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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02320669
Recruitment Status : Unknown
Verified July 2018 by Michael Portman, Seattle Children's Hospital.
Recruitment status was:  Recruiting
First Posted : December 19, 2014
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Portman, Seattle Children's Hospital

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
Congenital Heart Defects Drug: Triostat Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 2014
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Triostat
Active Medication - Synthetic Thyroid Hormone
Drug: Triostat
Bolus of Triiodothyronine followed by infusion for 48 hours
Other Name: triiodothyronine

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




Primary Outcome Measures :
  1. Time To Extubation [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. ICU Length of Stay [ Time Frame: 30 days ]
    Length of stay in the ICU

  2. Discharge on Oral Feeds [ Time Frame: 30 days ]
    Whether or not patient is discharged on oral feeding

  3. Mortality [ Time Frame: 30 days ]
    Mortality (if applicable)

  4. Duration of freedom from Extracorporeal Membrane Oxygenation (ECMO) - if applicable [ Time Frame: 30 days ]
    start of ECMO (if applicable) meets this secondary endpoint, indicates significant patient regression for inpatient status post-operatively.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02320669


Contacts
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Contact: Michael Portman, MD 206-987-1014 michael.portman@seattlechildrens.org
Contact: Jennifer Cox, MASc 206-884-5153 Jennifer.Cox@seattlechildrens.org

Locations
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United States, California
Los Angeles Children's Hospital Recruiting
Los Angeles, California, United States, 90027
Contact: Laura Hastings, MD       LHastings@chla.usc.edu   
Principal Investigator: Laura Hastings, MD         
Lucille Packard Children's Hospital Recruiting
Palo Alto, California, United States, 94304
Contact: Stephen Roth, MD    650-725-8349    sroth@stanford.edu   
Contact: Aihua Zhu, CCRP    650-384-5917      
Principal Investigator: Stephen Roth, MD         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Jennifer A Cox, MASc    206-884-5153    Jennifer.Cox@seattlechildrens.org   
Contact: Michael A Portman, MD    206-987-1014    michael.portman@seattlechildrens.org   
Principal Investigator: Michael Portman, MD         
Sponsors and Collaborators
Seattle Children's Hospital
Investigators
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Principal Investigator: Michael Portman, MD Seattle Children's Hospital
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Responsible Party: Michael Portman, Principal Investigator, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT02320669    
Other Study ID Numbers: 14798
R01FD004362-01A2 ( U.S. FDA Grant/Contract )
First Posted: December 19, 2014    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities