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Indonesian Study: Triiodothyronine for Infants Less than 5 Months Undergoing Cardiopulmonary Bypass
Eva Miranda Marwali1,2,3, Albert Lopolisa4, Alvin A Sani4
1Pediatric Cardiac Intensive Care Unit, National Cardiovascular Center Harapan Kita, Jakarta, Indonesia. eva.marwali@pjnhk.go.id.
Insights
Oral triiodothyronine (T3) supplementation in infants undergoing heart surgery in Indonesia improved outcomes, reducing low cardiac output syndrome. T3 significantly shortened extubation time in low-risk patients, suggesting its potential benefit in high-risk emerging programs.
Area of Science:
- Cardiology
- Pediatric Surgery
- Endocrinology
Background:
- Infants undergoing heart surgery, particularly in emerging programs with high malnutrition and mortality, face significant risks.
- Thyroid hormone levels are critical for post-operative recovery in pediatric cardiac surgery patients.
- Limited data exists on the efficacy of oral triiodothyronine (T3) in this vulnerable population.
Purpose of the Study:
- To evaluate the efficacy and safety of oral triiodothyronine (T3) on extubation time in infants under 5 months undergoing heart surgery.
- To assess the impact of T3 on post-operative complications such as low cardiac output syndrome, mortality, and infection.
- To explore T3's effect on different risk groups based on the Aristotle score.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 120 infants undergoing heart surgery.
- Patients received either oral triiodothyronine (T3) 1 μg/kg or placebo every 6 hours for 60 hours.
- Outcomes measured included time to extubation, serum FT3 levels, low cardiac output syndrome, mortality, and infection rates.
Main Results:
- The T3 group demonstrated significantly higher serum FT3 levels post-operatively.
- A lower incidence of low cardiac output syndrome was observed in the T3 group at 6 and 12 hours post-cross-clamp removal (p<0.05).
- While not statistically significant, the T3 group showed a trend towards shorter intubation times and lower mortality (p=0.07).
- In low-risk patients (Aristotle score < 10.0), T3 significantly reduced extubation time (p=0.021) and the likelihood of requiring CPR or experiencing infection (p<0.05).
Conclusions:
- Oral T3 supplementation effectively increased serum FT3 levels and reduced low cardiac output syndrome in infants undergoing heart surgery.
- Prophylactic oral T3 administration appears beneficial, particularly in improving extubation time for low-risk pediatric cardiac surgery patients.
- Further research may confirm T3's role in reducing mortality and other complications in high-malnutrition, high-mortality settings.
Abstract:
This study evaluates the efficacy and safety of oral triiodothyronine on time to extubation for infants less than 5 months undergoing heart surgery in Indonesia, and primarily relates to patients in emerging programs with high malnutrition and mortality. In this randomized, double-blind, placebo-controlled trial, oral triiodothyronine (T3, Tetronine®) 1 μg/kg-body weight/dose or placebo (saccharum lactis) was administered via nasogastric tube every 6 h for 60 h to treatment group. A total of 120 patients were randomized into T3 (61 patients) and placebo (59 patients) groups. The majority of the patients had moderate to severe malnutrition (55.83%) with a high post-operative mortality rate of 23.3%. The T3 group showed significantly higher serum FT3 levels from 1 until 48 h post cross-clamp removal (p < 0.0001), lower incidence of low cardiac output syndrome at both 6 h (28 [45.9%] vs. 39 [66.1%] patients, p = 0.03, OR 2.3, 95% CI: 1.10-4.81) and 12 h after cross-clamp removal (25 [41.7%] vs. 36 [63.2%], p = 0.02, OR 2.40, 95% CI: 1.14-5.05). Although not statistically significant, the treatment group had shorter median (IQR) intubation time (2.59 [1.25-5.24] vs. 3.77 [1.28-6.64] days, p = 0.16, HR 1.36, 95% CI: 0.88-2.09)] and lower mortality (10 [16.4%] vs. 18 [30.5%], p = 0.07]. Patients with Aristotle score < 10.0 (low risk) receiving T3 had faster extubation than placebo patients (p = 0.021, HR of 1.90, 95% CI: 1.10-3.28) and were significantly less likely to require CPR or experience infection (p = 0.027, OR 8.56, 95% CI:0.99-73.9 and p = 0.022, OR 4.09 95% CI: 1.16-14.4, respectively). Oral T3 supplementation reduced overall incidence of low cardiac output syndrome and significantly reduced the time to extubation in low-risk patients. Therefore, prophylactic oral T3 administration may be beneficial in these patients.Trial Registration: ClinicalTrials.gov NCT02222532.
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