Control of hyperglycaemia in paediatric intensive care (CHiP): study protocol.
Control of hyperglycaemia in paediatric intensive care (CHiP): study protocol.
复制标题
DOI：
10.1186/1471-2431-10-5
复制
发表时间：
2010-02-05
期刊：
影响因子：
2.4
通讯作者：
Elbourne D
中科院分区：
文献类型：
--
作者：
Macrae D;Pappachan J;Grieve R;Parslow R;Nadel S;Schindler M;Baines P;Fortune PM;Slavik Z;Goldman A;Truesdale A;Betts H;Allen E;Snowdon C;Percy D;Broadhead M;Quick T;Peters M;Morris K;Tasker R;Elbourne D
越来越多的证据表明，严格的血糖（BG）控制可以改善重症成人的预后。儿童对手术或危重病表现出类似的高血压反应。然而，鉴于成熟差异和不同疾病谱，尚不清楚严格控制是否会使儿童受益。本研究是一项随机开放试验，包括两个平行组，旨在评估在英国接受重症监护的年龄≤ 16岁的儿童是否接受了通气，是否在损伤、大手术或与预期需要持续至少12小时治疗的危重疾病相关的损伤、大手术后或与预期需要持续至少12小时治疗相关的危重疾病相关的血管活性支持，严格控制将增加存活天数和30天时无机械通气的天数，并导致与重症监护治疗相关的一系列并发症的改善，并且具有成本效益。严格控制组的儿童将通过静脉输注接受胰岛素，滴定以维持BG在4 - 7.0 mmol/l之间。对照组的儿童将根据标准的当前血糖管理方法进行治疗。将对儿童进行随访，以确定出院至随机化后12个月期间的生命状态和医疗资源使用情况。将从创伤性脑损伤（TBI）亚组中获取关于总体健康状况、总体神经学结局、注意力和行为状态的信息。随机化后前30天内无呼吸机天数的差异2天被认为具有临床意义。保守假设两个试验组的标准差为1周，I类错误为1%（双侧检验），并考虑到不依从性，1000例患者的总样本量将有90%的把握度检测到该差异。为了检测心脏和非心脏患者之间的效应差异，需要1500例目标样本量。经济学评价将评估实现严格血糖控制的成本是否因随后住院费用的降低而合理。在被接受为标准实践之前，需要对该人群中严格血糖控制的相关性进行正式评估。当前对照试验ISRCTN 61735247
There is increasing evidence that tight blood glucose (BG) control improves outcomes in critically ill adults. Children show similar hyperglycaemic responses to surgery or critical illness. However it is not known whether tight control will benefit children given maturational differences and different disease spectrum. The study is an randomised open trial with two parallel groups to assess whether, for children undergoing intensive care in the UK aged ≤ 16 years who are ventilated, have an arterial line in-situ and are receiving vasoactive support following injury, major surgery or in association with critical illness in whom it is anticipated such treatment will be required to continue for at least 12 hours, tight control will increase the numbers of days alive and free of mechanical ventilation at 30 days, and lead to improvement in a range of complications associated with intensive care treatment and be cost effective. Children in the tight control group will receive insulin by intravenous infusion titrated to maintain BG between 4 and 7.0 mmol/l. Children in the control group will be treated according to a standard current approach to BG management. Children will be followed up to determine vital status and healthcare resources usage between discharge and 12 months post-randomisation. Information regarding overall health status, global neurological outcome, attention and behavioural status will be sought from a subgroup with traumatic brain injury (TBI). A difference of 2 days in the number of ventilator-free days within the first 30 days post-randomisation is considered clinically important. Conservatively assuming a standard deviation of a week across both trial arms, a type I error of 1% (2-sided test), and allowing for non-compliance, a total sample size of 1000 patients would have 90% power to detect this difference. To detect effect differences between cardiac and non-cardiac patients, a target sample size of 1500 is required. An economic evaluation will assess whether the costs of achieving tight BG control are justified by subsequent reductions in hospitalisation costs. The relevance of tight glycaemic control in this population needs to be assessed formally before being accepted into standard practice. Current Controlled Trials ISRCTN61735247
登录
查看更多内容
DOI：
10.1097/00075197-199903000-00014
发表时间：
1999-03-01
影响因子：
3.1
作者：
Ferrando, A A
通讯作者：
Ferrando, A A
影响因子：
2.2
作者：
Gearhart, Michelle M.;Parbhoo, Shilpa K.
通讯作者：
Parbhoo, Shilpa K.
影响因子：
5.1
作者：
Faustino, EV;Apkon, M
通讯作者：
Apkon, M
影响因子：
7.7
作者：
Ceriello, A;Quagliaro, L;Giugliano, D
通讯作者：
Giugliano, D
影响因子：
4.6
作者：
Furnary, AP;Zerr, KJ;Starr, A
通讯作者：
Starr, A