Study on Risk Identification Factors for Lung Function Impairment in AIDS Patients Recovered From Severe Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Obstructive Ventilatory Dysfunction
研究概览
简要总结
Screening for risk factors related to lung function impairment in patients who have recovered from AIDS with severe pneumonia, to provide clinical evidence for early identification and intervention of lung function damage in this population.
详细描述
This is a prospective, single-center, non-randomized, clinical observational cohort study. It involves monitoring lung function at discharge (baseline, 0w), and at the 4th, 8th, 12th, 24th, and 48th weeks in patients recovering from severe pneumonia with AIDS. Basic demographic data, HIV RNA quantification, routine blood tests, blood biochemistry, arterial blood gas results, oxygenation index, immune function (CD3+, CD4+, CD8+ T cell counts), and imaging studies are also collected. Multifactorial logistic regression analysis is used to screen for clinical predictors of lung function decline in patients recovering from severe pneumonia
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed HIV infection;
- •Progression to the AIDS stage: CD4+ count <200 cells/µL and/or occurrence of opportunistic infections associated with AIDS;
- •Age between 18 to 65 years;
- •Meet the diagnostic criteria for severe pneumonia, with reference to the 2021 treatment guidelines for community-acquired pneumonia developed by the American Thoracic Society (ATS) and the Infectious Diseases Society of America (IDSA).
排除标准
- •Concurrent central nervous system lesions, severe liver disease, or cirrhosis;
- •Concurrent AIDS-related or non-related tumors;
- •Women who are pregnant or breastfeeding;
- •Presence of serious underlying diseases such as heart, lung, liver, kidney, etc.;
- •Alcohol abuse or drug use;
- •The researcher believes that the overall condition of the subject affects the evaluation and completion of the trial
结局指标
主要结局
Obstructive Ventilatory Dysfunction
时间窗: 12 weeks
FEV1(Forced Expiratory Volume in One Second )to FVC (Forced Vital Capacity ) Ratio
次要结局
- FEV1(12 weeks)
研究者
Linghua LI
Chief physician
Guangzhou 8th People's Hospital