Clinical trial NCT04882436: Construction of Special Disease Cohort Database and Biological Sample Holographic Database of Severe Pneumonia
Official title: Construction of Special Disease Cohort Database and Biological Sample Holographic Database of Severe Pneumonia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Severe Pneumonia
Special Disease Cohort Database
Holographic Library of Biological Samples
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2021-05-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of severe pneumonia

Brief summary: The incidence rate and mortality of lung infection are high worldwide. It is a common and frequently occurring disease which seriously threatens human health. Severe pneumonia accounts for 18-36% of all pneumonia. Severe pneumonia has caused serious economic and medical burden. Therefore, it is urgent to carry out the real-world cohort study of severe pneumonia. Big data and sample library will provide useful clinical guidance and scientific research reserves for clinicians. Through further research, we can improve the treatment success rate and reduce the mortality.

The purpose of this study is to provide reliable biological samples and related data information for the relevant basic and clinical trials in the field of severe pneumonia by carrying out the construction of special disease cohort database and biological sample holographic database, and to establish a long-term sharing platform for the transformation of research results into clinical practice, improve the prognosis of severe pneumonia,and provide the evidence for improving the diagnosis and treatment of severe pneumonia suitable for China's national conditions.


Eligibility criteria: Inclusion Criteria:

* Recent cough, expectoration or aggravation of original respiratory diseases, with or without purulent sputum / chest pain / dyspnea / hemoptysis
* Fever
* Signs of pulmonary consolidation and / or moist rales
* Peripheral blood leukocytes \>10×10\^9/L or less than 4×10\^9/L, with or without nucleus shifting to the left.
* New patchy infiltration, consolidation of lobes / segments, ground glass opacity or interstitial changes, with or without pleural effusion on chest imagings
* Positive etiological examination
* Age \> 18 years old
* Need mechanical ventilation; septic shock need vasoactive drug treatment. Meet one of them.
* ① respiratory rate ≥ 30 beats / min; ② oxygenation index (PaO2 / FiO2) ≤ 250; ③ multilobar infiltration; ④ disturbance of consciousness / disorientation; ⑤ azotemia (BUN ≥ 20mg / dl); ⑥ cytopenia (WBC \< 4.0 × 109 / L); ⑦ thrombocytopenia (platelet \< 10.0 × 109 / L); Ⅷ low body temperature (T \< 36 ℃); Ⅸ hypotension, requiring strong fluid resuscitation. Meet the above three requirements at the same time.

Exclusion Criteria:

● Cannot understand and / or implement the investigation protocol.

Primary outcomes:
measure: clinical outcome of patients with severe pneumonia
timeFrame: day 3, day 7, day 14, day 30, day 180.
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Medical School of Shanghai Jiaotong University
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Jieming Qu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: