Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| FD-R-001971-01 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Placebo | Placebo Comparator | bolus administration of Placebo immediately prior to CPB institution and after removal of aortic cross clamp, followed by repeated boluses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liothyronine sodium/triiodothyronine | Drug |
| ||
| Cardiopulmonary bypass and cardiac surgery |
| Measure | Description | Time Frame |
|---|---|---|
| duration of mechanical ventilation after cardiopulmonary bypass. | Reducing the length of ventilatory support minimizes other postoperative complications, which can contribute to morbidity. | 0 to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Assess other parameters |
|
Not provided
Inclusion criteria:
Diagnosis of one of the following:
Patient must be scheduled for surgery.
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Portman, MD | Seattle Childrens Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital and Regional Medical Center | Seattle | Washington | 98105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20837917 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018636 | Hypoplastic Left Heart Syndrome |
| D004694 | Endocardial Cushion Defects |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| D014284 | Triiodothyronine |
| D002315 | Cardiopulmonary Bypass |
| D006348 | Cardiac Surgical Procedures |
| ID | Term |
|---|---|
| D013970 | Thyronines |
| D013963 | Thyroid Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Procedure |
|
| 0 to 72 hrs |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006343 | Heart Septal Defects |
| D013974 | Thyroxine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
| D013504 | Cardiovascular Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |