跳至主要内容
临床试验/NCT04123275
NCT04123275已完成不适用

DCD III Study: a Multicentre Prospective Study to Identify Parameters Predicting Time to Death in Controlled Circulatory Death (cDCD) Donors and Prospective Validation of Previous Derived Prediction Models on Time to Death.

Radboud University Medical Center6 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2015年7月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
400
试验地点
6
主要终点
Duration (in minutes) on time to circulatory death after withdrawal of life-sustaining treatment, in cDCD patients

研究概览

简要总结

A considerable number of potential cDCD donors do not convert into actual organ donors because circulatory arrest does not occur within the predefined timeframe of warm ischemia after withdrawal of life-sustaining treatment. The main objective of this study is to determine parameters predicting time to death in potential cDCD patients.

详细描述

Controlled donation after circulatory death (cDCD) is a major source of organs for transplantation. Even though there is a well-established cDCD program in the Netherlands, there is still a considerable number of potential donors not being converted into actual organ donors. A potential cDCD donor poses considerable challenges in terms of a) identification of those dying within the predefined timeframe of warm ischemia, after withdrawal of life-sustaining treatment to circulatory arrest, b) managing them appropriately within the framework and resources of the intensive care unit, c) dealing with family expectations especially when failure to donation occurs, and d) efficient utilization of the organ procurement teams.

Factors associated with early circulatory collapse after treatment withdrawal include a younger age, non-triggered modes of artificial ventilation, high FiO2, the use of inotropes, and a low arterial pH. Another important factor which could influence the donor potential is end-of-life treatment. The practice of withdrawal of life support treatment (WLST) is highly variable between ICU's and countries. This influences the dying process and can thus have a large influence on the onset of cardio respiratory arrest. There is also wide variation in the use and dosage of additional sedation and analgesia during WLST and controversy exists regarding hastening or slowing down death.

Several attempts have been made to develop models to predict the time between treatment withdrawal and circulatory arrest, as this is crucial to a) proceed with organ donation, and b) the quality of the harvested organs. The selected patients however, where not always restricted to potential candidates for cDCD organ donation as patients with cancer and severe infection were also included.

Objective: Objectives of this study are: a) To determine parameters predicting time to death in potential cDCD patients b) To validate and update previous predicting models on time to death after withdrawal of life-sustaining treatment. c) To assess variation in withdrawal of life-sustaining treatment in the Netherlands and its influence on post mortal organ donor potential and actual post mortal organ donors.

Design and setting: Multicenter, observational, prospective cohort study of all potential cDCD patients of 3 university and 3 teaching hospitals in the Netherlands with diverse focus of attention

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
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • mechanically ventilated patients
  • aged between 18 and 75 years old, where further treatment is futile.
  • patients should meet the criteria of potential cDCD donors as defined by the Dutch Transplant Foundation

排除标准

  • non-intubated patients
  • younger than 18 years old
  • brain dead patients

结局指标

主要结局

Duration (in minutes) on time to circulatory death after withdrawal of life-sustaining treatment, in cDCD patients

时间窗: 36 months

Development of a prediction tool to detect time to circulatory death (in minutes) in controlled donation after circulatory death patients (cDCD)

次要结局

  • Incidence of circulatory death in 120 and 180 minutes(36 months)
  • Incidence of withdrawal of endotracheal tube(36 months)
  • Incidence of circulatory death in 60 minutes(36 months)
  • Doses analgesia(36 months)
  • Doses sedation(36 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

Loading locations...

相似试验