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（规格）重症新生儿和儿童的安全小儿试验通常会出现压力高血糖，这与发病率和死亡率的增加显着相关。在重病的成年人中，几项临床试验发现，静脉胰岛素治疗的严重血糖控制降低了发病率和死亡率，主要是通过败血症的发病率降低。现在，连续葡萄糖监测的最新发展和验证允许安全地施用胰岛素，以最大程度地减少严重低血糖风险的危重儿童。拟议的研究旨在检验以下假设：将安全的紧密血糖控制与胰岛素输注的应用将导致儿科心脏手术患者的术后结局改善。迄今为止，还没有进行严重血糖控制的小儿随机试验。这项研究的结果将提供急需的证据，以治疗术后患儿科患者的高血糖，并提高对代谢因素对术后康复的影响的理解。提出了一项单一中心的前瞻性随机对照试验，该试验采用连续的葡萄糖监测和胰岛素输注来维持术后儿科心脏手术患者的尤利克血症，以维持尤利西亚。该方案旨在确定严格的血糖控制的应用是否会导致医院感染的率降低，并检查尤利克米亚对器官系统恢复和功能的影响。这项创新的研究有可能导致改善管理，婴儿和先天性心脏缺陷儿童的管理后发病率，并且对于确定所有儿科患者的严重血糖控制的需求很重要。重症儿童通常在患病期间会出现升高的血糖，这已被证明与较差的结果有关。成人研究表明，正常范围内血糖的严格维持会降低死亡率并改善预后，但是由于胰岛素输注和可能的低血糖的安全问题，儿童从未在儿童中进行过测试。这项研究将在心脏手术后，使用新近可用并经过验证的连续血糖监测来检测和预防低血糖，并允许在正常范围内安全维持血糖的情况下，测试严重控制重症儿童血糖的价值。