Using corticosteroids before surgery for autoimmune thyroid disease
Randomized Controlled Trial of Preoperative Corticosteroids in Autoimmune ThyroidDisease
PHASE4 · Indiana University · NCT05435547
This study tests if taking a short course of corticosteroids before thyroid surgery can help people with Graves' disease or Hashimoto's disease have a smoother operation.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Indiana University (other) |
| Locations | 3 sites (Indianapolis, Indiana and 2 other locations) |
| Trial ID | NCT05435547 on ClinicalTrials.gov |
What this trial studies
This study aims to randomize patients with Graves' disease or Hashimoto's disease who are scheduled for total thyroidectomy. It will evaluate whether a short course of corticosteroids, specifically dexamethasone, can reduce inflammation of the thyroid gland and facilitate a smoother surgical procedure. Participants will be compared against a placebo group to assess the effectiveness of the intervention. The study focuses on patients with positive thyroid autoantibodies undergoing surgery for their condition.
Who should consider this trial
Good fit: Ideal candidates are adults with Graves' disease or Hashimoto's disease who are preparing for total thyroidectomy and have positive thyroid autoantibodies.
Not a fit: Patients under 18, those with a history of thyroid cancer, or individuals on immunosuppressive therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and reduced complications for patients with autoimmune thyroid disease.
How similar studies have performed: While the specific approach of using corticosteroids preoperatively in this context is not widely tested, similar studies have shown promise in reducing inflammation in other surgical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
* Inclusion Criteria: ■ Graves' disease or Hashimoto's disease with positive thyroid autoantibodies (TgAb, TPO, TSI, and/or TRAb) undergoing total thyroidectomy for their disease. * Exclusion Criteria: * 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.
Where this trial is running
Indianapolis, Indiana and 2 other locations
- IU Health North Hospital — Indianapolis, Indiana, United States (RECRUITING)
- IU Health Methodist Hospital — Indianapolis, Indiana, United States (RECRUITING)
- IU Health University Hospital — Indianapolis, Indiana, United States (RECRUITING)
Study contacts
- Principal investigator: Alexandria McDow, MD — Indiana University
- Study coordinator: Alexandria McDow, MD
- Email: amcdow@iu.edu
- Phone: 317-944-4377
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Graves Disease, Hashimoto Disease