Study on Appropriate Technology of Standardized Diagnosis and Treatment for Diabetic Patients With Pulmonary Infections
- Conditions
- Diabetes MellitusPulmonary Infection
- Registration Number
- NCT03617393
- Lead Sponsor
- Ruijin Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 6000
- 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
- Irregular follow-up and lost follow-up
- Withdraw from the study for any reason
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Survival at 30 Days 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 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 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.
- Secondary Outcome Measures
Name Time Method 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 Differences in the time of hospital stay including ordinary sickroom and ICU of patients from different groups.
Sepsis Every 6 months from date of diagnosis of pulmonary infection until the date of death from any cause, assessed up to 3 years Differences in the primary and secondary sepsis after therapy according to guideline from different groups.
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 Differences in confusion, urea, respiratory rate and age 65 scoring system from different groups.
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 Assessment of G test and GM test in order to clarify the diagnosis of fungal infection.
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 Differences of CD3, CD4 and CD8 in different groups in order to research on cell-mediated immunity of patients with or without diabetes and pulmonary infection.
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 Differences in CRP, PCT, IL-6, IL-8, TNF-α from different groups.
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 Assessment latex agglutination test in order to clarify the cryptococcal infection.
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 Differences of IgG, IgA, IgE and IgM in different groups in order to research on cell-mediated immunity of patients with or without diabetes and pulmonary infection.
Trial Locations
- Locations (1)
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China