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TRICC-2: Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass

Sponsor
Seattle Children's Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02320669
Collaborator
(none)
220
Enrollment
3
Locations
2
Arms
59
Duration (Months)
73.3
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
220 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass
Study Start Date :
Nov 1, 2014
Anticipated Primary Completion Date :
Oct 1, 2019
Anticipated Study Completion Date :
Oct 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Triostat

Active Medication - Synthetic Thyroid Hormone

Drug: Triostat
Bolus of Triiodothyronine followed by infusion for 48 hours
Other Names:
  • triiodothyronine

    		•
    Placebo Comparator: Placebo

    Placebo Control

    Drug: Placebo
    Bolus of Placebo followed by infusion for 48 hours

    Outcome Measures

    Primary Outcome Measures

    1. Time To Extubation [30 days]

    Secondary Outcome Measures

    1. ICU Length of Stay [30 days]

      Length of stay in the ICU

    2. Discharge on Oral Feeds [30 days]

      Whether or not patient is discharged on oral feeding

    3. Mortality [30 days]

      Mortality (if applicable)

    4. Duration of freedom from Extracorporeal Membrane Oxygenation (ECMO) - if applicable [30 days]

      start of ECMO (if applicable) meets this secondary endpoint, indicates significant patient regression for inpatient status post-operatively.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 5 Months
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Los Angeles Children's Hospital Los Angeles California United States 90027
    2 Lucille Packard Children's Hospital Palo Alto California United States 94304
    3 Seattle Children's Hospital Seattle Washington United States 98105

    Sponsors and Collaborators

    • Seattle Children's Hospital

    Investigators

    • Principal Investigator: Michael Portman, MD, Seattle Children's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Michael Portman, Principal Investigator, Seattle Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT02320669
    Other Study ID Numbers:
    • 14798
    • R01FD004362-01A2
    First Posted:
    Dec 19, 2014
    Last Update Posted:
    Jul 19, 2018
    Last Verified:
    Jul 1, 2018
    Additional relevant MeSH terms:
    Heart Defects, Congenital

    Study Results

    No Results Posted as of Jul 19, 2018