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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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14 March 2016 |
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Main ID: |
NCT02222532 |
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Date of registration:
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18/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Oral Triiodothyronine for Infants Less Than 5 Months & Malnourished Children Undergoing Cardiopulmonary Bypass in Indonesia
I-TRICC |
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Scientific title:
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Tetronine (Sodium Liothyronine) for Infants & Children Undergoing Cardiopulmonary Bypass in a Middle Income Nation (OTICC Study) |
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Date of first enrolment:
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June 2013 |
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Target sample size:
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224 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02222532 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Indonesia
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Contacts
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Name:
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Michael A Portman, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Washington |
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Name:
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Eva M Marwali, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Cardiovascular Center Harapan Kita Jakarta |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Children undergoing cardiopulmonary bypass
- Age 3 years old or less
- Aristotle score 6 and above
- Total correction or biventricular repair
Exclusion Criteria:
- Single ventricle defects
- Body weight less than 2 kg at the time of recruitment
- Presentation with sepsis
- Tachyarrhythmia or any other arrhythmia before surgery
- Creatinine level of more than 2 mg/dL
- Known thyroid disease
- Known lung abnormalities (incl. infection) before surgery.
Age minimum:
N/A
Age maximum:
36 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Postoperative; Dysfunction Following Cardiac Surgery
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Intervention(s)
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Drug: Tetronine
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Drug: Placebo
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Primary Outcome(s)
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Intubation time
[Time Frame: Up to 7 days post surgery]
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Secondary Outcome(s)
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Inotropic score and vasoactive-inotropic score
[Time Frame: 1, 6, 12, 18, 24, 36, 48, 60 and 72 hours post Cross clamp removal]
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Secondary ID(s)
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GITX-14-60143-0
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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