Does Potassium Iodide (SSKI) Reduce Vascularity in Graves' Thyroidectomy?

Columbia University

Status and phase: Terminated; Phase 3

Conditions: Graves Disease

Treatments: Drug: SSKI- Potassium Iodide

Study type: Interventional

Funder types: Other

Identifiers

NCT04080505

AAAO3312

Details and patient eligibility

About

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).

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• individuals diagnosed with Graves' disease undergoing total thyroidectomy for cure of disease.

Exclusion criteria

• no Graves' disease
• < 18 years old

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

SSKI (Potassium Iodide)

Active Comparator group

Description:

Participants randomized to receive 7 days of pre-operative SSKI

Treatment:

Drug: SSKI- Potassium Iodide

NO SSKI

No Intervention group

Description:

Participants randomized to not receive any drug pre-operative