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

Primary Purpose

Graves Disease, Hyperthyroidism

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Potassium Iodide
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Graves Disease focused on measuring Graves Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UMASS Memorial Health Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Potassium Iodide

No Treatment

Arm Description

8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation.

The experimental group receives no treatment.

Outcomes

Primary Outcome Measures

Blood Loss During Surgery
Blood loss in milliliters during surgery.

Secondary Outcome Measures

Full Information

First Posted
July 22, 2009
Last Updated
November 10, 2015
Sponsor
University of Massachusetts, Worcester
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1. Study Identification

Unique Protocol Identification Number
NCT00946296
Brief Title
Impact of SSKI Pre-Treatment on Blood Loss in Thyroidectomy for Graves Disease
Official Title
Impact of SSKI Pre-Treatment on Blood Loss in Thyroidectomy for Graves Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Massachusetts, Worcester

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graves Disease, Hyperthyroidism
Keywords
Graves Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Potassium Iodide
Arm Type
Active Comparator
Arm Description
8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation.
Arm Title
No Treatment
Arm Type
No Intervention
Arm Description
The experimental group receives no treatment.
Intervention Type
Drug
Intervention Name(s)
Potassium Iodide
Other Intervention Name(s)
SSKI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood Loss During Surgery
Description
Blood loss in milliliters during surgery.
Time Frame
up to 162 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
UMASS Memorial Health Care
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States

12. IPD Sharing Statement

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

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