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临床试验/NCT02430961
NCT02430961Unknown不适用

Predictors of Apnea and Prediction of Time to Death in Donation After Cardiac Death

University Health Network, Toronto0 个研究点目标入组 158 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
158
主要终点
Death (at 120 minutes)

研究概览

简要总结

Donation after Cardiac Death (DCD) is an increasingly common mechanism through wish patients can donate tissue and organs following death after withdrawal of life sustaining therapies (WLST). Unfortunately many potential DCD donors are not ultimately able to donate and this is a significant emotional and resource burden to families, healthcare workers and hospitals. A tool that allows accurate prediction of time to death following WLST (and thus the probability of successful donation) is urgently needed. Existing models have not been useful due to the lack of generalizability. Additionally, existing models have not included other important factors now recognized to be associated with time to death following WLST.

The investigators will conduct a prospective, observational cohort study of all patients being considered for DCD in whom consent for donation is obtained to evaluate the association between neurologic and non-neurologic risk factors for apnea, other clinically important variables and time to death after WLST, and use these data to derive a generalizable predictive model for the prediction of the time to death following WLST in potential DCD donors.

详细描述

Donation after cardiac death (DCD) is a method by which patients have the opportunity to donate organs following elective withdrawal of life-sustaining therapies (WLST). Often these patients have suffered a catastrophic neurological injury although not progressed to brain death or have a severe medical condition for which ongoing medical care is considered non-beneficial. DCD has become an increasingly significant source of organs for transplantation in a time of growing wait lists and organ shortfall.

In order to donate organs through DCD, the potential donor must progress to death within a certain time window after withdrawal of life sustaining therapies. This timeframe varied but is usually less than 120 minutes following WLST. Up to 40% of potentially eligible DCD donors in Ontario do not proceed to organ procurement for these reasons (internal data from Trillium Gift of Life).

The uncertainty and variability in the potential for successful organ procurement has an impact on families, health care teams and organ retrieval teams. It is important that this emotional and resource burden only occurs in candidates with a reasonable likelihood of being eligible to donate organs. The amount of time elapsing between WLST and circulatory arrest (and organ procurement) has important implications for the quality of the procured organs, and some organs are unable to be transplanted after death. Finally, maintaining organ procurement teams and an operating room on standby consumes valuable hospital resources and removes these human and physical resources from other clinical duties.

Several different prediction tools have been proposed to predict time to death following WLST in potential DCD donors, but none has been proven useful. To derive a more generalizable prediction tool it is necessary to identify valid predictors that are common to a wide variety of patients undergoing WLST. We propose the addition of features that predict apnea or respiratory insufficiency in the development of a new predictive model.

While previous studies propose important variables for prediction of time to death, we hypothesize that features that are focused on apnea (neurologic and non-neurologic) will be independently predictive of time of death following WLST.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Planned withdrawal of life sustaining therapy
  • Deemed eligible for DCD by Trillium Gift of Life
  • Signed consent for DCD following withdrawal of life sustaining therapy

排除标准

  • Refusal to or withdrawal of consent to DCD
  • Patients in whom organs are deemed unsuitable for donation prior to withdrawal of life sustaining therapy

结局指标

主要结局

Death (at 120 minutes)

时间窗: 120 minutes following withdrawal of life sustaining therapy

The primary outcome is death within 120 minutes of WLST. Time to death is defined as the period from the initiation of withdrawal of life supportive therapies and the declaration of death (inclusive of waiting period following circulatory arrest).

次要结局

  • Death (at 60 minutes)(60 minutes following withdrawal of life sustaining therapy)
  • Death (at 30 minutes)(30 minutes following withdrawal of life sustaining therapy)
  • Warm Ischemic Time(120 minutes following withdrawal of life sustaining therapy)
  • Number and Type of Organs procured(24 hours following withdrawal of life sustaining therapy)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeffrey M Singh, MD

Site Director, Critical Care, Toronto Western Hospital and Assistant Professor, University of Toronto

University Health Network, Toronto

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