Congenital Heart Defects
Conditions
Brief 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. Funding Source - FDA OOPD.
Interventions
DRUGTriostat
Bolus of Triiodothyronine followed by infusion for 48 hours
DRUGPlacebo
Bolus of Placebo followed by infusion for 48 hours
Sponsors
Seattle Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 5 Months
Healthy volunteers
No
Inclusion criteria
1. Informed consent obtained 2. Male and female patients \<5 months (152 days) of age 3. Patients undergoing cardiopulmonary bypass
Exclusion criteria
1. Known thyroid disease (Down Syndrome is not an exclusion criterion unless patient has thyroid disease) 2. Trisomy 13 and 18 3. Prolonged preoperative ventilator support which would not be impacted by cardiac surgery (Lung disease: bronchopulmonary dysplasia, hypoplastic lungs associated with diaphragmatic hernia) 4. Any other condition as determined by the PI causing prolonged ventilator support which is unlikely to respond favorably to cardiac surgery 5. Prior participation in the clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time To Extubation | 30 days | time on mechanical ventilation after aortic cross clamp removal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU Length of Stay | 30 days | Length of stay in the ICU |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Triostat Active Medication - Synthetic Thyroid Hormone
Triostat: Bolus of Triiodothyronine followed by infusion for 48 hours | 110 |
| Placebo Placebo Control
Placebo: Bolus of Placebo followed by infusion for 48 hours | 110 |
| Total | 220 |
Baseline characteristics
| Characteristic | Placebo | Total | Triostat |
|---|---|---|---|
| Age, Categorical <=18 years | 110 Participants | 220 Participants | 110 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 1.4 months | 1.4 months | 1.4 months |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 16 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 7 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 9 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 24 Participants | 47 Participants | 23 Participants |
| Race (NIH/OMB) White | 62 Participants | 133 Participants | 71 Participants |
| Region of Enrollment United States | 110 participants | 220 participants | 110 participants |
| Sex: Female, Male Female | 41 Participants | 84 Participants | 43 Participants |
| Sex: Female, Male Male | 69 Participants | 136 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 110 | 3 / 110 |
| other Total, other adverse events | 17 / 110 | 20 / 110 |
| serious Total, serious adverse events | 11 / 110 | 11 / 110 |
Outcome results
Primary
Time To Extubation
time on mechanical ventilation after aortic cross clamp removal
Time frame: 30 days
Population: modified intention to treat
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Triostat | Time To Extubation | 46.9 hours |
| Placebo | Time To Extubation | 48.0 hours |
p-value: <0.0595% CI: [0.82, 1.432]Regression, Cox
Secondary
ICU Length of Stay
Length of stay in the ICU
Time frame: 30 days
Population: Children under age 5 mos undergoing cardiopulmonary bypass
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Triostat | ICU Length of Stay | 3.5 days |
| Placebo | ICU Length of Stay | 2.9 days |