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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05435547
Other study ID # 10009
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date June 16, 2023
Est. completion date December 31, 2025

Study information

Verified date December 2023
Source Indiana University
Contact Alexandria McDow, MD
Phone 317-944-4377
Email amcdow@iu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 76
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexamethasone
Will take Dexamethasone pre-operatively
Placebo
Will take Placebo pre-operatively

Locations

Country Name City State
United States IU Methodist Hospital Indianapolis Indiana
United States IU North Hospital Indianapolis Indiana
United States IU University Hospital Indianapolis Indiana

Sponsors (1)

Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Thyroid difficulty Scale score 8 points (best outcome) - 41 points (worst outcome) through study completion, an average of 6 months
Secondary Ultrasound doppler quantification of blood flow 2 points (best outcome) -16 points (worst outcome) through study completion, an average of 6 months
Secondary Number of participants with the following surgical complications: 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 through study completion, an average of 6 months
Secondary Calcium Calcium, 8.5-10.5 mg/dL through study completion, an average of 6 months
Secondary SF-12 12 points (best outcome) to 48 points (worst outcome) through study completion, an average of 6 months
Secondary PTH PTH, 10-65 pg/mL through study completion, an average of 6 months
Secondary TSH TSH, 0.4-4.2 mcU/mL through study completion, an average of 6 months
Secondary FT4 FT4, 0.6-1.5 ng/dL through study completion, an average of 6 months
Secondary TT3 TT3, 82-179 ng/dL; through study completion, an average of 6 months
Secondary Tg Tg, 1.3-31.8 ng/mL; through study completion, an average of 6 months
Secondary TgAB TgAB, 0-4.0 IU/mL; through study completion, an average of 6 months
Secondary TPO TPO AB 0-9.0 IU/mL; through study completion, an average of 6 months
Secondary TSI TSI 0-0.54 IU/L; through study completion, an average of 6 months
Secondary TRAb TRAb 0-1.75 IU/L through study completion, an average of 6 months
Secondary ThyPRO 0 points (best outcome) - 340 points (worst outcome) through study completion, an average of 6 months
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