STRoke Adverse Outcome is Associated with NoSocomial Infections (STRAWINSKI): Procalcitonin Ultrasensitive-Guided Antibacterial Therapy in Severe Ischaemic Stroke Patients – Rationale and Protocol for a Randomized Controlled Trial

STRoke Adverse Outcome is Associated with NoSocomial Infections (STRAWINSKI): Procalcitonin Ultrasensitive-Guided Antibacterial Therapy in Severe Ischaemic Stroke Patients – Rationale and Protocol for a Randomized Controlled Trial
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中风不良结果与NoSocomial感染相关(STRAWINSKI):降钙素原超敏引导重度缺血性中风患者的抗菌治疗——随机对照试验的基本原理和方案

DOI:
10.1111/j.1747-4949.2012.00858.x
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发表时间:
2013
影响因子:
6.7
通讯作者:
Meisel A
Meisel A
中科院分区:
医学2区
文献类型:
--
作者:
Ohlraun S;Harms H;Hoffmann S;Klehmet J;Ebmeyer S;Hartmann O;Meisel C;Anker SD;Meisel A

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基本原理中风相关性肺炎是中风患者预后不良的最常见原因之一。中风相关感染的临床症状和实验室参数通常是不确定的。生物标志物可能有助于识别肺炎高危中风患者,并指导医生进行早期抗生素治疗,从而改善中风结局。目的本研究的目的是调查降钙素原超敏引导的抗生素治疗是否可以通过早期治疗肺炎来改善严重缺血性中风后的功能结局。设计STRAWINSKI是一项研究者发起的、多中心、随机、对照试验,对降钙素原超敏引导的抗生素治疗与标准护理进行比较,对结果进行盲法评估。研究200名患者大脑中动脉区域缺血性中风且美国国立卫生研究院中风量表得分> 9的患者将被纳入并随机分配到两组。一组将接受基于降钙素原的抗生素治疗指导;另一组将接受标准卒中单元护理。 结果 主要终点是卒中后第 90 天的功能性结果(根据改良 Rankin 量表),分为有利结果 (0–4) 或不利结果 (,–)。次要终点是首次发生死亡、再住院或卒中复发的时间;死亡率、感染率以及直至第 7 天的发烧天数;住院时间和出院处理;改良Rankin量表的平移分析; Barthel 指数以及第 90 天的存活天数和出院天数;使用抗生素直至第 90 天;以及第 180 天时的改良 Rankin 量表、Barthel 指数和梗塞体积。
RationaleStroke-associated pneumonia is one of the most common causes of poor outcome in stroke patients. Clinical signs and laboratory parameters of stroke-associated infections are often inconclusive. Biomarkers may help to identify stroke patients at high risk for pneumonia and to guide physicians in an early antibiotic treatment, thereby improving stroke outcome.AimThe aim of the present study is to investigate whether procalcitonin ultrasensitive-guided antibiotic treatment improves functional outcome after severe ischaemic stroke by early treatment of pneumonia.DesignSTRAWINSKI is an investigator-initiated, multicentre, randomized, controlled trial with blinded assessment of outcome comparing procalcitonin ultrasensitive-guided antibiotic treatment with standard care.Study200 patients with ischaemic stroke in the middle cerebral artery territory and a score >9 on the National Institutes of Health Stroke Scale will be included and randomly assigned to two groups. One group will receive procalcitonin-based antibiotic therapy guidance; the other group will receive standard stroke unit care.OutcomesThe primary endpoint is functional outcome at day 90 after stroke on the modified Rankin Scale, dichotomized as favourable (0–4) or unfavourable outcome (,–). Secondary endpoints are time to first event of death, rehospitalization, or recurrent stroke; death rate, infection rate, and days with fever up to day 7; length of hospital stay and hospital discharge disposition; shift analysis of the modified Rankin Scale; Barthel Index and days alive and out of hospital at day 90; use of antibiotics until day 90; and modified Rankin Scale, Barthel Index, and infarct volume at day 180.
DOI: 10.1016/s0140-6736(99)04407-4
发表时间: 1999-10-23
期刊: LANCET
影响因子: 168.9
作者:
Hankey, GJ;Warlow, CI
通讯作者: Warlow, CI
DOI: 10.1111/j.1747-4949.2010.00555.x
发表时间: 2011-04-01
影响因子: 6.7
作者:
Nederkoorn, Paul J.;Westendorp, Willeke F.;van de Beek, Diederik
通讯作者: van de Beek, Diederik
缺血性中风和短暂性脑缺血发作管理指南 2008 年
DOI: --
发表时间: 2008
期刊:
影响因子: --
作者:
Eso Writing
通讯作者: Eso Writing
DOI: 10.1371/journal.pone.0002158
发表时间: 2008-05-14
期刊: PloS one
影响因子: 3.7
作者:
Harms H;Prass K;Meisel C;Klehmet J;Rogge W;Drenckhahn C;Göhler J;Bereswill S;Göbel U;Wernecke KD;Wolf T;Arnold G;Halle E;Volk HD;Dirnagl U;Meisel A
通讯作者: Meisel A
DOI: 10.1016/s1474-4422(07)70036-4
发表时间: 2007-03-01
期刊: LANCET NEUROLOGY
影响因子: 48
作者:
Vahedi, Katayoun;Hofmeijer, Jeannette;Hacke, Werner
通讯作者: Hacke, Werner