The Effect of Nebulized Albuterol on Donor Oxygenation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 506
- 试验地点
- 1
- 主要终点
- Donor Oxygenation
研究概览
简要总结
The purpose of this study is to test the effectiveness of albuterol versus placebo with the following specific aims: a) Treatment of brain dead organ donors with albuterol will reduce pulmonary edema, improve donor oxygenation, and increase the number of lungs available for transplantation, b) Developing a blood test to predict the development of primary graft dysfunction in lung transplant recipients, and c) treating brain dead organ donors with albuterol will decrease markers of primary graft dysfunction and lead to improved lung transplant recipient outcomes and to higher rates of lungs suitable for transplantation.
详细描述
The donor lung utilization rate in the United States remains less than 15%, and the demand for donor lungs far exceeds the available supply. The most common reasons for failure to utilize donor lungs are donor hypoxemia and/or pulmonary infiltrates. Since pulmonary edema is a common, reversible cause of hypoxemia and infiltrates in patients with brain injury, strategies to treat pulmonary edema in organ donors should lead to improved donor oxygenation and higher rates of donor lung utilization. Inhaled beta-2 agonists increase the rate of alveolar fluid clearance and reduce pulmonary edema in both animal and human lungs. In addition, our group has recently reported that the majority of human donor lungs that are rejected for transplantation have measurable pulmonary edema and respond to beta-2 agonists with increased rates of alveolar fluid clearance. Based on this compelling scientific evidence, we propose to test the efficacy of an inhaled beta-2 agonist to increase the rate of alveolar fluid clearance and reduce pulmonary edema in brain dead organ donors with the following specific aims:
Specific Aim 1: To test the effect of aerosolized albuterol on donor oxygenation in a multicenter, randomized, double-blinded, placebo-controlled trial in 500 brain dead organ donors managed over a 2 year period by the California Transplant Donor Network (CTDN).
Hypothesis 1a: Treatment of brain dead organ donors with aerosolized albuterol will improve donor oxygenation and increase the donor lung utilization rate compared to treatment with placebo.
Hypothesis 1b: Treatment of brain dead organ donors with aerosolized albuterol will reduce the severity of pulmonary edema in procured lungs compared to treatment with placebo.
Specific Aim 2: To develop and validate a panel of biological markers that can predict and diagnose acute lung injury due to primary graft dysfunction in lung transplant recipients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Brain death
- •Consent for lung donation and donor research
- •Release from coroner or medical examiner
- •Exclusion Criteria
- •Age less than 14 years
排除标准
- 未提供
研究组 & 干预措施
Saline
Saline administered every 4 hours by nebulization
干预措施: Saline (Drug)
Albuterol
Albuterol sulfate 5 mg dissolved in normal saline administered every 4 hours by nebulization
干预措施: Albuterol (Drug)
Saline
Saline administered every 4 hours by nebulization
干预措施: Albuterol (Drug)
结局指标
主要结局
Donor Oxygenation
时间窗: Change from enrollment to organ procurement (about ~40h after enrollment)
The primary outcome was the change in oxygenation as measured by change in the PaO2/FiO2 ratio from study enrollment to organ procurement
次要结局
- Lung Compliance(baseline and at organ procurement (about ~40h after enrollment))
- Pulmonary Vascular Resistance(72 hours)
- Number of Donor Lungs Used for Transplantation(72 hours)
- Chest X-ray Findings(change from enrollment to organ procurement (about ~40h after enrollment))
研究者
Lorraine B. Ware
Professor of Medicine
Vanderbilt University Medical Center