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Oral Triiodothyronine for Children Undergoing Cardiopulmonary Bypass in Indonesia

NCT02521168 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2016-02-17

No results posted yet for this study

Summary

A condition of decreased serum T3 level in children after cardiac surgery using cardiopulmonary bypass has been commonly recognized as euthyroid sick syndrome (ESS). This syndrome has been closely associated with low cardiac output syndrome after heart surgery. The unique characteristics of pediatric patients with congenital heart disease (CHD) in Indonesia have caused ESS to arise in the population even before surgical managements. Thyroid hormones increase cardiac function, respiration and diuresis. Increased myocardial function occurred through the improvement of mitochondrial effectiveness as the body energy source by utilizing effective energy substrates, lactate and pyruvate. Prevention of decreased serum thyroid hormones level by T3 supplementation could be clinically beneficial. Intravenous T3 unit dose is very expensive and inapplicable for daily use. In adult studies, oral T3 was found to be effective for the prevention of decreased serum T3 levels; similar study on pediatric population, however, has not been elucidated.

Conditions

  • Postoperative; Dysfunction Following Cardiac Surgery

Interventions

DRUG

Oral triiodothyronine

Oral triiodothyronine is given peri-operatively through naso-gastric tube

DRUG

Placebo

Placebo consist of saccharin lactis that has the same appearance as Tetronine

Sponsors & Collaborators

  • CRDF Global

    collaborator OTHER

  • Osypka Germany

    collaborator UNKNOWN

  • Dalim BioTech Co., Ltd.

    collaborator INDUSTRY

  • National Cardiovascular Center Harapan Kita Hospital Indonesia

    lead OTHER

Principal Investigators

  • Eva M Marwali, MD, PhD · National Cardiovascular Center Harapan Kita Jakarta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
36 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-10-31
Completion
2015-01-31

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02521168 on ClinicalTrials.gov