Statistical analysis plan for early goal-directed therapy using a physiological holistic view - the ANDROMEDA-SHOCK: a randomized controlled trial.
Statistical analysis plan for early goal-directed therapy using a physiological holistic view - the ANDROMEDA-SHOCK: a randomized controlled trial.
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DOI：
10.5935/0103-507x.20180041
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发表时间：
2018-07
影响因子：
--
通讯作者：
Bakker J
中科院分区：
文献类型：
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作者：
Hernández G;Cavalcanti AB;Ospina-Tascón G;Dubin A;Hurtado FJ;Damiani LP;Friedman G;Castro R;Alegría L;Cecconi M;Teboul JL;Bakker J
ANDROMEDA-SHOCK是一项国际性、多中心、随机对照试验，在感染性休克患者中比较外周灌注靶向复苏与乳酸靶向复苏，以检验外周灌注靶向复苏与较低发病率和死亡率相关的假设。报告ANDROMEDA-SHOCK试验的统计分析计划。我们描述了试验设计、主要和次要目的、患者、随机化方法、干预措施、结局和样本量。我们描述了我们计划的主要，次要和三级结果的统计分析。我们还描述了亚组和敏感性分析。最后，我们提供了详细的介绍我们的结果，包括模拟表显示基线特征，血流动力学和灌注变量的演变，以及治疗对结果的影响。根据最佳试验实践，我们在锁定数据库和启动分析之前报告我们的统计分析计划和数据管理计划。我们预计，这一程序将防止分析偏倚，并提高报告结果的实用性。
ANDROMEDA-SHOCK is an international, multicenter, randomized controlled trial comparing peripheral perfusion-targeted resuscitation to lactate-targeted resuscitation in patients with septic shock in order to test the hypothesis that resuscitation targeting peripheral perfusion will be associated with lower morbidity and mortality. To report the statistical analysis plan for the ANDROMEDA-SHOCK trial. We describe the trial design, primary and secondary objectives, patients, methods of randomization, interventions, outcomes, and sample size. We describe our planned statistical analysis for the primary, secondary and tertiary outcomes. We also describe the subgroup and sensitivity analyses. Finally, we provide details for presenting our results, including mock tables showing baseline characteristics, the evolution of hemodynamic and perfusion variables, and the effects of treatments on outcomes. According to the best trial practice, we report our statistical analysis plan and data management plan prior to locking the database and initiating the analyses. We anticipate that this procedure will prevent analysis bias and enhance the utility of the reported results.