Assessment of Trace Elements, Systemic Inflammation and Electrolytes in Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Number of participants with abnormal laboratory test results
研究概览
简要总结
COPD is one of the most common causes of health problems worldwide. It is a disease that is associated with several systemic features that affect its morbidity and mortality.
详细描述
The most prominent features of COPD are systemic inflammation and oxidative stress. There is growing interest in establishing the significance of systemic inflammatory biomarkers in COPD patients, as they could be useful in evaluating exacerbations, monitoring disease progression, and evaluating treatment outcomes.
C-reactive protein (CRP) is a biomarker for systemic inflammation, produced mostly by hepatocytes in response to tissue injury or inflammation.
Tumor necrosis factor - alpha (TNF-α) is a key modulator of the immune system's response to infection. At the sites of inflammation, this cytokine regulates the function of poly-morphs and lymphocytes, with essentially protective benefits for the host. Increased TNF-α production may enhance an injury process locally and also elevated circulating levels may have negative systemic consequences.
Trace elements are hypothesized to play a role in the pathogenesis of many diseases, either directly or indirectly. Trace elements play an important function in the inhibition and activation of enzyme processes .
Zinc, for example, is a co-factor for various enzymes and is important for cell membrane stability, protein synthesis, proper tissue growth, and nucleic acid metabolism.
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 (Participant)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD patients
排除标准
- •Patients with Cardiovascular diseases,
- •diabetes mellitus,
- •chronic kidney disease,
- •chronic liver disease,
- •collagen vascular diseases,
- •currently smoking,
- •current pneumonia or inflammation, or refused to participate in the study
研究组 & 干预措施
COPD patients
It is about 60 patients with Stable COPD
干预措施: Laboratory Tests (Combination Product)
Acute exacerbation COPD
It is about 40 patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD).
干预措施: Laboratory Tests (Combination Product)
healthy controls
It is about 40 healthy controls were included in the study
干预措施: Laboratory Tests (Combination Product)
结局指标
主要结局
Number of participants with abnormal laboratory test results
时间窗: from baseline to 48 hours after the taking blood samle
he study tried to assess some Laboratory Tests in blood and comparing the level of their results in patients with stable and patients with exacerbation of theirs disease and aslo comparing their values between patients who needed and those who did not need mechanical ventilation
Assessment of the pain resulted in COPD
时间窗: from baseline to 72 hours
The Pain was measured by using the visual analogue score (VAS) as Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain
次要结局
未报告次要终点