Lopez-Rolon Alex, Bender Andreas
Department of Neurology, University of Munich, Marchioninistr. 15, Munich, D-81377, Germany.
Therapiezentrum Burgau, Burgau, Germany.
BMC Neurol. 2015 May 15;15:82. doi: 10.1186/s12883-015-0337-x.
The number of resuscitated cardiac arrest patients suffering from anoxic-ischemic encephalopathy is considerable. However, outcome prediction parameters such as somatosensory evoked potentials need revision because they are based on data predating the implementation of mild therapeutical hypothermia and because data from our own laboratory suggest that they may fail to predict prognosis accurately. The present research project "Hypoxia and Outcome Prediction in Early-Stage Coma" is an ongoing observational prospective cohort study that aims to improve outcome prediction in anoxic coma by limiting the effects of falsely pessimistic predictions at the intensive care unit.
Our outcome analysis is based on functional and behavioural definitions. This implies the analysis of the positive predictive value of prognostic markers yielding either positive or negative results. We also analyse the effect of covariates adjusted for age and sex such as sociodemographic variables, prognostic variables and treatment factors on functional and behavioural outcomes, with mixed effects regression models (i.e. fixed and random effects). We expect to enrol 172 patients based on the result of previous research. The null hypothesis is that there is a probability of <10 % that a positive outcome will be observed despite the presence of any of the predictors of a poor/negative outcome. We test the null hypothesis against a one-sided alternative using a Simon's two-stage design to determine whether it is warranted to recruit the full number of patients suggested by a power analysis. The second stage has a design with a Type I error rate of 0.05 and 80 % power if the true response rate is 25 %.
We aim to make a significant contribution to the revision and improvement of current outcome prediction methods in anoxic-ischemic encephalopathy patients. As a result, neurocritical care specialists worldwide will have considerably more accurate methods for prognosticating the outcome of anoxic-ischemic encephalopathy following cardiac arrest. This will facilitate the provision of treatment tailored to individual patients and the attainment of an optimal quality of life. It will also inform the decision to withdraw treatment with a level of accuracy never seen before in the field.
ClinicalTrials.gov NCT02231060 (registered 29 August 2014).
因缺氧缺血性脑病而复苏成功的心脏骤停患者数量可观。然而，诸如体感诱发电位等预后预测参数需要修订，因为它们基于轻度治疗性低温实施之前的数据，且我们自己实验室的数据表明这些参数可能无法准确预测预后。当前的研究项目“早期昏迷中的缺氧与预后预测”是一项正在进行的观察性前瞻性队列研究，旨在通过限制重症监护病房中错误悲观预测的影响来改善缺氧性昏迷的预后预测。
我们的预后分析基于功能和行为定义。这意味着要分析产生阳性或阴性结果的预后标志物的阳性预测值。我们还使用混合效应回归模型（即固定效应和随机效应）分析经年龄和性别调整的协变量（如社会人口统计学变量、预后变量和治疗因素）对功能和行为结果的影响。根据先前研究的结果，我们预计招募172名患者。零假设是，尽管存在任何不良/阴性结果的预测因素，但观察到阳性结果的概率小于10%。我们使用西蒙两阶段设计针对单侧备择假设检验零假设，以确定是否有必要招募功效分析建议的全部患者数量。如果真实反应率为25%，第二阶段的设计具有0.05的I型错误率和80%的功效。
我们旨在为缺氧缺血性脑病患者当前预后预测方法的修订和改进做出重大贡献。因此，全球神经重症监护专家将拥有更为准确得多的方法来预测心脏骤停后缺氧缺血性脑病的预后。这将有助于提供针对个体患者的治疗并实现最佳生活质量。它还将以前所未有的准确性为撤掉治疗的决策提供依据。
ClinicalTrials.gov NCT02231060（2014年8月29日注册）
