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临床试验/NCT03439995
NCT03439995终止不适用

Goal of Open Lung Ventilation in Donors

Vanderbilt University Medical Center8 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2018年7月9日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
154
试验地点
8
主要终点
Donor lung utilization rate

研究概览

简要总结

The primary goal of this study is to assess whether ventilation of deceased organ donors with an open lung protective ventilatory strategy will improve donor lung utilization rates and donor oxygenation compared to a conventional ventilatory strategy.

详细描述

Deceased organ donors are maintained on life support including mechanical ventilation during the time between brain death and organ procurement. The optimal mode of mechanical ventilation for deceased organ donors has not been definitively established. Since deceased organ donors may develop atelectasis leading to impaired oxygenation, an open lung protective ventilatory strategy with higher positive end expiratory pressure (PEEP), lower tidal volume and recruitment maneuvers has been hypothesized to be beneficial. Favorable outcomes were observed in a European clinical trial comparing open lung protective ventilation (OLPV) to a conventional ventilatory strategy in terms of donor oxygenation and lung utilization for transplantation (Mascia L et al, Journal of the American Medical Association 2010). However, donor management procedures in Europe are much shorter in duration compared to the US and it is not clear that these findings are generalizable to the US donor management environment.

The GOLD trial will test the effect of an OLPV strategy compared to conventional ventilation (CV) in the US donor management environment. This multi center trial will enroll 400 brain dead organ donors randomized into 1 of 2 treatment arms. After randomization, mechanical ventilation will be protocolized according to treatment arm with one arm receiving control ventilation (CV) utilizing standard Donor Network West (DNW) protocols and the other arm receiving the OLPV strategy with higher positive end expiratory pressure (PEEP) and lower tidal volume compared to CV. The primary outcomes is donor lung utilization for transplantation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Outcomes in donors and lung transplant recipients will be done by assessors who are blinded to ventilator treatment assignment

入排标准

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

入选标准

  • Brain death
  • Authorization for research
  • ≥13 years of age

排除标准

  • Arterial/Inspired oxygen ratio (PaO2/FiO2) ≤ 150 mmHg
  • PaO2/FiO2 ≥ 400 mmHg
  • BMI > 40
  • Hepatitis B surface antigen positive
  • Hepatitis C positive
  • Failure to complete donation process
  • Hemodynamic instability

结局指标

主要结局

Donor lung utilization rate

时间窗: during donor management period (usually 12-48 hours)

Percent of donor lungs procured and transplanted into recipient

次要结局

  • Donor lung utilization in likely donors(during donor management period (usually 12-48 hours))
  • Donor oxygenation(during donor management period (usually 12-48 hours))
  • Donor static compliance of the respiratory system(during donor management period (usually 12-48 hours))
  • Donor radiographic atelectasis scoring(during donor management period (usually 12-48 hours))
  • Recipient primary graft dysfunction(72 hours after transplant)
  • Recipient mortality(30 days after transplant)

研究者

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

Lorraine B. Ware

Professor of Medicine

Vanderbilt University Medical Center

研究点 (8)

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