Preoperative Corticosteroids in Autoimmune Thyroid Disease

Sponsor
Indiana University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05435547
Collaborator
(none)
76
2
42

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
76 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Randomized Controlled Trial of Preoperative Corticosteroids in Autoimmune ThyroidDisease
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Steroids

Will be given pre-operative corticosteroid regimen

Drug: Dexamethasone
Will take Dexamethasone pre-operatively

Placebo Comparator: placebo

Will be given Placebo

Drug: Placebo
Will take Placebo pre-operatively

Outcome Measures

Primary Outcome Measures

  1. Thyroid difficulty Scale score [through study completion, an average of 6 months]

    8 points (best outcome) - 41 points (worst outcome)

  2. Calcium [through study completion, an average of 6 months]

    Calcium, 8.5-10.5 mg/dL

  3. SF-12 [through study completion, an average of 6 months]

    12 points (best outcome) to 48 points (worst outcome)

  4. PTH [through study completion, an average of 6 months]

    PTH, 10-65 pg/mL

  5. TSH [through study completion, an average of 6 months]

    TSH, 0.4-4.2 mcU/mL

  6. FT4 [through study completion, an average of 6 months]

    FT4, 0.6-1.5 ng/dL

  7. TT3 [through study completion, an average of 6 months]

    TT3, 82-179 ng/dL;

  8. Tg [through study completion, an average of 6 months]

    Tg, 1.3-31.8 ng/mL;

  9. TgAB [through study completion, an average of 6 months]

    TgAB, 0-4.0 IU/mL;

  10. TPO [through study completion, an average of 6 months]

    TPO AB 0-9.0 IU/mL;

  11. TSI [through study completion, an average of 6 months]

    TSI 0-0.54 IU/L;

  12. TRAb [through study completion, an average of 6 months]

    TRAb 0-1.75 IU/L

  13. ThyPRO [through study completion, an average of 6 months]

    0 points (best outcome) - 340 points (worst outcome)

Secondary Outcome Measures

  1. Ultrasound doppler quantification of blood flow [through study completion, an average of 6 months]

    2 points (best outcome) -16 points (worst outcome)

  2. Number of participants with the following surgical complications: [through study completion, an average of 6 months]

    Number of subjects with: Transient hypocalcemia (calcium <8.5), Post-op PTH <10, Transient nerve injury/voice hoarseness (<6 months), Wound complication, Hematoma, Hypocalcemia (Calcium <8.5) >6 months, Permanent nerve injury > 6 months, Vocal cord dysfunction seen on flexible laryngoscopy, ED visit, Readmission, Reintubation, Tracheostomy

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
  • 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

  • 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.

  • A history of adverse reactions to corticosteroids.

  • Patients who are receiving a concomitant medication that interacts negatively with corticosteroids.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Indiana University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alexandria D. McDow, Assistant Professor of Surgery, Indiana University
ClinicalTrials.gov Identifier:
NCT05435547
Other Study ID Numbers:
  • 10009
First Posted:
Jun 28, 2022
Last Update Posted:
Jun 28, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 28, 2022