Preoperative Corticosteroids in Autoimmune Thyroid Disease

Graves Disease Clinical Trial

Official title:

Randomized Controlled Trial of Preoperative Corticosteroids in Autoimmune ThyroidDisease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05435547
• Other study ID #: 10009
• Status: Recruiting
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Graves Disease
• Hashimoto Disease

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