SPECS: Safe Pediatric Euglycemia in Cardiac Surgery

描述(由申请人提供)：心脏手术中正常血糖的安全儿科试验(SPECS)危重新生儿和儿童通常会出现应激性高血糖，这与发病率和死亡率的增加显著相关。在危重成人中，几项临床试验发现，通过静脉注射胰岛素治疗严格控制血糖可以降低发病率和死亡率，主要是通过减少脓毒症的发生率。最近发展和验证的持续血糖监测现在允许对危重儿童安全地使用胰岛素，将严重低血糖的风险降至最低。这项拟议的研究试图验证这样一种假设，即应用安全、严格的血糖控制和胰岛素输注将改善儿童心脏手术患者的术后结果。到目前为止，还没有严格控制血糖的儿科随机试验。本研究结果将为儿科危重患者术后高血糖的治疗提供必要的证据，并加深对代谢因素对术后恢复影响的认识。建议一项单中心前瞻性随机对照试验，采用持续血糖监测和胰岛素输注来维持3岁以下儿童心脏手术后的正常血糖。该方案旨在确定应用严格的血糖控制是否会降低医院感染率，并检查正常血糖对器官系统恢复和功能的影响。这项创新的研究有可能改善新生儿、婴儿和先天性心脏缺陷儿童的管理，降低术后发病率，并对确定所有儿科危重患者是否需要严格控制血糖具有重要意义。危重儿童在患病期间通常会出现血糖升高，这已被证明与较差的预后有关。成人研究表明，严格将血糖维持在正常范围内可以降低死亡率并改善预后，但由于胰岛素注射和可能的低血糖的安全问题，这一点从未在儿童身上进行过测试。这项研究将使用新的可用和有效的持续血糖监测来检测和预防低血糖，并允许安全地将血糖维持在正常范围内，以测试严格控制心脏直视手术后危重儿童血糖的价值。

DESCRIPTION (provided by applicant): Safe Pediatric Trial of Euglycemia in Cardiac Surgery (SPECS) Critically ill neonates and children commonly develop stress hyperglycemia which is significantly associated with increased morbidity and mortality. In critically ill adults several clinical trials have found that tight glycemic control with intravenous insulin therapy decreases morbidity and mortality, primarily through decreased incidence of sepsis. The recent development and validation of continuous glucose monitoring now allows safe administration of insulin to critically ill children with minimized risk of severe hypoglycemia. The proposed study seeks to test the hypothesis that the application of safe tight glycemic control with insulin infusion will result in improved post-operative outcomes in pediatric cardiac surgery patients. To date, there have been no pediatric randomized trials of tight glycemic control. The results of this study will provide much needed evidence for treatment of hyperglycemia in post-operative critically ill pediatric patients and advance the understanding of the impact of metabolic factors on post-operative recovery. A single-center prospective randomized controlled trial is proposed employing continuous glucose monitoring and insulin infusion to maintain euglycemia in post-operative pediatric cardiac surgery patients less than three years of age. The protocol is designed to determine if the application of tight glycemic control will result in a decreased rate of nosocomial infection, and to examine the effect of euglycemia on organ system recovery and function. This innovative investigation has the potential to lead to improved management and decreased post- operative morbidity in neonates, infants, and children with congenital cardiac defects and is important in defining the need for tight glycemic control in all pediatric critically ill patients. Critically ill children commonly develop elevated blood sugars during their illness which has been demonstrated to be associated with poorer outcome. Adult studies have shown that strict maintenance of the blood sugar in the normal range reduces mortality and improves outcome, but this has never been tested in children due to the safety issues around insulin infusion and possible low blood sugars. This study will test the value of strict control of the blood sugar in critically ill children after open heart surgery using newly available and validated continuous blood sugar monitoring to detect and prevent low blood sugars, and to allow for safe maintenance of the blood sugar within the normal range.