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

NCT04080505 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: AAAO3312
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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).

Conditions

Graves Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  From Baseline to Immediately Before Surgery

Study Arms (2)

SSKI (Potassium Iodide)

ACTIVE COMPARATOR

Participants randomized to receive 7 days of pre-operative SSKI

Drug: SSKI- Potassium Iodide

NO SSKI

NO INTERVENTION

Participants randomized to not receive any drug pre-operative

Interventions

SSKI- Potassium Iodide DRUG

1g/mL, 2 drops orally 3 times a day for 7 days before surgery

SSKI (Potassium Iodide)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• no Graves' disease
• \< 18 years old

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Graves Disease

Interventions

Potassium Iodide

Condition Hierarchy (Ancestors)

Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Iodides; Iodine Compounds; Inorganic Chemicals; Potassium Compounds

Results Point of Contact

• Title: Jennifer Kuo, MD
• Organization: Columbia University

jhk2029@cumc.columbia.edu

212-305-6969

Study Officials

• Jennifer Kuo, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Model Details: 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.

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 6, 2019
• Study Start: February 10, 2015
• Primary Completion: March 3, 2023
• Study Completion: March 3, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Locations

US (1)