A Prospective Observational Cohort Study Protocol for Disease Severity Stratification and Prognosis Assessment in Patients With Pneumonia
研究概览
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Liang Peng, Doctor
- 电话号码:86-020-85959142
- 邮箱:pl_206@126.com
学习地点
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Guangdong
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Guangzhou、Guangdong、中国
- Fifth Affiliated Hospital of Guangzhou Medical University
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接触:
- Liang Peng, Doctor
- 电话号码:86-020-85959142
- 邮箱:pl_206@126.com
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion and Exclusion Criteria for Pneumonia Patients 1.1 Inclusion Criteria 1) Age ≥ 18 years old; 2) Meeting the diagnostic criteria for pneumonia (acute onset + new infiltrates on imaging); 3) Time from onset to admission ≤ 72 hours; 4) Signed written informed consent. 1.1.1 Inclusion Criteria for Severe Pneumonia Patients A diagnosis of "severe pneumonia" can be made if one of the main criteria or ≥ 3 of the secondary criteria are met.
Main Criteria:
① Requires mechanical ventilation with tracheal intubation
② Requires vasopressor drugs after aggressive fluid resuscitation for septic shock
Secondary Criteria:
Respiratory rate ≥ 30 breaths/min
PaO₂/FiO₂ ≤ 250 mm Hg
Multiple lobe infiltrates
Confusion and/or disorientation
⑤ Blood urea nitrogen ≥ 20 mg/dL
⑥ Leukopenia (WBC < 4×10⁹/L)
⑦ Thrombocytopenia (PLT < 100×10⁹/L)
⑧ Decreased body temperature (central body temperature < 36 ℃)
⑨ Hypotension requiring fluid resuscitation 1.2 Exclusion Criteria
- End-stage diseases (such as expected survival < 48 hours);
- Long-term immunosuppressive therapy (prednisone > 20mg/d for more than 3 weeks, or neutropenia after chemotherapy);
- Pregnant or lactating women. 2. Inclusion and Exclusion Criteria for Patients with Suspected Infection but Negative Pathogen Testing 2.1 Inclusion Criteria
- Age ≥ 18 years old;
- Having infection-related symptoms or signs (such as fever, cough, sputum production, elevated white blood cells, etc.), clinically suspected of pneumonia;
- All pathogen tests are negative within 3 days after admission;
- Time from onset to admission ≤ 72 hours;
- Signed written informed consent. 2.2 Exclusion Criteria
- End-stage diseases (such as expected survival < 48 hours);
- Long-term immunosuppressive therapy;
- Pregnant or lactating women;
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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肺炎
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Severe pneumonia
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Non-infection control group
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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28-day all-cause mortality
大体时间:28-day period following enrollment
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28-day period following enrollment
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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The incidence rate of patients in the non-severe group progressing to severe condition
大体时间:28-day period following enrollment
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28-day period following enrollment
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Time taken for the non-severe group to progress to the severe stage
大体时间:28-day period following enrollment
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28-day period following enrollment
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Duration of ICU stay
大体时间:28-day period following enrollment
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28-day period following enrollment
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Duration of mechanical ventilation
大体时间:28-day period following enrollment
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28-day period following enrollment
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Total hospitalization days
大体时间:28-day period following enrollment
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28-day period following enrollment
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28-day readmission rate
大体时间:28-day period following enrollment
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28-day period following enrollment
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其他结果措施
结果测量 |
大体时间 |
|---|---|
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Multimodal omics analysis
大体时间:Day 0
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Day 0
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合作者和调查者
调查人员
- 学习椅:Zifeng Yang, Doctor、The First Affiliated Hospital of Guangzhou Medical University
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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