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Preoperative Corticosteroids in Autoimmune Thyroid Disease

Primary Purpose

Graves Disease, Hashimoto Disease

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dexamethasone
Placebo
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Graves Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Steroids

    placebo

    Arm Description

    Will be given pre-operative corticosteroid regimen

    Will be given Placebo

    Outcomes

    Primary Outcome Measures

    Thyroid difficulty Scale score
    8 points (best outcome) - 41 points (worst outcome)

    Secondary Outcome Measures

    Ultrasound doppler quantification of blood flow
    2 points (best outcome) -16 points (worst outcome)
    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
    Calcium
    Calcium, 8.5-10.5 mg/dL
    SF-12
    12 points (best outcome) to 48 points (worst outcome)
    PTH
    PTH, 10-65 pg/mL
    TSH
    TSH, 0.4-4.2 mcU/mL
    FT4
    FT4, 0.6-1.5 ng/dL
    TT3
    TT3, 82-179 ng/dL;
    Tg
    Tg, 1.3-31.8 ng/mL;
    TgAB
    TgAB, 0-4.0 IU/mL;
    TPO
    TPO AB 0-9.0 IU/mL;
    TSI
    TSI 0-0.54 IU/L;
    TRAb
    TRAb 0-1.75 IU/L
    ThyPRO
    0 points (best outcome) - 340 points (worst outcome)

    Full Information

    First Posted
    January 25, 2022
    Last Updated
    May 16, 2023
    Sponsor
    Indiana University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05435547
    Brief Title
    Preoperative Corticosteroids in Autoimmune Thyroid Disease
    Official Title
    Randomized Controlled Trial of Preoperative Corticosteroids in Autoimmune ThyroidDisease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2025 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Indiana University

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Graves Disease, Hashimoto Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    76 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Steroids
    Arm Type
    Experimental
    Arm Description
    Will be given pre-operative corticosteroid regimen
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Will be given Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone
    Intervention Description
    Will take Dexamethasone pre-operatively
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Will take Placebo pre-operatively
    Primary Outcome Measure Information:
    Title
    Thyroid difficulty Scale score
    Description
    8 points (best outcome) - 41 points (worst outcome)
    Time Frame
    through study completion, an average of 6 months
    Secondary Outcome Measure Information:
    Title
    Ultrasound doppler quantification of blood flow
    Description
    2 points (best outcome) -16 points (worst outcome)
    Time Frame
    through study completion, an average of 6 months
    Title
    Number of participants with the following surgical complications:
    Description
    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
    Time Frame
    through study completion, an average of 6 months
    Title
    Calcium
    Description
    Calcium, 8.5-10.5 mg/dL
    Time Frame
    through study completion, an average of 6 months
    Title
    SF-12
    Description
    12 points (best outcome) to 48 points (worst outcome)
    Time Frame
    through study completion, an average of 6 months
    Title
    PTH
    Description
    PTH, 10-65 pg/mL
    Time Frame
    through study completion, an average of 6 months
    Title
    TSH
    Description
    TSH, 0.4-4.2 mcU/mL
    Time Frame
    through study completion, an average of 6 months
    Title
    FT4
    Description
    FT4, 0.6-1.5 ng/dL
    Time Frame
    through study completion, an average of 6 months
    Title
    TT3
    Description
    TT3, 82-179 ng/dL;
    Time Frame
    through study completion, an average of 6 months
    Title
    Tg
    Description
    Tg, 1.3-31.8 ng/mL;
    Time Frame
    through study completion, an average of 6 months
    Title
    TgAB
    Description
    TgAB, 0-4.0 IU/mL;
    Time Frame
    through study completion, an average of 6 months
    Title
    TPO
    Description
    TPO AB 0-9.0 IU/mL;
    Time Frame
    through study completion, an average of 6 months
    Title
    TSI
    Description
    TSI 0-0.54 IU/L;
    Time Frame
    through study completion, an average of 6 months
    Title
    TRAb
    Description
    TRAb 0-1.75 IU/L
    Time Frame
    through study completion, an average of 6 months
    Title
    ThyPRO
    Description
    0 points (best outcome) - 340 points (worst outcome)
    Time Frame
    through study completion, an average of 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alexandria McDow, MD
    Phone
    317-944-4377
    Email
    amcdow@iu.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Joseph Calcagno, BS
    Phone
    3172743121
    Email
    jcalcagn@iu.edu

    12. IPD Sharing Statement

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    Preoperative Corticosteroids in Autoimmune Thyroid Disease

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