A Prospective Study of Appropriate Technology of Standardized Diagnosis and Treatment for Diabetic Patients With Complication of Pulmonary Infection
试验速览
- 阶段
- 不适用
- 入组人数
- 6,000
- 试验地点
- 1
- 主要终点
- Survival at 30 Days
研究概览
简要总结
Focusing on patients with diabetes complicated with pulmonary infection, the purpose of this study is: 1) to identify the epidemiology, etiologic spectrum and status of diagnosis and treatment; 2) to develop a symptom score scale , clarify the risk factors and create a precise warning model; 3) to develop a rapid detection of pathogen of lower respiratory infection, to establish clinical pathways of early diagnosis and treatment of diabetes complicated with pulmonary infections (including bacterial, tuberculosis and fungal infections) and then make an application in clinic.
详细描述
Investigators perform a observational study on 6000 patients with diabetes, among which 200 patients with pulmonary infection are included in a retrospective study and 100 patients go through metabolomics research. All patients receive clinical questionnaires, laboratory examinations and pulmonary function tests. Investigators study on pathogen distribution and infection ratio of patients above depending on follow-up survey. 1:1 nested case-control study is carried out involving 100 cases from pulmonary-infected group paired with 100 control cases matched for gender, age and fasting blood-glucose. The final purpose is to create a precise warning model in order to develop a rapid detection of pathogen of lower respiratory infection in diabetes patients. Now investigators wish to register this study to do a further research, in order to improve the early diagnosis of diabetes complicated with pulmonary infection and to reduce the mortality.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis by pathogen examination: positive
- •Diagnosis through X-ray or CT: characteristic features of pulmonary infection
- •Diagnosis through guideline of diabetes or history of diagnosed diabetes
- •Age 40-70 years
排除标准
- •Irregular follow-up and lost follow-up
- •Withdraw from the study for any reason
结局指标
主要结局
Survival at 30 Days
时间窗: 30 days from date of diagnosis of pulmonary infection until the date of death from any cause.
Accuracy and sensitivity of novel survival prediction algorithm derived from differences between the predicted and actual 30-day-survival of patients from different groups.
Survival at 90 Days
时间窗: 90 days from date of diagnosis of pulmonary infection until the date of death from any cause.
Accuracy and sensitivity of novel survival prediction algorithm derived from differences between the predicted and actual 90-day-survival of patients from different groups.
Survival at 1 Year
时间窗: 1 year from date of diagnosis of pulmonary infection until the date of death from any cause.
Accuracy and sensitivity of novel survival prediction algorithm derived from differences between the predicted and actual 1-year-survival of patients from different groups.
次要结局
- Hospitalization Time(Every 6 months from date of diagnosis of pulmonary infection until the date of death from any cause, assessed up to 3 years)
- Sepsis(Every 6 months from date of diagnosis of pulmonary infection until the date of death from any cause, assessed up to 3 years)
- CURB-65 Score(Every 6 months from date of diagnosis of pulmonary infection until the date of death from any cause, assessed up to 3 years)
- Fungal Infection Examinations(Day 0, day 3, day 10-14 and final result from date of diagnosis of pulmonary infection until the date of death or cure from any cause, assessed up to 1 years)
- Cell-mediated Immunoserologic Indexs(Day 0, day 3, day 10-14 and final result from date of diagnosis of pulmonary infection until the date of death or cure from any cause, assessed up to 1 years)
- Inflammatory Parameters(Day 0, day 3, day 10-14 and final result from date of diagnosis of pulmonary infection until the date of death or cure from any cause, assessed up to 1 years)
- Cryptococcal Infection Examinations(Day 0, day 3, day 10-14 and final result from date of diagnosis of pulmonary infection until the date of death or cure from any cause, assessed up to 1 years)
- Humoral Immunoserologic Indexes(Day 0, day 3, day 10-14 and final result from date of diagnosis of pulmonary infection until the date of death or cure from any cause, assessed up to 1 years)
研究者
ZHOU Min
Chief Physician of Department of Respiratory Medicine
Ruijin Hospital