Steroids in the Postoperative Transient Hypoparathyroidism Total Thyroidectomy (Corthyroid)

• ClinicalTrials.gov Identifier: NCT02652884
• Recruitment Status: Unknown
• First Posted: January 12, 2016
• Last Update Posted: April 5, 2016
• Sponsor: Hospital Italiano de Buenos Aires
• Information provided by (Responsible Party): Hospital Italiano de Buenos Aires

Tracking Information

• First Submitted Date: January 5, 2016
• First Posted Date: January 12, 2016
• Last Update Posted Date: April 5, 2016
• Study Start Date: January 2016
• Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 11, 2016)

Postoperative Hypocalcemia [ Time Frame: 3 days ]

Serial postoperative blood samples will be made to detect hypocalcemia (defined as <8,5 mg/dL)

1. at 1 hour postoperative from skin closure,
2. at 6 hours after surgery
3. 24 hours
4. 72 hours

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 11, 2016)

Related Adverse Events [ Time Frame: 30 days ]

Any negative effects of corticosteroids will be also recorded in the postoperative and during 30 days follow up after surgery. Major side effects associated with glucocorticoid therapy are: Gastrointestinal (Gastritis, Peptic ulcer disease, Pancreatitis, Steatohepatitis, Visceral perforation) Dermatologic and soft tissue (Skin thinning and purpura) Cardiovascular (Arrhythmias, Hypertension, Hypotension)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Steroids in the Postoperative Transient Hypoparathyroidism Total Thyroidectomy
• Official Title: Evaluation of Potential Benefits of Using Steroids in the Postoperative Transient Hypoparathyroidism Total Thyroidectomy

Brief Summary

The incidence of thyroid cancer (TC) has increased exponentially worldwide. The increase in diagnosed cases brings about an increase in the number of surgeries performed on the thyroid gland, especially total thyroidectomy (TT), given that at present is still the gold standard of treatment.

Transient postoperative hypoparathyroidism (HPT) is one of the most frequent complications, with an incidence of between 10 and 46% according to different sources. HPT involves longer hospital stay, serial measurements of blood glucose, treatment with calcium and vitamin D (with potential risk of hypercalcemia) and therefore an increase in terms of the costs of the health system.

While the investigators know the analgesic, anti-inflammatory, immunomodulatory and anti emetic of corticosteroids in thyroid surgery, the literature available to date is discordant in the use of steroid and its interaction with the HPT making clear the need for randomized clinical trials specific to analyze these variables more accurately.

As inflammation and edema constitute a proposed surgical manipulation in the pathogenesis of HPT component, investigators decided t conduct a prospective randomized, triple-blind, in order to assess the potential benefits of the most common postoperative complication reported in TT.

Our primary objective is to evaluate the safety and efficacy of single-dose corticosteroids deposit immediately postintubation in preventing the development of transient hypoparathyroidism (PTH, serum calcium and symptoms) in patients after TT.

• Detailed Description: Triple-blind randomized clinical trial
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Transient Hypoparathyroidism

Intervention

• Drug: phosphate and betamethasone acetate, 2 mL.
  single dose of intramuscular depot corticosteroid
  Other Name: cronodose
• Drug: saline 0.9% NaCl
  single dose of intramuscular placebo
  Other Name: placebo

Study Arms

• Experimental: Group 1
  will receive single dose intramuscular corticosteroid deltoid deposit (as phosphate and betamethasone acetate, 2 mL) for immediate postintubation.
  Intervention: Drug: phosphate and betamethasone acetate, 2 mL.
• Placebo Comparator: Group 2
  will receive 2 ml saline 0.9% NaCl in deltoid immediately postintubation.
  Intervention: Drug: saline 0.9% NaCl

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 11, 2016): 110
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2017
• Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• adult
• thyroidectomy postoperative
• prepaid affiliate patients

Exclusion Criteria:

• allergy
• CKD
• idiophatic thrombocytopenic purpura
• hyperthyroidism
• chronic use of corticoids
• no follicular cancer, nonpapillary
• refusal to participate

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina

Administrative Information

• NCT Number: NCT02652884
• Other Study ID Numbers: 2627
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Hospital Italiano de Buenos Aires
• Original Responsible Party: Same as current
• Current Study Sponsor: Hospital Italiano de Buenos Aires
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Juan Achaval, MD; Hospital Italiano de Buenos Aires
• Principal Investigator: Figari Marcelo, MD; Hospital Italiano de Buenos Aires

• PRS Account: Hospital Italiano de Buenos Aires
• Verification Date: January 2016