Modulation of Lung Injury Complicating Lung Resection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Post-operative Plasma IL-6
研究概览
简要总结
The purpose of this study is to determine whether N-acetylcysteine given intravenously 1 day pre-operatively is effective in preventing inflammation in the lungs, as measured by tests on blood, breath and lung specimens, in patients undergoing surgery to remove a portion of lung.
详细描述
Acute lung injury occurs following lung resection in about 5% cases, and has a high mortality of around 50%. Management of these patients is largely supportive. Even in patients who do not develop clinical evidence of acute lung injury, markers of inflammation and oxidative stress are present in blood and exhaled breath condensate after lung resection. The purpose of this randomised double-blind placebo-controlled study is to determine whether lung injury can be prevented by pre-administration of N-acetylcysteine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective lung resection for cancer
排除标准
- •Age less than 18 years
- •Women of child-bearing age or potential
- •Known allergy to N-acetylcysteine
- •Oral steroid in the preceding 1 month
- •N-acetylcysteine in the preceding 1 month
- •Unable to receive standardised anaesthetic approach
研究组 & 干预措施
N-acetylcysteine
Participant received N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively
干预措施: N-acetylcysteine (Drug)
Placebo
Participant received 0.9% saline 1 litre intravenous over 12 hours pre-operatively
干预措施: 0.9% saline (Drug)
结局指标
主要结局
Post-operative Plasma IL-6
时间窗: Post operative, 24 hours
Plasma IL-6 was measured in duplicate using ELISA.
次要结局
未报告次要终点