Heart Defects, CongenitalPhase 3NCT00027417
Study of Triostat in Infants During Heart Surgery
A Phase 3 study testing Liothyronine sodium/triiodothyronine and Cardiopulmonary bypass and cardiac surgery in people with Heart Defects, Congenital, run by Michael Portman at 1 site in United States.
Trial summary
This is a study to determine the safety and efficacy of liothyronine sodium/triiodothyronine (Triostat), a synthetic thyroid hormone, when given to infants with congenital heart disease during cardiopulmonary bypass surgery. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Heart Defects, Congenital
- What is being tested?
- Liothyronine sodium/triiodothyronine and Cardiopulmonary bypass and cardiac surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 195 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2001to Aug 2007
- Phase
- Phase 3
- 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 Up to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of one of the following:
- Ventricular septal defect (VSD)
- Infant coarctation of the aorta
- Transposition of the great arteries
- Tetralogy of Fallot
- Complete atrioventricular canal defect
- Hypoplastic left heart, including patients who undergo a Norwood type procedure for aortic or mitral atresia
- Patient must be scheduled for surgery.
Who cannot join
- Certain additional defects and/or requirement for additional surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital and Regional Medical Center
Seattle, Washington, 98105
About this study
Official title: Triostat in Children During CardioPulmonary Bypass (CPB)
This is a study to determine the safety and efficacy of liothyronine sodium/triiodothyronine (Triostat), a synthetic thyroid hormone, when given to infants with congenital heart disease during cardiopulmonary bypass surgery.
Read the detailed description
Patients will be randomized to receive study drug or placebo and randomization will occur stratified to each diagnostic category. All patients undergo preoperative echocardiograms to provide preoperative cardiac function data. The study drug or placebo will be provided in the operating room as an iv bolus just prior to cardiopulmonary bypass and as a bolus delivered on release of the aortic cross-clamp. This will be followed by iv for 12 hours. Operative data will be collected including CPB time, aortic cross-clamp time, length and degree of hypothermia. These data will be extracted from the anesthesia record.
- Conditions
- Heart Defects, Congenital
- Being tested
- Liothyronine sodium/triiodothyronine, Cardiopulmonary bypass and cardiac surgery
- Keywords
- Congenital heart defects, Hypoplastic left heart syndrome, Complete atrioventricular canal defect, Triostat, Cardiac surgery
- Medical subject headings
- Heart Defects, Congenital, Hypoplastic Left Heart Syndrome, Endocardial Cushion Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liothyronine sodium/triiodothyronineDrug
Cardiopulmonary bypass and cardiac surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Liothyronine Sodium/Triiodothyronine | Active comparator | bolus administration of Liothyronine Sodium/Triiodothyronine (Triostat) immediately prior to CPB institution and after removal of aortic cross clamp, followed by repeated boluses, will be safe and will result in significant improvements in postoperative and clinical outcome parameters and cardiac contractile function. Receives: Drug: Liothyronine sodium/triiodothyronine; Procedure: Cardiopulmonary bypass and cardiac surgery |
| Placebo | Placebo comparator | bolus administration of Placebo immediately prior to CPB institution and after removal of aortic cross clamp, followed by repeated boluses Receives: Drug: Liothyronine sodium/triiodothyronine; Procedure: Cardiopulmonary bypass and cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of mechanical ventilation after cardiopulmonary bypass.
Reducing the length of ventilatory support minimizes other postoperative complications, which can contribute to morbidity.
Measured: 0 to 72 hours
Secondary outcomes (1)
Assess other parameters
- Need for mechanic circulatory support, fluid balance (intake and output); urine output
- Echocardiographic measures to include end-systolic wall stress/fractional shortening ratio
- Myocardial performance index (Doppler derived), cardiac index (Doppler derived)
- Heart rate, blood pressure and central venous pressure
- Free and total T3 levels
- Others: All medications including inotropic agents will be recorded with respect to time initiated, terminated, and dosage will be recorded for exploratory analyses.
