Substudy: Oxygen Therapy in COPD Patients - Oxidative Stress and Mortality
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Oxidative stress levels (systemic and lung 8-isopropane levels).
研究概览
简要总结
As protocol NCT04223050. This substudy furthermore investigates the role of oxidative stress in the administration of oxygen in COPD patients.
详细描述
Studies have shown that oxidative stress plays a critical role in the pathogenesis of COPD and its comorbidities. Oxidative stress refers to a state in which the activity of oxidants (e.g. reactive oxygen species (ROS)) outweighs that of antioxidants. ROS can be introduced exogenously by for example cigarette smoke and atmospheric pollution, but is also produced endogenously as a byproduct of ATP production in mitochondria or from immune cells during oxidative burst. When high fractions of inspired oxygen are administered, excess O2 can lead to formation of additional ROS, which depletes antioxidants and induces an inflammation with leukocyte-derived inflammatory mediators migrating to the site of injury. In turn, this causes cellular hypertrophy, increased surfactant secretion, and cellular influx of monocytes and mast cells. During the final, fibrotic phase of oxygen toxicity, irreversible, persistent destruction of the pulmonary lining have occurred with collagen disposition, thickening of pulmonary interstitial space, and fibrosis.
This substudy therefore aim to investigate the relation between oxygen therapy in COPD patients admitted with acute exacerbation, oxidative stress, and mortality.
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
- None
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
- •age 18 years or older
- •ability to give informed consent
- •previously diagnosed COPD (either confirmed diagnosis at prior hospital - contact or from their general practitioner or confirmed diagnosis by the treating physician in the emergency department (verified by use of relevant medication))
- •admitted with acute exacerbation (acute and worsened shortness of breath) of COPD
- •requiring oxygen treatment
排除标准
- •Instability at arrival requiring immediate lifesaving treatment, e.g. intubation or non-invasive ventilation, within the first 30 minutes
- •Expected total length of stay in hospital < 12 hours
- •Planned transfer to another hospital within 12 hours
- •Unwilling to have repeated arterial blood gas analyses within the first 12 hours
- •Patients judged terminal by treating physician in the emergency department
- •Non-residents of the particular country
- •Expected impossible follow-up
- •Fertile women (<50 years of age) with positive urine human gonadotropin (hCG) or plasma-hCG
- •Prior participation in the study
研究组 & 干预措施
High oxygen saturation
Peripheral oxygen saturation level >94% Intervention: Drug: Oxygen gas
干预措施: Oxygen (Drug)
Low oxygen saturation
Peripheral oxygen saturation level 88-92% Intervention: Drug: Oxygen gas
干预措施: Oxygen (Drug)
结局指标
主要结局
Oxidative stress levels (systemic and lung 8-isopropane levels).
时间窗: Immediately after study completion
次要结局
- Inflammation levels (systemic and lung IL-8 levels)(Immediately after study completion)
- 7-day all-cause mortality and 30-day all-cause mortality(30 days)
- over-all length of hospital stay(Immediately after study completion)
- respiratory acidosis(Immediately after the procedure)
研究者
Mikkel Brabrand
Professor, ph.d., MD
Esbjerg Hospital - University Hospital of Southern Denmark