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.

本研究评估了在印度尼西亚接受心脏手术的 5 个月以下婴儿按时拔管口服三碘甲状腺原氨酸的疗效和安全性，主要涉及营养不良和死亡率高的新兴项目中的患者。在这项随机、双盲、安慰剂对照试验中，治疗组每 6 小时通过鼻胃管给予口服三碘甲状腺原氨酸（T3，Tetronine®）1 μg/kg 体重/剂量或安慰剂（乳酸甘蔗），持续 60 小时. 共有 120 名患者被随机分为 T3（61 名患者）和安慰剂（59 名患者）组。大多数患者存在中度至重度营养不良（55.83%），术后死亡率高达23.3%。T3 组在去除交叉钳后 1 至 48 小时的血清 FT3 水平显着升高（p< 0.0001)，交叉后 6 小时（28 [45.9%] 对 39 [66.1%] 患者， p  = 0.03，OR 2.3，95% CI：1.10–4.81）和 12 小时 的低心输出量综合征发生率较低- 夹钳去除（25 [41.7%] 对 36 [63.2%]，p  = 0.02，或 2.40，95% CI：1.14–5.05）。虽然没有统计学意义，但治疗组的中位 (IQR) 插管时间较短（2.59 [1.25–5.24] 对 3.77 [1.28–6.64] 天，p  = 0.16，HR 1.36，95% CI：0.88–2.09）] 和死亡率更低（10 [16.4%] vs. 18 [30.5%]，p  = 0.07]。接受 T3 治疗的亚里士多德评分 < 10.0（低风险）的患者拔管速度比安慰剂患者快（p  = 0.021，HR 为 1.90，95% CI：1.10–3.28）并且需要心肺复苏术或经历感染的可能性显着降低（p  = 0.027, OR 8.56, 95% CI: 0.99–73.9 和p  = 0.022, OR 4.09 95% CI: 1.16–14.4）。口服 T3 补充剂降低了低心输出量综合征的总体发病率，并显着缩短了低风险患者的拔管时间。因此，预防性口服 T3 给药可能对这些患者有益。

试验注册：ClinicalTrials.gov NCT02222532。