Impact of SSKI Pre-Treatment on Blood Loss in Thyroidectomy for Graves Disease

Graves Disease Clinical Trial

Official title:

Impact of SSKI Pre-Treatment on Blood Loss in Thyroidectomy for Graves Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00946296
• Other study ID #: 11597
• Status: Completed
• Phase: Phase 4
• First received: July 22, 2009
• Last updated: November 10, 2015
• Start date: April 2005
• Est. completion date: April 2013

Study information

• Verified date: November 2015
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether a brief course of SSKI (saturated solution of potassium iodide) administered preoperatively provides any benefit in the surgical management of patients undergoing thyroidectomy as definitive management of their Graves Disease.

Description:

Historically Potassium Iodide was given to patients for 1 week prior to thyroidectomy. This common practice was used to decrease thyroid function and prevent thyroid storm during the thyroidectomy. However, in modern practice, nearly all patients presenting for surgical management have been made euthyroid through the use of medications such as propylthiouracil. Despite this potassium iodine continues to be administered with the presumption that it decreases the friability of the gland making surgery easier, with less blood loss.

The outcomes to be measured in this surgery are operative time, operative complications and blood loss.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients with a clinical diagnosis of Graves Disease

• Patients who have selected surgical resection as treatment of their Graves Disease

• Prior use of anti thyroid medication so that patient is clinically and biochemically euthyroid

Exclusion Criteria:

• Patients deemed unfit for surgery by operating surgeon or anesthesist

• Patients who are clinically hyperthyroid or have T3 or T4 levels 2X the upper limit of normal

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Graves Disease
• Hyperthyroidism

Intervention

Drug:
• Potassium Iodide
8 drops of Potassium Iodide in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care.

Locations

Country	Name	City	State
United States	UMASS Memorial Health Care	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Loss During Surgery	Blood loss in milliliters during surgery.	up to 162 minutes	Yes