656 |
Marwali E.M., Lopolisa A., Sani A.A., Rayhan M., Roebiono P.S., Fakhri D., Haas N.A., Slee A., Portman M.A. |
36608535400;57358496100;57209881028;57219904946;57192895321;8599513100;7103216848;7004895873;7004985824; |
Indonesian Study: Triiodothyronine for Infants Less than 5 Months Undergoing Cardiopulmonary Bypass |
2021 |
Pediatric Cardiology |
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https://www.scopus.com/inward/record.uri?eid=2-s2.0-85120384775&doi=10.1007%2fs00246-021-02779-8&partnerID=40&md5=ee32a32dc863edb4c293caf61a4c9fea |
Pediatric Cardiac Intensive Care Unit, National Cardiovascular Center Harapan Kita, Jakarta, Indonesia; Department of Cardiology and Vascular Medicine, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia; Pediatric Cardiology Unit, National Cardiovascular Center Harapan Kita, Jakarta, Indonesia; Pediatric Cardiac Surgery Unit, National Cardiovascular Center Harapan Kita, Department of Cardiothoracic Vascular Surgery, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia; Department of Pediatric Cardiology and Pediatric Intensive Care, Medical Hospital of the University of Munich, Munich, Germany; Axio Research, Seattle Children’s Hospital and Research Institute, Seattle, United States; Seattle Children’s Hospital, University of Washington, Seattle, WA, United States; National Cardiovascular Center Harapan Kita, Jl. Let. Jend. S. Parman, Kav 87, Slipi, West Jakarta 11420, Indonesia |
Marwali, E.M., Pediatric Cardiac Intensive Care Unit, National Cardiovascular Center Harapan Kita, Jakarta, Indonesia, Department of Cardiology and Vascular Medicine, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia, National Cardiovascular Center Harapan Kita, Jl. Let. Jend. S. Parman, Kav 87, Slipi, West Jakarta 11420, Indonesia; Lopolisa, A., Pediatric Cardiac Intensive Care Unit, National Cardiovascular Center Harapan Kita, Jakarta, Indonesia; Sani, A.A., Pediatric Cardiac Intensive Care Unit, National Cardiovascular Center Harapan Kita, Jakarta, Indonesia; Rayhan, M., Pediatric Cardiac Intensive Care Unit, National Cardiovascular Center Harapan Kita, Jakarta, Indonesia; Roebiono, P.S., Department of Cardiology and Vascular Medicine, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia, Pediatric Cardiology Unit, National Cardiovascular Center Harapan Kita, Jakarta, Indonesia; Fakhri, D., Pediatric Cardiac Surgery Unit, National Cardiovascular Center Harapan Kita, Department of Cardiothoracic Vascular Surgery, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia; Haas, N.A., Department of Pediatric Cardiology and Pediatric Intensive Care, Medical Hospital of the University of Munich, Munich, Germany; Slee, A., Axio Research, Seattle Children’s Hospital and Research Institute, Seattle, United States; Portman, M.A., Seattle Children’s Hospital, University of Washington, Seattle, WA, United States |
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. © 2021, The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature. |
Congenital open cardiac surgery; Low cardiac output; Time-to-extubation; Triiodothyronine |
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Springer |
01720643 |
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Article |
Q2 |
646 |
7791 |
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