Measured: 0 to 72 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2001 (estimated)
- Study startApr 2001
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Defects, CongenitalStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Portman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael Portman, Seattle Children's Hospital
- Investigators
- Michael Portman, MD, Principal investigator, Seattle Childrens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00027417
- Sponsor's protocol ID
- FD-R-1971-01
- Other IDs
- FD-R-001971-01
- Status last verified
- Aug 2013
- First submitted
- 5 Dec 2001
- Last updated
- 5 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Portman MA, Slee A, Olson AK, Cohen G, Karl T, Tong E, Hastings L, Patel H, Reinhartz O, Mott AR, Mainwaring R, Linam J, Danzi S; TRICC Investigators. Triiodothyronine Supplementation in Infants and Children Undergoing Cardiopulmonary Bypass (TRICC): a multicenter placebo-controlled randomized trial: age analysis. Circulation. 2010 Sep 14;122(11 Suppl):S224-33. doi: 10.1161/CIRCULATIONAHA.109.926394.
PubMed 20837917
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triostat in Children During CardioPulmonary Bypass (CPB)
- ClinicalTrials.gov ID
- NCT00027417
- Acronym / sponsor ID
- FD-R-1971-01
- Conditions
- Heart Defects, Congenital
- Keywords
- Congenital heart defects, Hypoplastic left heart syndrome, Complete atrioventricular canal defect, Triostat, Cardiac surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Michael PortmanUniversity, hospital or other
- Study start
- Apr 2001
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 7 Dec 2001 (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 is a study to determine the safety and efficacy of liothyronine sodium/triiodothyronine (Triostat), a synthetic thyroid hormone, when given to infants with congenital heart disease during cardiopulmonary bypass surgery.
Detailed description
Patients will be randomized to receive study drug or placebo and randomization will occur stratified to each diagnostic category. All patients undergo preoperative echocardiograms to provide preoperative cardiac function data. The study drug or placebo will be provided in the operating room as an iv bolus just prior to cardiopulmonary bypass and as a bolus delivered on release of the aortic cross-clamp. This will be followed by iv for 12 hours. Operative data will be collected including CPB time, aortic cross-clamp time, length and degree of hypothermia. These data will be extracted from the anesthesia record.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liothyronine Sodium/Triiodothyronine | Active comparator | Drug: Liothyronine sodium/triiodothyronine, Procedure: Cardiopulmonary bypass and cardiac surgerybolus administration of Liothyronine Sodium/Triiodothyronine (Triostat) immediately prior to CPB institution and after removal of aortic cross clamp, followed by repeated boluses, will be safe and will result in significant improvements in postoperative and clinical outcome parameters and cardiac contractile function. |
| Placebo | Placebo comparator | Drug: Liothyronine sodium/triiodothyronine, Procedure: Cardiopulmonary bypass and cardiac surgerybolus administration of Placebo immediately prior to CPB institution and after removal of aortic cross clamp, followed by repeated boluses |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Ventricular septal defect (VSD)
- Infant coarctation of the aorta
- Transposition of the great arteries
- Tetralogy of Fallot
- Complete atrioventricular canal defect
Key exclusion criteria (1 listed)
- Certain additional defects and/or requirement for additional surgery.
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 sodium/triiodothyronine | Drug | Liothyronine Sodium/Triiodothyronine, Placebo |
| Cardiopulmonary bypass and cardiac surgery | Procedure or surgery | Liothyronine Sodium/Triiodothyronine, Placebo |
Primary outcome
duration of mechanical ventilation after cardiopulmonary bypass.
Time frame: 0 to 72 hours
Reducing the length of ventilatory support minimizes other postoperative complications, which can contribute to morbidity.
1 secondary outcome
Assess other parameters
Time frame: 0 to 72 hrs
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 5 Aug 2013.
- Derived from this study: PubMed 20837917Portman MA, Slee A, Olson AK, Cohen G, Karl T, Tong E, Hastings L, Patel H, Reinhartz O, Mott AR, Mainwaring R, Linam J, Danzi S; TRICC Investigators. Triiodothyronine Supplementation in Infants and Children Undergoing Cardiopulmonary Bypass (TRICC): a multicenter placebo-controlled randomized trial: age analysis. Circulation. 2010 Sep 14;122(11 Suppl):S224-33. doi: 10.1161/CIRCULATIONAHA.109.926394.
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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.
Michael Portman, MD principal investigator
Seattle Childrens Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Liothyronine sodium/triiodothyronine and Cardiopulmonary bypass and cardiac surgery in people with Heart Defects, Congenital, run by Michael Portman 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 8 inclusion and 1 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 5 Aug 2013. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
duration of mechanical ventilation after cardiopulmonary bypass. (time frame: 0 to 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00027417, which also lists 1 linked publication.
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 5 Aug 2013.