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Trial Outcomes & Findings for Does Potassium Iodide (SSKI) Reduce Vascularity in Graves' Thyroidectomy? (NCT NCT04080505)

NCT ID: NCT04080505

Last Updated: 2024-09-19

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

29 participants

Primary outcome timeframe

From Baseline to Immediately Before Surgery

Results posted on

2024-09-19

Participant Flow

2 participants withdrew from the study prior to randomization.

Participant milestones

Participant milestones
Measure
SSKI (Potassium Iodide)
Participants randomized to receive 7 days of pre-operative SSKI SSKI- Potassium Iodide: 1g/mL, 2 drops orally 3 times a day for 7 days before surgery
No SSKI
Participants randomized to not receive any drug pre-operative
Overall Study
STARTED
16
11
Overall Study
COMPLETED
16
11
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
SSKI (Potassium Iodide)
n=16 Participants
Participants randomized to receive 7 days of pre-operative SSKI SSKI- Potassium Iodide: 1g/mL, 2 drops orally 3 times a day for 7 days before surgery
NO SSKI
n=11 Participants
Participants randomized to not receive any drug pre-operative
Total
n=27 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
14 Participants
n=5 Participants
9 Participants
n=7 Participants
23 Participants
n=5 Participants
Age, Categorical
>=65 years
2 Participants
n=5 Participants
2 Participants
n=7 Participants
4 Participants
n=5 Participants
Sex: Female, Male
Female
15 Participants
n=5 Participants
9 Participants
n=7 Participants
24 Participants
n=5 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants
2 Participants
n=7 Participants
3 Participants
n=5 Participants
Race/Ethnicity, Customized
White Non-Hispanic
8 Participants
n=5 Participants
3 Participants
n=7 Participants
11 Participants
n=5 Participants
Race/Ethnicity, Customized
Black or African American
2 Participants
n=5 Participants
2 Participants
n=7 Participants
4 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race/Ethnicity, Customized
Hispanic or Latino
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Other
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race/Ethnicity, Customized
Not reported
6 Participants
n=5 Participants
5 Participants
n=7 Participants
11 Participants
n=5 Participants
Region of Enrollment
United States
16 participants
n=5 Participants
11 participants
n=7 Participants
27 participants
n=5 Participants

PRIMARY outcome

Timeframe: From Baseline to Immediately Before Surgery

Population: Data was not collected and therefore cannot be analyzed.

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.

Outcome measures

Outcome data not reported

Adverse Events

SSKI (Potassium Iodide)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

No SSKI

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jennifer Kuo, MD

Columbia University

Phone: 212-305-6969

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place