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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01780584
Other study ID # LB05.01/1.4/235/2010
Secondary ID
Status Completed
Phase Phase 2
First received January 28, 2013
Last updated February 2, 2013
Start date April 2010
Est. completion date October 2010

Study information

Verified date February 2013
Source National Cardiovascular Center Harapan Kita Hospital Indonesia
Contact n/a
Is FDA regulated No
Health authority Indonesia: Ethics Committee
Study type Interventional

Clinical Trial Summary

Low triiodothyronine (T3) syndrome defines as decrease of T3 levels during critically ill. This decrease of T3 levels was observed after congenital heart surgery using cardiopulmonary bypass. Previous largest study,Triiodothyronine for Infants and Children Undergoing Cardiopulmonary bypass (TRICC) study showed T3 supplementation decreased time to extubation for infants less than 5 months undergoing cardiopulmonary bypass. Intravenous regiment was known effective in maintaining T3 levels during pediatric cardiac surgery. This drug preparation however is not commonly used in many countries due to the relatively high costs and/or the simple lack of availability. The use of oral T3 to treat postoperative low T3 levels in pediatric patients has not been reported so far, although recent adult studies showed benefit in using oral T3 after cardiac surgery. The purpose of this study was to determine if oral T3 supplementation could prevent the decline of serum T3 in children less than 2 years of age undergoing congenital heart surgery using CPB.


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Oral T3 Low dose
Comparison of different dosages of drug. Low dose group oral T3 is 0.5 mcg/kg q24h
Placebo
Comparison of different dosages of drug. In low dose group, placebo was given alternately with oral T3 every 12h with a total 3 doses for placebo and 3 doses for oral T3
Oral T3 high dose
Comparison of different dosages of drugs. Oral T3 high dose is 0.5 mcg/kg q12h

Locations

Country Name City State
Indonesia Pediatric Cardiac ICU National Cardiovascular Center Harapan Kita Jakarta Jakarta DKI Jakarta

Sponsors (1)

Lead Sponsor Collaborator
National Cardiovascular Center Harapan Kita Hospital Indonesia

Country where clinical trial is conducted

Indonesia, 

References & Publications (1)

Portman MA, Slee A, Olson AK, Cohen G, Karl T, Tong E, Hastings L, Patel H, Reinhartz O, Mott AR, Mainwaring R, Linam J, Danzi S; TRICC Investigators. Triiodothyronine Supplementation in Infants and Children Undergoing Cardiopulmonary Bypass (TRICC): a mu — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Postoperative Time to Extubation Postoperative time to extubation is length of time on ventilator. up to 3 months after surgery Yes
Other Postoperative Length of Stay in Intensive Care Unit up to 3 months after surgery Yes
Other Postoperative Hospital Length of Stay up to 3 month after surgery Yes
Primary Free T3 (FT3) Levels Free T3 levels were measured up to 36 hours after cross-clamp removal during the first 36 hours after cross clamp removal Yes
Secondary Number of Patients With Possible Side Effects of Thyroid Hormone Supplementation Particularly Suggesting Hyperthyroid Symptoms. Specific symptoms of hyperthyroidism included cardiac dysrhythmia requiring medical or electrical treatment, hypertension (mean systolic or diastolic blood pressure more than 2 standard deviation above normal for age) and hyperthermia (>37.5 degree Celsius). One patient in low dose group had hypertension directly after surgery due to unrecognized coarctation of the aorta and this patient was withdrawal from the protocol. Since the first dose of oral T3 until 7 days after surgery Yes
See also
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Completed NCT01481402 - Liothyronine and Heart Failure. The Long Term Effect of Liothyronine on Left Ventricular Ejection Fraction (LVEF) N/A