A Clinical Study to Determine if Nebulized Hypertonic Saline Attenuates Acute Lung Injury Following Trauma and Hemorrhagic Shock
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- change in the respiratory parameters
研究概览
简要总结
This study evaluates the use of nebulized hypertonic saline (aerosolized salt water) as a preventive treatment for post-traumatic acute lung injury (ALI). Both animal and human research indicate that aerosolized salt water might help reduce harmful inflammation with minimal risks.
详细描述
Despite over 40 years of investigation, acute lung injury (ALI) remains a leading cause of morbidity in critically ill patients, and a disease for which there is no effective pharmacologic therapy. Our group and others have focused on the anti-inflammatory effects of intravenous hypertonic saline (HTS) acting on the injured endothelium with promising results experimentally, but failed to confirm the benefit clinically. Recent work, however, has shown that inhaled or nebulized HTS targeted at the epithelium is safe and effective in treating cystic fibrosis, COPD, and neonatal bronchiolitis. Recognizing the central role of the pulmonary epithelium in ALI, nebulization has the advantage of achieving high concentrations of the therapy without producing systemic side effects. Thus, we hypothesize that nebulized hypertonic saline will attenuate acute lung injury following trauma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult 18 ≤ age ≤ 65
- •trauma with a 9 ≤ NISS ≤ 36
- •≤10 units of RBC in the first 6 hours (as this is a major risk factor for ARDS and MOF in this population)
排除标准
- •Direct or indirect lung injury
- •Elevated intracranial pressure requiring treatment, including but not limited to mannitol, intravenous hypertonic saline, and ventricular drainage
- •History of severe chronic respiratory disease
- •Child-Pugh Class C liver failure
- •Prisoners
- •Pregnant women
研究组 & 干预措施
Nebulized HTS
The first 5 patients will receive 3% Nebulized hypertonic saline, the second 5 patients will receive 4.5% Nebulized hypertonic saline, the third group 6% Nebulized hypertonic saline, and the fourth group of 5 patients will receive 7% Nebulized hypertonic saline. The nebulizer is dosed 2-3 times a day for 36 hours.
干预措施: Nebulized hypertonic saline (Drug)
结局指标
主要结局
change in the respiratory parameters
时间窗: baseline and every 6 hours for 36 hours
For intubated patients - A decrease greater than 20% in PaO2/FiO2 (P/F) ratios will trigger DSMB review. For not intubated patients - a) the need to increase FiO2 by 10% (approximate 4 liter/minute increase) to maintain a peripheral oxygen saturation (SaO2) of 90% during nebulizer treatment; b) evidence of respiratory distress (as documented in the chart by the patient's attending) during nebulizer treatment; and c) respiratory insufficiency requiring intubation and mechanical ventilation at any point will trigger DSMB review.
次要结局
- death within 28 days(28 days or discharge)
- lung dysfunction scores(baseline and 28 days or discharge)
- ventilator-free days (VFD)(baseline and 28 days or discharge)
- MOF scores (Denver MOF score)(28 days or discharge)
研究者
Ernest E. Moore, MD
Professor of Surgery
Denver Health and Hospital Authority