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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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ClinicalTrials.gov Identifier: NCT02222532
Recruitment Status : Completed
First Posted : August 21, 2014
Last Update Posted : February 17, 2016
Sponsor:
Collaborators:
CRDF Global
Osypka Germany
Dalim BioTech Co., Ltd.
Information provided by (Responsible Party):
Eva M Marwali,MD, National Cardiovascular Center Harapan Kita Hospital Indonesia

Brief Summary:
Infants and children undergoing cardiac surgery require mechanical support for circulation called cardiopulmonary bypass. The artificial pump ensures that blood flow to the body is maintained during surgical procedure on the heart. However, the pump circulation disrupts regulation of thyroid hormone. This hormone is a critical regulator of heart and circulatory function. Deficiencies in thyroid hormone adversely affect recovery of the heart after cardiac surgery. A recent study by the principal investigator showed that supplementing patients younger than 5 months old shortened the time spent on the ventilator (breathing machine) after surgery. Populations undergoing heart surgery in developing countries such as Indonesia are different than those in the U.S. and other industrial nations. For many heart defects children undergo surgery at an older age. They are then sicker for longer periods, and are often malnourished. These older malnourished children have lower thyroid hormone levels even prior to surgery, and show dramatic further drops after surgery. Shortening time on the ventilator should improve their recovery, and also improve overall availability of resources in developing countries. The formulation of thyroid hormone provided in the U.S and given intravenous is relatively expensive. However, a much more inexpensive formulation is available in Indonesia, which can be given through a tube extending from the nose to the stomach. We propose testing this formulation made in Korea, known as Tetronine, in two vulnerable populations in Indonesia: children younger than 5 months of age, and those older than 5 months who are malnourished. All these patients will be undergoing cardiopulmonary bypass for congenital heart defects. This project will be an important collaboration between U.S and Indonesian investigators. If successful, it will have a general positive impact on care of the entire population of young children undergoing cardiac surgery in developing countries by reducing time on the ventilator and improving access to care.

Condition or disease Intervention/treatment Phase
Postoperative; Dysfunction Following Cardiac Surgery Drug: Tetronine Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tetronine (Sodium Liothyronine) for Infants & Children Undergoing Cardiopulmonary Bypass in a Middle Income Nation (OTICC Study)
Study Start Date : June 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tetronine
Oral T3 (Tetronine) is given 1 mcg/kg every 6 hourly through naso-gastric tube since induction of anesthesia for 60 hours
Drug: Tetronine
Oral T3 was given 1 microgram/kgBW q6h since induction of anesthesia for 11 doses (for 60 hours)
Other Name: Oral Triidothyronine (T3)

Placebo Comparator: Placebo
Placebo (saccharin lactic) is given every 6 hourly through naso-gastric tube since induction of anesthesia for 60 hours
Drug: Placebo
Placebo was sacharum lactis, given q6h since induction of anesthesia for 11 doses (for 60 hours)
Other Name: Saccharin Lactic




Primary Outcome Measures :
  1. Intubation time [ Time Frame: Up to 7 days post surgery ]
    All patients after undergoing congenital heart surgery will be supported by mechanical ventilation. Duration of this support on mechanical ventilation after surgery will be assessed in the treatment group and placebo group. Thyroid supplementation will increase the cardiac function and will make the patients extubated early than the patients without supplementation.


Secondary Outcome Measures :
  1. Inotropic score and vasoactive-inotropic score [ Time Frame: 1, 6, 12, 18, 24, 36, 48, 60 and 72 hours post Cross clamp removal ]
    The amount of inotropic drugs are calculated and reviewed serially since cross clamp removal until all drugs are stopped.


Other Outcome Measures:
  1. Fluid balance [ Time Frame: Until day 3 ]
    Fluid balances include amount of diuresis, chest drain production, peritoneal dialysis, and the use of diuretics.

  2. Hemodynamic parameter [ Time Frame: Every hourly until 12 hours post Cross clamp removal, every 3 hours until 24 hours, every 6 hours until 48 hours and every 12 hours until 72 hours post cross clamp removal, ]
    Hemodynamic parameter such blood pressure, heart rate, heart rhythm, and body temperature

  3. Low cardiac output syndrome [ Time Frame: 6 hours, 12 hours, 18 hours, 24 hours and 48 hours post aortic cross clamp removal ]
    Low cardiac output in which clinical sign and symptoms of low cardiac output are found with or without the increasing of arterial and venous saturation gap and metabolic acidosis and the condition needs 100% inotropic support or even more than that from the beginning of inotropic used, the use of new inotropic, mechanical support, or other maneuvers in order to increase cardiac output (e.g pacemaker)

  4. Ejection fraction [ Time Frame: Day 1, 2 and 3 after surgery ]
    Ejection fraction is measured by Echocardiography

  5. Cardiac output [ Time Frame: Day 1, 2 and 3 post surgery ]
    Cardiac output is measured by echocardiography

  6. Systemic vascular resistance index (SVRI) [ Time Frame: Day 1, 2 and 3 after surgery ]
    SVRI is measured by echocardiography



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Ages Eligible for Study:   up to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02222532


Locations
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Indonesia
Pediatric Cardiac ICU National Cardiovascular Center Harapan Kita
Jakarta, DKI Jakarta, Indonesia, 11420
Sponsors and Collaborators
National Cardiovascular Center Harapan Kita Hospital Indonesia
CRDF Global
Osypka Germany
Dalim BioTech Co., Ltd.
Investigators
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Principal Investigator: Eva M Marwali, MD National Cardiovascular Center Harapan Kita Jakarta
Study Chair: Michael A Portman, MD University of Washington
Publications:
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Responsible Party: Eva M Marwali,MD, MD, National Cardiovascular Center Harapan Kita Hospital Indonesia
ClinicalTrials.gov Identifier: NCT02222532    
Other Study ID Numbers: GITX-14-60143-0
First Posted: August 21, 2014    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Keywords provided by Eva M Marwali,MD, National Cardiovascular Center Harapan Kita Hospital Indonesia:
tetronine
congenital heart disease
cardiopulmonary bypass
euthyroid sick syndrome