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临床试验/NCT04710849
NCT04710849Unknown不适用

Relationship Between Plasma Metabolome and the Efficacy of Systemic Glucocorticoid in Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Metabolic markers related to systemic glucocorticoid therapy

研究概览

简要总结

Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) significantly increases the mortality of the patients with COPD. Guidelines have recommended systemic glucocorticoid as regular treatment. Recently, evidences have shown that systemic glucocorticoid cannot not be benefit to all of the patients with AECOPD. Thus the problem that how the clinicians can screen the patients who can benefit from systemic glucocorticoid needs to be solved urgently.

详细描述

Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) significantly increases the mortality of the patients with COPD. Guidelines have recommended systemic glucocorticoid as regular treatment. Recently, evidences have shown that systemic glucocorticoid cannot not be benefit to all of the patients with AECOPD. Thus the problem that how the clinicians can screen the patients who can benefit from systemic glucocorticoid needs to be solved urgently. A previous study found that plasma metabolome changed significantly after dexamethasone treatment in health participants. Furthermore, inter-person variability was high and remained uninfluenced by treatment, suggesting the potential of metabolomics for predicting the efficacy and side effects of systemic glucocorticoid. Our previous study found that serum metabolites profile in COPD patients differed from that in controls. Therefore, the investigators hypothesized that metabolome changes in patients with AECOPD may be associated with the efficacy of systemic glucocorticoid. In this study, the investigators will utilize ultraperformance liquid chromatography / mass spectrometry (LC-MS) and gas chromatography / mass spectrometry (GC-MS) methods for analysis of the metabolites in AECOPD patients and compare the metabolites profiles between patients with systemic glucocorticoid treatment success and treatment failure. The investigators aim to detect the metabolic biomarkers and metabolic pathways which are related to efficacy of systemic glucocorticoid and contribute to the precise treatment of COPD.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who meet the diagnostic criteria for acute exacerbation of chronic obstructive pulmonary disease in GOLD 2016 and require hospitalization.

排除标准

  • Bronchial asthma, bronchiectasis and other airflow obstructive diseases;
  • Combined with community-acquired pneumonia, hospital-acquired pneumonia or aspiration pneumonia;
  • Combined with severe liver and kidney insufficiency;
  • Malignant tumor;
  • Immune deficiency due to chemotherapy or HIV infection;
  • Received systemic hormone therapy due to acute exacerbation of chronic obstructive pulmonary disease within 1 month before this admission;
  • Severe trauma or stress, etc.

结局指标

主要结局

Metabolic markers related to systemic glucocorticoid therapy

时间窗: 1 year

Through metabolomics research methods such as liquid chromatography-mass spectrometry and gas chromatography-mass spectrometry, study the metabolic marker group profile of patients with acute exacerbation of COPD before receiving systemic glucocorticoid therapy, and look for possible systemic metabolic markers related to the short-term and long-term effects of glucocorticoids.

次要结局

  • Mortality within 1 year(1 year)
  • Length of hospital stay(1 year)
  • Time from discharge to the next exacerbation(1 year)
  • Side effects of glucocorticoid therapy(1 year)
  • Acute exacerbation frequency(1 year)
  • mMRC score(1 year)
  • CAT score(1 year)
  • Changes in pulmonary function(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

li qiuyu

Attending Doctor of Department of Respiratory and Critical Care Medicine

Peking University Third Hospital

研究点 (1)

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