Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT00946296
First received: July 22, 2009
Last updated: November 10, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention Phase
Graves Disease
Hyperthyroidism
Drug: Potassium Iodide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Impact of SSKI Pre-Treatment on Blood Loss in Thyroidectomy for Graves Disease

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • Blood Loss During Surgery [ Time Frame: up to 162 minutes ] [ Designated as safety issue: Yes ]
    Blood loss in milliliters during surgery.


Enrollment: 36
Study Start Date: April 2005
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Potassium Iodide
8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation.
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.
Other Name: SSKI
No Intervention: No Treatment
The experimental group receives no treatment.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00946296

Locations
United States, Massachusetts
UMASS Memorial Health Care
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
  More Information

Responsible Party: University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00946296     History of Changes
Other Study ID Numbers: 11597 
Study First Received: July 22, 2009
Results First Received: October 9, 2015
Last Updated: November 10, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Massachusetts, Worcester:
Graves Disease

Additional relevant MeSH terms:
Graves Disease
Hyperthyroidism
Exophthalmos
Orbital Diseases
Eye Diseases
Goiter
Thyroid Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 09, 2016