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

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ClinicalTrials.gov Identifier: NCT04080505
Recruitment Status : Recruiting
First Posted : September 6, 2019
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Jennifer Kuo, 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).

Condition or disease Intervention/treatment Phase
Graves Disease Drug: SSKI- Potassium Iodide Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: None (Open Label)
Primary Purpose: Other
Official Title: Does the Use of Pre-operative SSKI Actually Reduce Vascularity and Improve Surgical Outcomes for Total Thyroidectomy in Graves' Disease?
Actual Study Start Date : February 10, 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arm Intervention/treatment
Active Comparator: SSKI (Potassium Iodide)
Participants randomized to receive 7 days of pre-operative SSKI
Drug: SSKI- Potassium Iodide
1g/mL, 2 drops orally 3 times a day for 7 days before surgery

No Intervention: NO SSKI
Participants randomized to not receive any drug pre-operative



Primary Outcome Measures :
  1. Change in Vascular Flow from Baseline [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • no Graves' disease
  • < 18 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04080505


Contacts
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Contact: Jennifer Kuo, MD 212-305-6969 jhk2029@cumc.columbia.edu
Contact: Vilma Rosario 212-305-6033 vr2222@cumc.columbia.edu

Locations
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United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Jennifer Kuo, MD    212-305-6969    jhk2029@cumc.columbia.edu   
Contact: Vilma Rosario    212-305-6033    vr2222@columbia.edu   
Principal Investigator: Jennifer Kuo, MD         
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Jennifer Kuo, MD Columbia University Irving Medical Center

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Responsible Party: Jennifer Kuo, Assistant Professor of Surgery, Columbia University
ClinicalTrials.gov Identifier: NCT04080505     History of Changes
Other Study ID Numbers: AAAO3312
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Graves Disease
Orbital Diseases
Eye Diseases
Thyroid Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Exophthalmos
Goiter
Hyperthyroidism
Iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs