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

Phase 3

Completed

• Conditions: Graves Disease
• Interventions: Drug: SSKI- Potassium Iodide

• Registration Number: NCT04080505
• Lead Sponsor: Columbia University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-02-10
• Study First Submitted: 2019-09-04
• Study First Submitted QC: 2019-09-04
• Study First Posted: 2019-09-06
• Primary Completion: 2023-03-03
• Study Completion: 2023-03-03
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

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

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Exclusion Criteria

• no Graves' disease
• < 18 years old

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SSKI (Potassium Iodide)	SSKI- Potassium Iodide	Participants randomized to receive 7 days of pre-operative SSKI

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States