Preoperative Corticosteroids in Autoimmune Thyroid Disease
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
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
- Thyroid difficulty Scale score [through study completion, an average of 6 months]
8 points (best outcome) - 41 points (worst outcome)
- Calcium [through study completion, an average of 6 months]
Calcium, 8.5-10.5 mg/dL
- SF-12 [through study completion, an average of 6 months]
12 points (best outcome) to 48 points (worst outcome)
- PTH [through study completion, an average of 6 months]
PTH, 10-65 pg/mL
- TSH [through study completion, an average of 6 months]
TSH, 0.4-4.2 mcU/mL
- FT4 [through study completion, an average of 6 months]
FT4, 0.6-1.5 ng/dL
- TT3 [through study completion, an average of 6 months]
TT3, 82-179 ng/dL;
- Tg [through study completion, an average of 6 months]
Tg, 1.3-31.8 ng/mL;
- TgAB [through study completion, an average of 6 months]
TgAB, 0-4.0 IU/mL;
- TPO [through study completion, an average of 6 months]
TPO AB 0-9.0 IU/mL;
- TSI [through study completion, an average of 6 months]
TSI 0-0.54 IU/L;
- TRAb [through study completion, an average of 6 months]
TRAb 0-1.75 IU/L
- ThyPRO [through study completion, an average of 6 months]
0 points (best outcome) - 340 points (worst outcome)
Secondary Outcome Measures
- Ultrasound doppler quantification of blood flow [through study completion, an average of 6 months]
2 points (best outcome) -16 points (worst outcome)
- 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
- 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.- 10009