 min post thyroid removal)
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Niños R. Gutierrez de Buenos Aires

References & Publications (1)

Freire AV, Ropelato MG, Ballerini MG, Acha O, Bergadá 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical hypocalcemia post thyroidectomy occurrence	total Calcium level < 8 mg/dl	48 hours postthyroidectomy
Primary	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	days of hospitalization after thyroidectomy	number of days that patient need hospitalization (high risk group)	up to 15 days after thyroidectomy
Secondary	number of Calcium sampling	number of venipuncture performed to control serum calcium level (low risk group)	48 hours postthyroidectomy