Non-thyroidal Illness SyndromeNCT01153360
Peri-operative Oral Triiodothyronine Replacement Therapy to Decrease the Risk of Transient Atrial Fibrillation After Off-pump Coronary Artery Bypass Surgery
A study testing liothyronine sodium in people with Non-thyroidal Illness Syndrome, run by Yonsei University at 1 site in South Korea.
Trial summary
This study is planned to medicate oral T3(Liothyronine)to the patients who are planned to have OPCAB(off- pump coronary bypass graft surgery. The aim of this study was to assess the effects of oral triiodothyronine (T3) therapy on postoperative thyroid hormone concentrations, hemodynamic variables and outcomes in… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Non-thyroidal Illness Syndrome
- What is being tested?
- liothyronine sodium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2010to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are undergoing Off-pump coronary artery bypass graft
Who cannot join
- No normal sinus rhythm,
- History of thyroid disease
- Abnormal thyroid hormone
- Renal dysfunction
- Hepatic dysfunction
- LVEF <30%
- Recent MI
- Active infection 1~15
Trial locations and contacts
1 site in 1 country.
About this study
This study is planned to medicate oral T3(Liothyronine)to the patients who are planned to have OPCAB(off- pump coronary bypass graft surgery. The aim of this study was to assess the effects of oral triiodothyronine (T3) therapy on postoperative thyroid hormone concentrations, hemodynamic variables and outcomes in patients undergoing OPCAB in a randomized, controlled trial.
- Conditions
- Non-thyroidal Illness Syndrome
- Being tested
- liothyronine sodium, placebo
- Medical subject headings
- Euthyroid Sick Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liothyronine sodiumDrug
liothyronine sodium 20ug, every 12hour (before anesthetic induction, total 4 times)
placeboDrug
vitamin B12
| Study group | Role | What they receive |
|---|---|---|
| T3 | Experimental | triiodothyronine Receives: Drug: liothyronine sodium |
| cyanocobalamin | Active comparator | vitamin B12 Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the serum T3 concentrations and the number of patients with serum T3 concentrations below the normal range between the groups
Measured: until 36 hours after surgery
Secondary outcomes (1)
difference of hemodynamic performance and myocardial injury
difference of hemodynamic performance and myocardial injury between the groups
Measured: during surgery and 36 hr after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-thyroidal Illness SyndromeStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong-Sun Choi, Yonsei University
- Investigators
- Yong-Sun Choi, MD, Ph.D, Principal investigator, Anesthesiology & Pain Medicine, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01153360
- Sponsor's protocol ID
- 4-2010-0086
- Status last verified
- Jul 2012
- First submitted
- 29 Jun 2010
- Last updated
- 24 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-operative Oral Triiodothyronine Replacement Therapy to Decrease the Risk of Transient Atrial Fibrillation After Off-pump Coronary Artery Bypass Surgery
- ClinicalTrials.gov ID
- NCT01153360
- Acronym / sponsor ID
- 4-2010-0086
- Conditions
- Non-thyroidal Illness Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 30 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is planned to medicate oral T3(Liothyronine)to the patients who are planned to have OPCAB(off- pump coronary bypass graft surgery. The aim of this study was to assess the effects of oral triiodothyronine (T3) therapy on postoperative thyroid hormone concentrations, hemodynamic variables and outcomes in patients undergoing OPCAB in a randomized, controlled trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T3 | Experimental | Drug: liothyronine sodiumtriiodothyronine |
| cyanocobalamin | Active comparator | Drug: placebovitamin B12 |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are undergoing Off-pump coronary artery bypass graft
Key exclusion criteria (8 listed)
- No normal sinus rhythm,
- History of thyroid disease
- Abnormal thyroid hormone
- Renal dysfunction
- Hepatic dysfunction
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 |
|---|---|---|
| liothyronine sodiumliothyronine sodium 20ug, every 12hour (before anesthetic induction, total 4 times) | Drug | T3 |
| placebovitamin B12 | Drug | cyanocobalamin |
Primary outcome
compare the serum T3 concentrations and the number of patients with serum T3 concentrations below the normal range between the groups
Time frame: until 36 hours after surgery
1 secondary outcome
difference of hemodynamic performance and myocardial injury
Time frame: during surgery and 36 hr after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2012.
Related trials for Non-thyroidal Illness Syndrome
RecruitingObservational study
Factors Influencing Outcomes in ECMO and Impella Patients: Metabolic and Thyroid Hormone Dynamics
Cardiogenic Shock, Euthyroid Sick Syndrome
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.
Yong-Sun Choi, MD, Ph.D principal investigator
Anesthesiology & Pain Medicine, Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing liothyronine sodium in people with Non-thyroidal Illness Syndrome, run by Yonsei University at 1 site in South Korea.
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 1 inclusion and 8 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 24 Jul 2012. 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 South Korea. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
compare the serum T3 concentrations and the number of patients with serum T3 concentrations below the normal range between the groups (time frame: until 36 hours after surgery). 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 24 Jul 2012.