SPECS: Safe Pediatric Euglycemia in Cardiac Surgery

规格：心脏手术中安全的小儿血糖正常

• 批准号: 7848217
• 负责人: MICHAEL SD AGUS
• 金额: $ 78.96万
• 依托单位: BOSTON CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-06-01 至 2012-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7848217
• 关键词: Adult; Age-Years; Arrhythmia; Blood Glucose; Boston; C-reactive protein; Cardiac; Cardiac Surgery procedures; Cardiopulmonary Bypass; Catabolism; Child; Childhood; Clinical Trials; Congenital Heart Defects; Control Groups; Critical Illness; Critically ill children; Development; Endocrine; Endocrine Glands; Energy Metabolism; Enrollment; Ensure; Equation; Equilibrium; Fluid Balance; Glucose; Hepatic; Histidine; Hormones; Hour; Hyperglycemia; Hypoglycemia; Immune; Incidence; Indirect Calorimetry; Infant; Infusion procedures; Insulin; Insulin Resistance; Insulin-Like Growth-Factor Binding Protein 1; Intensive Care Units; Intervention; Intratracheal Intubation; Intravenous; Investigation; Lead; Length of Stay; Maintenance; Measures; Metabolic; Monitor; Morbidity - disease rate; Normal Range; Nosocomial Infections; Nutritional; Nutritional status; Outcome; Outcome Measure; Oxygen; Patients; Pediatric Hospitals; Population; Postoperative Period; Proteins; Protocols documentation; Randomized Controlled Trials; Recovery; Recovery of Function; Research Personnel; Rest; Risk; Safety; Sepsis; Serum; Stress; Testing; Time; Validation; Venous; White Blood Cell Count procedure; base; biological adaptation to stress; body system; design; glucose monitor; glycemic control; immune function; improved; improved functioning; indexing; innovation; mortality; neonate; nitrogen balance; prevent; primary outcome; programs; prospective; randomized trial; secondary outcome; standard of care; urinary

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.

描述（由申请人提供）：心脏手术中血糖正常的安全儿科试验 (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着相关。在危重成人中，多项临床试验发现，通过静脉注射胰岛素治疗严格控制血糖可降低发病率和死亡率，主要是通过降低败血症的发生率来实现。最近连续血糖监测的发展和验证现在可以为危重儿童安全注射胰岛素，并将严重低血糖的风险降至最低。拟议的研究旨在检验以下假设：应用胰岛素输注安全严格的血糖控制将改善小儿心脏手术患者的术后结果。迄今为止，还没有严格血糖控制的儿科随机试验。这项研究的结果将为术后危重儿科患者高血糖的治疗提供急需的证据，并加深对代谢因素对术后恢复影响的理解。提出一项单中心前瞻性随机对照试验，采用连续血糖监测和胰岛素输注来维持三岁以下小儿心脏手术术后患者的血糖正常。该方案旨在确定严格血糖控制的应用是否会导致院内感染率降低，并检查血糖正常对器官系统恢复和功能的影响。这项创新研究有可能改善患有先天性心脏缺陷的新生儿、婴儿和儿童的治疗并降低术后发病率，并且对于确定所有儿科危重患者严格血糖控制的必要性非常重要。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相关。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，但由于胰岛素输注的安全问题和可能的低血糖，这一点从未在儿童中进行过测试。这项研究将使用新近可用且经过验证的连续血糖监测来测试心脏直视手术后严格控制血糖的价值，以检测和预防低血糖，并将血糖安全维持在正常范围内。