Graves DiseasePhase 4NCT00946296
Impact of SSKI Pre-Treatment on Blood Loss in Thyroidectomy for Graves Disease
A Phase 4 study testing Potassium Iodide in people with Graves Disease and Hyperthyroidism, run by University of Massachusetts, Worcester at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graves Disease, Hyperthyroidism
- What is being tested?
- Potassium Iodide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Apr 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UMASS Memorial Health Care
Worcester, Massachusetts, 01655
About this study
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.
Read the 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.
- Conditions
- Graves Disease, Hyperthyroidism
- Being tested
- Potassium Iodide
- Keywords
- Graves Disease
- Medical subject headings
- Graves Disease, Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potassium IodideDrug
Also called SSKI
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.
| Study group | Role | What they receive |
|---|---|---|
| Potassium Iodide | Active comparator | 8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation. Receives: Drug: Potassium Iodide |
| No Treatment | No intervention | The experimental group receives no treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Loss During Surgery
Blood loss in milliliters during surgery.
Measured: up to 162 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startApr 2005
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Graves DiseaseStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00946296
- Sponsor's protocol ID
- 11597
- Status last verified
- Nov 2015
- First submitted
- 22 Jul 2009
- Last updated
- 15 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of SSKI Pre-Treatment on Blood Loss in Thyroidectomy for Graves Disease
- ClinicalTrials.gov ID
- NCT00946296
- Acronym / sponsor ID
- 11597
- Conditions
- Graves Disease, Hyperthyroidism
- Keywords
- Graves Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 24 Jul 2009 (estimated)
- Results
- Posted 15 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Potassium Iodide | Active comparator | Drug: Potassium Iodide8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation. |
| No Treatment | No intervention | –The experimental group receives no treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Potassium IodideAlso: SSKI8 drops of Potassium Iodide in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care. | Drug | Potassium Iodide |
Primary outcome
Blood Loss During Surgery
Time frame: up to 162 minutes
Blood loss in milliliters during surgery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Potassium Iodide in people with Graves Disease and Hyperthyroidism, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Loss During Surgery (time frame: up to 162 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2015.