Abstract

Background: In Indonesia, children with congenital heart disease (CHD) usually present later for corrective surgery than in developed countries. These children show chronic malnutrition associated with low thyroid hormone levels, which decline further immediately after open-heart surgery. Objectives: To test the hypothesis that oral triiodothyronine (T3) supplementation improves clinical outcome indexed by time to extubation (TTE) after aortic cross-clamp release. Methods: The study was a single center, randomized, double blind, and placebo controlled trial in children with CHD younger than 2 years of age undergoing open-heart surgery. Oral T3 or placebo was administered every 6 hours for 60 hours. TTE served as the primary endpoint. Hemodynamics, echocardiography parameters, inotropic score, fluid balance, diuresis, and sepsis complication were serially recorded and evaluated as secondary endpoints Results: A total of 78 patients were allocated to T3 group and 74 patients to the control group. Oral T3 prevented the declination in serum T3 noted in control group. The T3 group had a shorter time to extubation than placebo with a mean (SD) 25.99(24.30) and 40.71(56.29) hours, respectively and a hazard ratio for chance of extubation (95% CI) 1.49 (1.06-2.11), p=0.02. The median (IQ) cardiac index increased significantly after surgery in T3 (day 1 vs. day 2, 3.28 (2.46 - 4.46) to. 3.65 (2.65 - 4.77) L/min/m2, p=0.01), but not in the placebo group. More diuresis and a significantly more negative fluid balance (p=0.03) were found in T3 group during the first 72 hours post surgery. No difference in the use of inotropic agents or loop diuretics. Sepsis was significantly lower in T3 group with incidence (%) of sepsis in T3 and placebo group 1(1) vs. 10(13) patients, (p=0.004), respectively. Otherwise there was no difference in adverse events including arrhythmia. Conclusion: Oral T3 supplementation is safe and provides multiple clinical benefits in an extremely vulnerable population of children in a developing country. Any reduction in TTE could improve sparse resources by increasing ventilator and ICU availability.

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