Oral Triiodothyronine for Children Undergoing Cardiopulmonary Bypass in Indonesia

NCT02521168 | Completed Phase 3 DMC

• 1 other identifier: 164/H2.F1/ETIK/2013
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

euthyroid sick syndrome; cardiopulmonary bypass; congenital heart disease; time to extubation

Outcome Measures

Primary Outcomes (1)

• Intubation time

  All patients after undergoing congenital heart surgery will be supported by mechanical ventilation. Duration of this support since cross clamp off removal until after surgery will be assessed in the treatment and placebo group. Thyroid supplementation will increase the cardiac function and will make the patients extubated early than the patients without supplementation

  Until patients extubated after surgery in ICU OR died OR still intubated within 7 days

Secondary Outcomes (2)

• Number of patients with low cardiac output syndrome

  6 hours, 12 hours, 18 hours, 24 hours, 48 hours post aortic cross clamp removal

• Drug adverse reaction

  Every hourly until 12 hours post cross clamp removal, every 3 hours until 24 hours, every 6 hours until 48 hours, every 12 hours until 72 hours post cross clamp removal, and until the patients discharge from hospital

Other Outcomes (9)

• Inotropic and vasoactive-inotropic score

  1, 6, 12, 18, 24, 36, 48, 60 and 72 hours post cross clamp removal

• Diuresis

  From day 1 until day 3 post surgery

• Fluid balance

  From day 1until day 3 post surgery

Study Arms (2)

Oral triiodothyronine

EXPERIMENTAL

Oral T3 (triiodothyronine) is given 1 mcg/kg every 6 hourly through naso-gastric tube since induction of anaesthesia for 60 hours

Drug: Oral triiodothyronine

Placebo

PLACEBO COMPARATOR

Placebo (saccharin lactic) is given every 6 hourly through naso-gastric tube since induction of anaesthesia for 60 hours

Drug: Placebo

Interventions

Oral triiodothyronine DRUG

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

Also known as: Tetronine, Lyothyronine

Oral triiodothyronine

Placebo DRUG

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

Also known as: Saccharin lactis

Placebo

Eligibility Criteria

• Age: 1 Day - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children undergoing cardiopulmonary bypass
• Age 36 months old or less
• Aristotle score 6-9
• Total correction or biventricular repair

You may not qualify if:

• 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 (including infection) before surgery

Sponsors & Collaborators

• National Cardiovascular Center Harapan Kita Hospital Indonesia: lead
• CRDF Global: collaborator
• Osypka Germany: collaborator
• Dalim BioTech Co., Ltd.: collaborator

Study Sites (1)

Pediatric Cardiac ICU National Cardiovascular Center Harapan Kita

Jakarta, DKI Jakarta, 11420, Indonesia

Location

MeSH Terms

Conditions

Euthyroid Sick Syndromes; Heart Defects, Congenital

Interventions

Triiodothyronine

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases; 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

Study Officials

• Eva M Marwali, MD, PhD

  National Cardiovascular Center Harapan Kita Jakarta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 2, 2015
• First Posted: August 13, 2015
• Study Start: July 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: January 1, 2015
• Last Updated: February 17, 2016

Record last verified: 2016-02

Locations

ID (1)