Trial Outcomes & Findings for Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass (NCT NCT02320669)

NCT ID: NCT02320669

Last Updated: 2024-04-09

Results Overview

time on mechanical ventilation after aortic cross clamp removal

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 220 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2024-04-09

Participant Flow

Participant milestones

Measure	Triiodothyronine Active Medication - Synthetic Thyroid Hormone Triostat: Bolus of Triiodothyronine followed by infusion for 48 hours	Placebo Placebo Control Placebo: Bolus of Placebo followed by infusion for 48 hours
Overall Study STARTED	110	110
Overall Study COMPLETED	104	107
Overall Study NOT COMPLETED	6	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass

Baseline characteristics by cohort

Measure	Triostat n=110 Participants Active Medication - Synthetic Thyroid Hormone Triostat: Bolus of Triiodothyronine followed by infusion for 48 hours	Placebo n=110 Participants Placebo Control Placebo: Bolus of Placebo followed by infusion for 48 hours	Total n=220 Participants Total of all reporting groups
Age, Categorical <=18 years	110 Participants n=5 Participants	110 Participants n=7 Participants	220 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	1.4 months n=5 Participants	1.4 months n=7 Participants	1.4 months n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	41 Participants n=7 Participants	84 Participants n=5 Participants
Sex: Female, Male Male	67 Participants n=5 Participants	69 Participants n=7 Participants	136 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	71 Participants n=5 Participants	62 Participants n=7 Participants	133 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	23 Participants n=5 Participants	24 Participants n=7 Participants	47 Participants n=5 Participants
Region of Enrollment United States	110 participants n=5 Participants	110 participants n=7 Participants	220 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: modified intention to treat

time on mechanical ventilation after aortic cross clamp removal

Outcome measures

Measure	Triostat n=110 Participants Active Medication - Synthetic Thyroid Hormone Triostat: Bolus of Triiodothyronine followed by infusion for 48 hours	Placebo n=110 Participants Placebo Control Placebo: Bolus of Placebo followed by infusion for 48 hours
Time To Extubation	46.9 hours Interval 25.9 to 71.6	48.0 hours Interval 31.0 to 65.4

SECONDARY outcome

Timeframe: 30 days

Population: Children under age 5 mos undergoing cardiopulmonary bypass

Length of stay in the ICU

Outcome measures

Measure	Triostat n=110 Participants Active Medication - Synthetic Thyroid Hormone Triostat: Bolus of Triiodothyronine followed by infusion for 48 hours	Placebo n=110 Participants Placebo Control Placebo: Bolus of Placebo followed by infusion for 48 hours
ICU Length of Stay	3.5 days Interval 2.3 to 4.8	2.9 days Interval 2.4 to 3.8

Adverse Events

Triostat

Serious events: 11 serious events

Other events: 17 other events

Deaths: 6 deaths

Placebo

Serious events: 11 serious events

Other events: 20 other events

Deaths: 3 deaths

Serious adverse events

Measure	Triostat n=110 participants at risk Active Medication - Synthetic Thyroid Hormone Triostat: Bolus of Triiodothyronine followed by infusion for 48 hours	Placebo n=110 participants at risk Placebo Control Placebo: Bolus of Placebo followed by infusion for 48 hours
Cardiac disorders Sentinel	10.0% 11/110 • Number of events 11 • 30 days after receiving study medication Definitions were adopted from Pediatric Heart Network criteria	10.0% 11/110 • Number of events 11 • 30 days after receiving study medication Definitions were adopted from Pediatric Heart Network criteria

Other adverse events

Measure	Triostat n=110 participants at risk Active Medication - Synthetic Thyroid Hormone Triostat: Bolus of Triiodothyronine followed by infusion for 48 hours	Placebo n=110 participants at risk Placebo Control Placebo: Bolus of Placebo followed by infusion for 48 hours
Cardiac disorders Cardiac Arrhythmia	15.5% 17/110 • Number of events 110 • 30 days after receiving study medication Definitions were adopted from Pediatric Heart Network criteria	18.2% 20/110 • Number of events 110 • 30 days after receiving study medication Definitions were adopted from Pediatric Heart Network criteria

Additional Information

Michael A Portman

Seattle Childrens hospital

Phone: 206-987-1014

Email: michael.portman@seattlechildrens.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place