Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass

NCT02320669 | Completed Phase 3 Results DMC

• 2 other identifiers: 14798R01FD004362-01A2
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 3

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.

Conditions

Congenital Heart Defects

Outcome Measures

Primary Outcomes (1)

• Time To Extubation

  time on mechanical ventilation after aortic cross clamp removal

  30 days

Secondary Outcomes (1)

• ICU Length of Stay

  30 days

Study Arms (2)

Triostat

EXPERIMENTAL

Active Medication - Synthetic Thyroid Hormone

Drug: Triostat

Placebo

PLACEBO COMPARATOR

Placebo Control

Drug: Placebo

Interventions

Triostat DRUG

Bolus of Triiodothyronine followed by infusion for 48 hours

Also known as: triiodothyronine

Triostat

Placebo DRUG

Bolus of Placebo followed by infusion for 48 hours

Placebo

Eligibility Criteria

• Age: Up to 5 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Informed consent obtained
• Male and female patients \<5 months (152 days) of age
• Patients undergoing cardiopulmonary bypass

You may not qualify if:

• Trisomy 13 and 18
• Prolonged preoperative ventilator support which would not be impacted by cardiac surgery (Lung disease: bronchopulmonary dysplasia, hypoplastic lungs associated with diaphragmatic hernia)
• Any other condition as determined by the PI causing prolonged ventilator support which is unlikely to respond favorably to cardiac surgery
• Prior participation in the clinical trial

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Study Sites (3)

Los Angeles Children's Hospital

Los Angeles, California, 90027, United States

Location

Lucille Packard Children's Hospital

Palo Alto, California, 94304, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (1)

• Portman MA, Slee AE, Roth SJ, Radman M, Olson AK, Mainwaring RD, Kamerkar A, Nuri M, Hastings L; TRICC Investigators. Triiodothyronine Supplementation in Infants Undergoing Cardiopulmonary Bypass: A Randomized Controlled Trial. Semin Thorac Cardiovasc Surg. 2023 Spring;35(1):105-112. doi: 10.1053/j.semtcvs.2022.01.005. Epub 2022 Jan 31.

  PMID: 35093535 RESULT

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Triiodothyronine

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Thyronines; Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Thyroxine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Michael A Portman
• Organization: Seattle Childrens hospital

michael.portman@seattlechildrens.org

206-987-1014

Study Officials

• Michael Portman, MD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: December 19, 2014
• Study Start: November 1, 2014
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: April 9, 2024
• Results First Posted: April 9, 2024

Record last verified: 2024-03

Locations

US (3)