Graves Disease, Hyperthyroidism
Conditions
Keywords
Graves Disease
Brief summary
The purpose of this study is to determine whether a brief course of SSKI (saturated solution of potassium iodide) administered preoperatively provides any benefit in the surgical management of patients undergoing thyroidectomy as definitive management of their Graves Disease.
Detailed description
Historically Potassium Iodide was given to patients for 1 week prior to thyroidectomy. This common practice was used to decrease thyroid function and prevent thyroid storm during the thyroidectomy. However, in modern practice, nearly all patients presenting for surgical management have been made euthyroid through the use of medications such as propylthiouracil. Despite this potassium iodine continues to be administered with the presumption that it decreases the friability of the gland making surgery easier, with less blood loss. The outcomes to be measured in this surgery are operative time, operative complications and blood loss.
Interventions
DRUGPotassium Iodide
8 drops of Potassium Iodide in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care.
Sponsors
University of Massachusetts, Worcester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients with a clinical diagnosis of Graves Disease * Patients who have selected surgical resection as treatment of their Graves Disease * Prior use of anti thyroid medication so that patient is clinically and biochemically euthyroid
Exclusion criteria
* Patients deemed unfit for surgery by operating surgeon or anesthesist * Patients who are clinically hyperthyroid or have T3 or T4 levels 2X the upper limit of normal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Loss During Surgery | up to 162 minutes | Blood loss in milliliters during surgery. |
Countries
United States
Participant flow
Recruitment details
Between October 2005 and April 2013, subjects who had been determined to undergo thyroidectomy for definitive management of Graves Disease, were approached for participation in the study. Recruitment occurred in the endocrine practices of the investigators.
Participants by arm
| Arm | Count |
|---|---|
| Potassium Iodide 8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation.
Potassium Iodide: 8 drops of Potassium Iodide in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care. | 21 |
| No Treatment The experimental group receives no treatment. | 15 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 3 | 0 |
Baseline characteristics
| Characteristic | Potassium Iodide | No Treatment | Total |
|---|---|---|---|
| Age, Continuous | 39.44 years STANDARD_DEVIATION 12.27 | 41.07 years STANDARD_DEVIATION 10.62 | 40.25 years STANDARD_DEVIATION 11.44 |
| Sex: Female, Male Female | 16 Participants | 13 Participants | 29 Participants |
| Sex: Female, Male Male | 5 Participants | 2 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 15 |
| serious Total, serious adverse events | 0 / 21 | 0 / 15 |
Outcome results
Primary
Blood Loss During Surgery
Blood loss in milliliters during surgery.
Time frame: up to 162 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Potassium Iodide | Blood Loss During Surgery | 61.67 mL | Standard Deviation 49.97 |
| No Treatment | Blood Loss During Surgery | 161.67 mL | Standard Deviation 134.62 |