From Royal Brompton and Harefield NHS Foundation Trust (D.M.) and the Departments of Health Services Research and Policy (R.G., Z.S.) and Medical Statistics (E.A., D.E.) and the Clinical Trials Unit (E.A., D.E.), London School of Hygiene and Tropical Medicine, London, Birmingham Children's Hospital, Birmingham (K.M.), University Hospital Southampton NHS Foundation Trust, Southampton (J.P.), and the Division of Epidemiology, Leeds Institute of Genetics and Therapeutics, Faculty of Medicine and Health, University of Leeds, Leeds (R.P.) - all in the United Kingdom; and the Departments of Neurology and Anesthesia, Boston Children's Hospital and Harvard Medical School, Boston (R.C.T.).
N Engl J Med. 2014 Jan 9;370(2):107-18. doi: 10.1056/NEJMoa1302564.
Whether an insulin infusion should be used for tight control of hyperglycemia in critically ill children remains unclear.
We randomly assigned children (≤16 years of age) who were admitted to the pediatric intensive care unit (ICU) and were expected to require mechanical ventilation and vasoactive drugs for at least 12 hours to either tight glycemic control, with a target blood glucose range of 72 to 126 mg per deciliter (4.0 to 7.0 mmol per liter), or conventional glycemic control, with a target level below 216 mg per deciliter (12.0 mmol per liter). The primary outcome was the number of days alive and free from mechanical ventilation at 30 days after randomization. The main prespecified subgroup analysis compared children who had undergone cardiac surgery with those who had not. We also assessed costs of hospital and community health services.
A total of 1369 patients at 13 centers in England underwent randomization: 694 to tight glycemic control and 675 to conventional glycemic control; 60% had undergone cardiac surgery. The mean between-group difference in the number of days alive and free from mechanical ventilation at 30 days was 0.36 days (95% confidence interval [CI], -0.42 to 1.14); the effects did not differ according to subgroup. Severe hypoglycemia (blood glucose, <36 mg per deciliter [2.0 mmol per liter]) occurred in a higher proportion of children in the tight-glycemic-control group than in the conventional-glycemic-control group (7.3% vs. 1.5%, P<0.001). Overall, the mean 12-month costs were lower in the tight-glycemic-control group than in the conventional-glycemic-control group. The mean 12-month costs were similar in the two groups in the cardiac-surgery subgroup, but in the subgroup that had not undergone cardiac surgery, the mean cost was significantly lower in the tight-glycemic-control group than in the conventional-glycemic-control group: -$13,120 (95% CI, -$24,682 to -$1,559).
This multicenter, randomized trial showed that tight glycemic control in critically ill children had no significant effect on major clinical outcomes, although the incidence of hypoglycemia was higher with tight glucose control than with conventional glucose control. (Funded by the National Institute for Health Research, Health Technology Assessment Program, U.K. National Health Service; CHiP Current Controlled Trials number, ISRCTN61735247.).
在危重病儿童中，是否应使用胰岛素输注来严格控制高血糖仍不清楚。
我们将预计需要机械通气和血管活性药物至少 12 小时的儿科重症监护病房（ICU）患儿（≤16 岁）随机分配至强化血糖控制组，目标血糖范围为 72 至 126mg/dL（4.0 至 7.0mmol/L），或常规血糖控制组，目标水平低于 216mg/dL（12.0mmol/L）。主要结局为随机分组后 30 天存活且无需机械通气的天数。主要预先指定的亚组分析比较了接受心脏手术与未接受心脏手术的患儿。我们还评估了医院和社区卫生服务的费用。
在英国 13 个中心的 1369 名患儿接受了随机分组：694 名患儿接受强化血糖控制，675 名患儿接受常规血糖控制；60%患儿接受了心脏手术。强化血糖控制组与常规血糖控制组在 30 天存活且无需机械通气的天数差异的平均值为 0.36 天（95%置信区间，-0.42 至 1.14）；亚组间的效果无差异。强化血糖控制组低血糖（血糖<36mg/dL[2.0mmol/L]）的发生率高于常规血糖控制组（7.3% vs.1.5%，P<0.001）。总体而言，强化血糖控制组的 12 个月平均费用低于常规血糖控制组。在心脏手术亚组中，两组的 12 个月平均费用相似，但在未接受心脏手术的亚组中，强化血糖控制组的平均费用明显低于常规血糖控制组：-13120 美元（95%置信区间，-24682 至-1559 美元）。
这项多中心随机试验表明，危重病儿童的强化血糖控制对主要临床结局无显著影响，尽管强化血糖控制的低血糖发生率高于常规血糖控制。（由英国国民保健署国家卫生研究院卫生技术评估计划资助；CHiP 当前对照试验编号，ISRCTN61735247。）
