Overview

This trial is active, not recruiting.

Conditions graves disease, hyperthyroidism
Treatment potassium iodine
Phase phase 4
Sponsor University of Massachusetts, Worcester
Start date April 2005
End date April 2015
Trial size 35 participants
Trial identifier NCT00946296, 11597

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Active Comparator)
Receives Potassium Iodine which is the current Standard of Care
potassium iodine
8 drops of Potassium Iodine in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care. The Experimental Group is the group which receives no Potassium Iodine.
(Experimental)
potassium iodine
8 drops of Potassium Iodine in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care. The Experimental Group is the group which receives no Potassium Iodine.

Primary Outcomes

Measure
Blood Loss during surgery
time frame: Post Operatively

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Impact of SSKI Pre-Treatment on Blood Loss in Thyroidectomy for 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by University of Massachusetts, Worcester.