Kotsopoulos Angela M M, Vos Piet, Jansen Nichon E, Bronkhorst Ewald M, van der Hoeven Johannes G, Abdo Wilson F
Department of Intensive Care, Radboudumc, Nijmegen, Netherlands.
Department of Intensive Care, Elisabeth-TweeSteden Hospital, Tilburg, Netherlands.
JMIR Res Protoc. 2020 Jun 23;9(6):e16733. doi: 10.2196/16733.
Controlled donation after circulatory death (cDCD) is a major source of organs for transplantation. A potential cDCD donor poses considerable challenges in terms of identification of those dying within the predefined time frame of warm ischemia after withdrawal of life-sustaining treatment (WLST) to circulatory arrest. Several attempts have been made to develop models predicting the time between treatment withdrawal and circulatory arrest. This time window determines whether organ donation can occur and influences the quality of the donated organs. However, the selected patients used for these models were not always restricted to potential cDCD donors (eg, patients with cancer or severe infections were also included). This severely limits the generalizability of those data.
The objectives of this study are the following: (1) to develop a model predicting time to death within 60 minutes in potential cDCD patients; (2) to validate and update previous prediction models on time to death after WLST; (3) to determine timing and patient characteristics that are associated with prognostication and the decision-making process that leads to initiating end-of-life care; (4) to evaluate the impact of timing of family approach on organ donation approval; and (5) to assess the influence of variation in WLST processes on postmortem organ donor potential and actual postmortem organ donors.
In this multicenter observational prospective cohort study, all patients admitted to the intensive care unit of 3 university hospitals and 3 teaching hospitals who met the criteria of the cDCD protocol as defined by the Dutch Transplant Foundation were included. The target of enrolment was set to 400 patients. Previously developed models will be refitted in our data set. To further update previous prediction models, we will apply least absolute shrinkage and selection operator (LASSO) as a tool for efficient variable selection to develop the multivariable logistic regression model.
This protocol was funded in August 2014 by the Dutch Transplant Foundation. We expect to have the results of this study in July 2020. Patient enrolment was completed in July 2018 and data collection was completed in April 2020.
This study will provide a robust multimodal prediction model, based on clinical and physiological parameters, that can predict time to circulatory arrest in cDCD donors. In addition, it will add valuable insight in the process of WLST in cDCD donors and will fill an important knowledge gap in this essential field of health care.
ClinicalTrials.gov NCT04123275; https://clinicaltrials.gov/ct2/show/NCT04123275.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/16733.
心脏死亡后器官捐献（cDCD）是移植器官的主要来源。潜在的cDCD供体在确定那些在撤除维持生命治疗（WLST）至循环停止的预定义热缺血时间范围内死亡的患者方面带来了相当大的挑战。已经进行了几次尝试来开发预测治疗撤除与循环停止之间时间的模型。这个时间窗口决定了是否可以进行器官捐献，并影响所捐献器官的质量。然而，用于这些模型的选定患者并不总是局限于潜在的cDCD供体（例如，还包括患有癌症或严重感染的患者）。这严重限制了这些数据的普遍性。
本研究的目的如下：（1）开发一个预测潜在cDCD患者60分钟内死亡时间的模型；（2）验证和更新先前关于WLST后死亡时间的预测模型；（3）确定与预后以及导致启动临终关怀的决策过程相关的时间和患者特征；（4）评估家属介入时间对器官捐献批准的影响；（5）评估WLST过程变化对死后器官供体潜力和实际死后器官供体的影响。
在这项多中心观察性前瞻性队列研究中，纳入了3所大学医院和3所教学医院重症监护病房收治的所有符合荷兰移植基金会定义的cDCD方案标准的患者。入组目标设定为400名患者。先前开发的模型将在我们的数据集中重新拟合。为了进一步更新先前的预测模型，我们将应用最小绝对收缩和选择算子（LASSO）作为有效变量选择的工具来开发多变量逻辑回归模型。
该方案于2014年8月由荷兰移植基金会资助。我们预计在2020年7月获得本研究的结果。患者入组于2018年7月完成，数据收集于2020年4月完成。
本研究将基于临床和生理参数提供一个强大的多模式预测模型，该模型可以预测cDCD供体的循环停止时间。此外，它将为cDCD供体的WLST过程提供有价值的见解，并将填补这一重要医疗领域的重要知识空白。
ClinicalTrials.gov NCT04123275；https://clinicaltrials.gov/ct2/show/NCT04123275。
国际注册报告识别码（IRRID）：DERR1-10.2196/16733。
