RecruitingPhase 4NCT05435547

Preoperative Corticosteroids in Autoimmune Thyroid Disease

Randomized Controlled Trial of Preoperative Corticosteroids in Autoimmune ThyroidDisease


Sponsor

Indiana University

Enrollment

76 participants

Start Date

Jun 16, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study proposes to randomize patients about to undergo surgery for their autoimmune, inflammatory thyroid disease, and determine if a short course of corticosteroids decreases the inflammation of the gland and makes surgery less difficult.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • ■ Graves' disease or Hashimoto's disease with positive thyroid autoantibodies (TgAb, TPO, TSI, and/or TRAb) undergoing total thyroidectomy for their disease.

Exclusion Criteria7

  • Pediatric patients \< 18
  • Prior treatment with RAI
  • Prior neck surgeries
  • Known diagnosis of thyroid cancer
  • Diabetic patients on medications
  • A history of adverse reactions to corticosteroids.
  • Patients on any immunosuppressive regimen (such as organ transplant patients or patients treated for other autoimmune conditions). This includes patients with recent history of steroid therapy, or a history of adverse reactions to corticosteroids.

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Interventions

DRUGDexamethasone

Will take Dexamethasone pre-operatively

DRUGPlacebo

Will take Placebo pre-operatively


Locations(3)

IU Health North Hospital

Indianapolis, Indiana, United States

IU Health Methodist Hospital

Indianapolis, Indiana, United States

IU Health University Hospital

Indianapolis, Indiana, United States

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