Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass

心肺绕道术后婴儿的第三阶段三碘甲状腺原氨酸补充

• 批准号: 9117980
• 负责人: Michael A Portman
• 金额: $ 40万
• 依托单位: SEATTLE CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-08-15 至 2018-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9117980
• 关键词: Phase; Triiodothyronine; Supplementation; Infants; After

DESCRIPTION (provided by applicant): Over the past 20 years increasing numbers of patients have undergone cardiopulmonary bypass for correction of congenital heart defects and or palliation of single ventricle type anatomy. While technical advances have been made in these surgical procedures, progress has been limited with regard to pharmacologic management of infants during the postoperative period. Although rapid extubation strategies have been applied at many centers in older infants and children, neonates and young infants still demonstrate morbidity after surgery, often resulting in prolonged time on mechanical ventilation. It was reported by the applicant that the recent Triiodothyronine Supplementation in Infants and Children Undergoing Cardiopulmonary Bypass (TRICC) clinical trial demonstrated that triiodothyronine supplementation with Triostat (liothyronine) reduced time on the ventilator after surgical procedures using cardiopulmonary bypass in infants under 5 months of age. However, the study design did not provide data in the format required by the Food and Drug Administration (FDA) for an indication change on the label for this drug. To apply for the labeling change for triiodothyronine (liothyronine) and significantly impact the current standard of care, the investigators aim to prospectively study the specific age groups. In the proposed study the hypothesis that triiodothyronine supplementation after cardiopulmonary bypass (CPB) in infants improves clinical outcome will be tested. This Phase 3, randomized, double-blind, placebo-controlled trial aims to obtain results confirming those of the TRICC trial that triiodothyronine supplementation with Triostat (liothyronine) in infants under 5 months of age reduces time on the ventilator after surgical procedures using cardiopulmonary bypass and confirming that triiodothyronine supplementation is safe in this age group after cardiopulmonary bypass.

描述（由申请人提供）： 在过去的20年中，越来越多的患者经历了心肺旁路，以纠正先天性心脏缺陷和 /或单脑室型解剖结构。尽管在这些外科手术程序中已经取得了进步，但在术后婴儿的药理学管理方面的进展受到限制。尽管在许多年龄较大的婴儿和儿童中已经采用了快速的拔管策略，但新生儿和年轻婴儿仍表现出手术后的发病率，通常会导致机械通气的时间延长。 申请人报道说，最近的三碘甲状腺素补充剂和接受心肺旁路的儿童（TRICC）临床试验表明，三碘甲氨酸补充三硫代氨基氨酸（liothyronine）在使用心脏呼吸旁旁路的手术后的手术手术后，在院子节上减少了频率的时间。 但是，研究设计并未提供食品药物管理局（FDA）要求的格式的数据，以表明该药物标签的标签更改。 为了申请三碘甲氨酸（liothyronine）的标签变化，并显着影响当前的护理标准，研究人员旨在前瞻性地研究特定年龄组。 在拟议的研究中，婴儿将在婴儿中补充三碘甲状腺素补充剂（CPB）在婴儿中得到改善的临床结果。 This Phase 3, randomized, double-blind, placebo-controlled trial aims to obtain results confirming those of the TRICC trial that triiodothyronine supplementation with Triostat (liothyronine) in infants under 5 months of age reduces time on the ventilator after surgical procedures using cardiopulmonary bypass and confirming that triiodothyronine supplementation is safe in this age group after心肺旁路。