Graves Disease
Conditions
Brief summary
The purpose of this research is to find out if SSKI (Potassium Iodide) reduces vascularity (the number and concentration of blood vessels) and improves how well patients do after surgery for removal of their whole thyroid gland in Graves' disease (an autoimmune disease that is a common cause of hyperthyroidism).
Detailed description
Patients with Graves' disease and goiters tend to have very vascular thyroid glands, which increases operative bleeding risks/rates. Many surgeons treat these patients with preoperative SSKI which is believed to decrease the vascularity, which in turn may decrease bleeding risks. However, there has been no quantitative data published on whether this is a real effect with true clinical benefit, in either animal or human models with SSKI. There have been some studies in Europe studying Lugol's solution, a different formulation of iodine, which show some decreased vascularity using color Doppler or measurements of CD34 cells.
Interventions
DRUGSSKI- Potassium Iodide
1g/mL, 2 drops orally 3 times a day for 7 days before surgery
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
All participants complete a baseline neck ultrasound no less than 7 days prior to surgery, to obtain vascular flow imaging. Participants are then randomized to receive 7 days of pre-operative SSKI or not receive any drug. In the practice at Columbia, all patients with Graves' disease receive SSKI preoperatively, though this is not standard practice across the country, thus the 'no drug' group is experimental for research. All participants complete a second ultrasound on the operating table before surgery, to assess for change in vascularity (experimental, as not all patients receive intra-operative ultrasounds before surgery). Both ultrasounds are performed by the surgeon.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* individuals diagnosed with Graves' disease undergoing total thyroidectomy for cure of disease.
Exclusion criteria
* no Graves' disease * \< 18 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Vascular Flow From Baseline | From Baseline to Immediately Before Surgery | Using 3D imaging software, the investigators will quantify the vascular flow in the ultrasound images and compare baseline images with the operating room (OR) images to assess if there is a difference in vascular flow between those timepoints. Vascular flow will be quantified using percent (%) surface area. This calculation will be done by a computer algorithm. |
Countries
United States
Participant flow
Pre-assignment details
2 participants withdrew from the study prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| SSKI (Potassium Iodide) Participants randomized to receive 7 days of pre-operative SSKI
SSKI- Potassium Iodide: 1g/mL, 2 drops orally 3 times a day for 7 days before surgery | 16 |
| NO SSKI Participants randomized to not receive any drug pre-operative | 11 |
| Total | 27 |
Baseline characteristics
| Characteristic | SSKI (Potassium Iodide) | NO SSKI | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 9 Participants | 23 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Not reported | 6 Participants | 5 Participants | 11 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White Non-Hispanic | 8 Participants | 3 Participants | 11 Participants |
| Region of Enrollment United States | 16 participants | 11 participants | 27 participants |
| Sex: Female, Male Female | 15 Participants | 9 Participants | 24 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 11 |
| other Total, other adverse events | 0 / 16 | 0 / 11 |
| serious Total, serious adverse events | 0 / 16 | 0 / 11 |
Outcome results
Primary
Change in Vascular Flow From Baseline
Using 3D imaging software, the investigators will quantify the vascular flow in the ultrasound images and compare baseline images with the operating room (OR) images to assess if there is a difference in vascular flow between those timepoints. Vascular flow will be quantified using percent (%) surface area. This calculation will be done by a computer algorithm.
Time frame: From Baseline to Immediately Before Surgery
Population: Data was not collected and therefore cannot be analyzed.