Construction of Special Disease Cohort Database and Biological Sample Holographic Database of Severe Pneumonia

Sponsor
Ruijin Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04882436
Collaborator
(none)
1,000
1
18
55.6

Study Details

Study Description

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
1000 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Construction of Special Disease Cohort Database and Biological Sample Holographic Database of Severe Pneumonia
Actual Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Aug 30, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm Intervention/Treatment
severe pneumonia

Patients with severe pneumonia

Outcome Measures

Primary Outcome Measures

  1. clinical outcome of patients with severe pneumonia [day 3, day 7, day 14, day 30, day 180.]

    The pneumonia is cured or improved, or the treatment of pneumonia is invalid, or the patient is dead.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 >10×109/L or less than 4×109/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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ruijin Hospital, Medical School of Shanghai Jiaotong University Shanghai Shanghai China 200025

Sponsors and Collaborators

  • Ruijin Hospital

Investigators

  • Principal Investigator: Jieming Qu, MD,PhD, Ruijin Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ruijin Hospital
ClinicalTrials.gov Identifier:
NCT04882436
Other Study ID Numbers:
  • SHDC2020CR010-001
First Posted:
May 12, 2021
Last Update Posted:
Oct 11, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 11, 2021