Goal of Open Lung Ventilation in Donors
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
- 否
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
Lorraine B. Ware
Professor of Medicine
Vanderbilt University Medical Center
