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

• Sponsor: University of Massachusetts, Worcester (Other)
• Overall Status: Completed
• CT.gov ID: NCT00946296
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 2
• Duration (Months): 96
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Graves Disease; Hyperthyroidism	Drug: Potassium Iodide	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Impact of SSKI Pre-Treatment on Blood Loss in Thyroidectomy for Graves Disease
• Study Start Date: Apr 1, 2005
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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 Names: SSKI
No Intervention: No Treatment The experimental group receives no treatment.

Outcome Measures

Primary Outcome Measures

1. Blood Loss During Surgery [up to 162 minutes]

   Blood loss in milliliters during surgery.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	UMASS Memorial Health Care	Worcester	Massachusetts	United States	01655

Sponsors and Collaborators

• University of Massachusetts, Worcester

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Massachusetts, Worcester
• ClinicalTrials.gov Identifier: NCT00946296
• Other Study ID Numbers: 11597
• First Posted: Jul 24, 2009
• Last Update Posted: Dec 15, 2015
• Last Verified: Nov 1, 2015

• Keywords provided by University of Massachusetts, Worcester: Graves Disease
• Additional relevant MeSH terms: Graves Disease; Hyperthyroidism

Study Results

Participant Flow

Recruitment Details	Between October 2005 and April 2013, subjects who had been determined to undergo thyroidectomy for definitive management of Graves Disease, were approached for participation in the study. Recruitment occurred in the endocrine practices of the investigators.

Arm/Group Title	Potassium Iodide	No Treatment
Arm/Group Description	8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation. 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.	The experimental group receives no treatment.
Period Title: Overall Study
STARTED	21	15
COMPLETED	18	15
NOT COMPLETED	3	0

Baseline Characteristics

Arm/Group Title	Potassium Iodide	No Treatment	Total
Arm/Group Description	8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation. 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.	The experimental group receives no treatment.	Total of all reporting groups
Overall Participants	21	15	36
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.44 (12.27)	41.07 (10.62)	40.25 (11.44)
Sex: Female, Male (Count of Participants)
Female	16 76.2%	13 86.7%	29 80.6%
Male	5 23.8%	2 13.3%	7 19.4%

Outcome Measures

1. Primary Outcome

Title	Blood Loss During Surgery
Description	Blood loss in milliliters during surgery.
Time Frame	up to 162 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Potassium Iodide	No Treatment
Arm/Group Description	8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation. 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.	The experimental group receives no treatment.
Measure Participants	18	15
Mean (Standard Deviation) [mL]	61.67 (49.97)	161.67 (134.62)

Adverse Events

Time Frame	162 minutes
Adverse Event Reporting Description	During surgical procedure
Arm/Group Title	Potassium Iodide		No Treatment
Arm/Group Description	8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation. 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.		The experimental group receives no treatment.
All Cause Mortality
	Potassium Iodide		No Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Potassium Iodide		No Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Potassium Iodide		No Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/15 (0%)

Limitations/Caveats

Difficulty in enrolling subjects related to national shortages of potassium iodine which limited drug availability and contributed to delayed accrual as did decreased eligible patients and waning interest over time.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.