Design and rationale of Heart and Lung Failure - Pediatric INsulin Titration Trial (HALF-PINT): A randomized clinical trial of tight glycemic control in hyperglycemic critically ill children
Design and rationale of Heart and Lung Failure - Pediatric INsulin Titration Trial (HALF-PINT): A randomized clinical trial of tight glycemic control in hyperglycemic critically ill children
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DOI：
10.1016/j.cct.2016.12.023
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发表时间：
2017-02-01
影响因子：
2.2
通讯作者：
Nadkarni, Vinay M.
中科院分区：
文献类型：
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作者：
Agus, Michael S. D.;Hirshberg, Ellie;Nadkarni, Vinay M.
目的：测试是否高血糖重症儿童心血管和/或呼吸衰竭经验更多的ICU免费天时，分配到严格的血糖控制与正常血糖与高血糖的目标范围。设计：多中心随机临床试验。设置：儿科ICU在35个学术医院。患者：接受正性肌力支持和/或急性机械通气的2周至17岁儿童，不包括心脏手术患者。患者接受静脉胰岛素滴定至80-110 mg/dL（4.4-6.1 mmol/L）或150 - 180 mg/dL（8.3-10.0 mmol/L）。干预在确认高血糖时开始，并在患者符合研究定义的ICU出院标准或28天后结束。动态葡萄糖监测，最低限度的葡萄糖输注，并明确胰岛素输注算法部署，以实现血糖目标，同时最大限度地降低低血糖risk. Measures和主要结果：主要结果是ICU免费天（相当于28天的住院死亡率调整ICU住院时间）。次要结局包括90天住院死亡率、器官功能障碍评分、无呼吸机天数、医院感染率、神经发育结局和护理世界。检测无ICU天数增加125天（相当于28天住院死亡率相对减少20%，ICU住院时间减少1天），使用双侧0.05水平检验，需要1414例患者才能获得80%的把握度。这项试验测试了随机分配到80-110 mg/dL的高血糖重症儿童是否比随机分配到150-180 mg/dL的儿童获益更多。本研究实施了经验证的床边支持工具，包括连续血糖监测和计算机化算法，以提高患者安全性，并确保在实现血糖控制方面的可重复床边决策。(C)2017作者爱思唯尔公司出版
Objectives: Test whether hyperglycemic critically ill children with cardiovascular and/or respiratory failure experience more ICU-free days when assigned to tight glycemic control with a normoglycemic versus hyperglycemic blood glucose target range.Design: Multi-center randomized clinical trial.Setting: Pediatric ICUs at 35 academic hospitals.Patients: Children aged 2 weeks to 17 years receiving inotropic support and/or acute mechanical ventilation, excluding cardiac surgical patients.Interventions: Patients receive intravenous insulin titrated to either 80-110 mg/dL (4.4-6.1 mmol/L) or 150180 mg/dL (8.3-10.0 mmol/L). The intervention begins upon confirmed hyperglycemia and ends when the patient meets study-defined ICU discharge criteria or after 28 days. Continuous glucose monitoring, a minimum glucose infusion, and an explicit insulin infusion algorithm are deployed to achieve the BG targets while minimizing hypoglycemia risk.Measurements and main results: The primary outcome is ICU-free days (equivalent to 28-day hospital mortality adjusted ICU length of stay). Secondary outcomes include 90-day hospital mortality, organ dysfunction scores, ventilator-free days, nosocomial infection rate, neurodevelopmental outcomes, and nursing worldoad. To detect an increase of 125 ICU-free days (corresponding to a 20% relative reduction in 28-day hospital mortality and a one-day reduction in ICU length of stay), 1414 patients are needed for 80% power using a two-sided 0.05 level test.Conclusions: This trial tests whether hyperglycemic critically ill children randomized to 80-110 mg/dL benefit more than those randomized to 150-180 mg/dL. This study implements validated bedside support tools including continuous glucose monitoring and a computerized algorithm to enhance patient safety and ensure reproducible bedside decision-making in achieving glycemic control. (C) 2017 The Authors. Published by Elsevier Inc.