Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06538441
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Dynamic Pattern of Etiology Immunoinflammatory Factors and Their Association With Prognosis of Severe Pneumonia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Dynamic Pattern of Etiology Immunoinflammatory Factors and Their Association With Prognosis of Severe Pneumonia a Longitudinal Observational Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this longitudinal observational study is to investigate the pathogen spectrum composition of severe pneumonia SP in different disease stages and to study the changes of immune inflammatory factors in patients with SP in different course of disease during and after the COVID-19 pandemic The main questions it aims to answer is
What is the pathogenic profile of SP patient admitted in intensive care unit ICU during and after COVID-19 pandemic What is the dynamic pattern of etiology and immunoinflammatory factors of SP progression during the period in ICU Are those indexes mentioned above associated with the prognosis of SP
What is the pathogenic profile of SP patient admitted in intensive care unit ICU during and after COVID-19 pandemic What is the dynamic pattern of etiology and immunoinflammatory factors of SP progression during the period in ICU Are those indexes mentioned above associated with the prognosis of SP
Detailed Description:
This is a multi-center longitudinal observational study
Participants
SP patients will be continuously recruited in ICU department in Shanghai General Hospital and respiratory-specific ICU RICU department in the First Affiliated Hospital of Chongqing Medical University during June 1 2022 to December 31 2024
The investigators applied the AmericanThoracic SocietyATSInfectious Diseases Society of America IDSA major criteria to a cohort of patients hospitalized in two tertiary hospitals with severe pneumonia in order to describe its epidemiology microbiology and outcomes
Assessment of disease progression
1 Shock Definition A systemic pathological process in which the effective circulating blood volume is reduced due to various reasons and the tissue microcirculation perfusion is seriously insufficient resulting in cell damage and serious dysfunction of function and metabolism of important organs Overall arterial pressure decline systolic blood pressure less than 90mmHg or mean arterial pressure MAP less than 70mmHg accompanied by tachycardia Clinical signs of hypoperfusion skin damp cold with vasoconstriction and cyanosis Kidney urine volume is less than 05mlkgh The nervous system includes changes in mind dullness of reaction loss of orientation and confusion Hyperlactacidemia greater than 2mmolL
2 Invasive mechanical ventilation 1 Definition Support of ventilation and improvement of oxygenation by inserting an intubation tube into the trachea and delivering warm fully oxygenated and moist gases to the airways and lungs at pressures above atmospheric pressure 2 Classification invasive ventilator-assisted ventilation under tracheal intubation invasive ventilator-assisted ventilation under tracheal incision
3 High fever body temperature armpit temperature exceeds 39 C Note High fever is generally defined at 385 in clinical practice
4 The above symptoms persist shock for more than 3 days high fever for more than 3 days mechanical ventilation for more than 1 week
Indicators
1 Sociodemographic indexes sex age personal history
2 Clinical indicators clinical diagnosis past history present history treatment history laboratory examination clinical prognosis
3 Laboratory examination culture species of infectious agent antibiotic susceptibility test Microbiological etiological identification methods include ① oral and pharyngeal swabs polymerase chain reaction PCR for COVID-19 nucleic acid ② Nasopharyngeal swab PCR for influenza A virus nucleic acid ③ Rectal swab Macconkey plate drug-sensitive paper was used to detect the presence of carbapenem-resistant gram-negative bacillus and loop-mediated isothermal amplification was used to identify the presence of IPM VIM NDM KPC OXA and other resistance genes ④ Smear Various specimens are diluted and stained to observe whether there are bacteria and fungi and their morphology ⑤ Culture microbial culture of various specimens and drug sensitivity test to determine drug resistance ⑥ Quick test Rapid detection of infectious diseases including 17 bacteria and 7 fungi ⑦ Immunofluorescence staining Use fluorescein to label fungal cell wall observe fungal morphology under fluorescence microscope for qualitative detection ⑧ Next generation sequencing NGS
Other laboratory tests Blood routine white blood cell count neutrophil count lymphocyte count and neutrophil-to-lymphocyte ratio NLR C-reactive protein CRP procalcitonin PCT
Participants
SP patients will be continuously recruited in ICU department in Shanghai General Hospital and respiratory-specific ICU RICU department in the First Affiliated Hospital of Chongqing Medical University during June 1 2022 to December 31 2024
The investigators applied the AmericanThoracic SocietyATSInfectious Diseases Society of America IDSA major criteria to a cohort of patients hospitalized in two tertiary hospitals with severe pneumonia in order to describe its epidemiology microbiology and outcomes
Assessment of disease progression
1 Shock Definition A systemic pathological process in which the effective circulating blood volume is reduced due to various reasons and the tissue microcirculation perfusion is seriously insufficient resulting in cell damage and serious dysfunction of function and metabolism of important organs Overall arterial pressure decline systolic blood pressure less than 90mmHg or mean arterial pressure MAP less than 70mmHg accompanied by tachycardia Clinical signs of hypoperfusion skin damp cold with vasoconstriction and cyanosis Kidney urine volume is less than 05mlkgh The nervous system includes changes in mind dullness of reaction loss of orientation and confusion Hyperlactacidemia greater than 2mmolL
2 Invasive mechanical ventilation 1 Definition Support of ventilation and improvement of oxygenation by inserting an intubation tube into the trachea and delivering warm fully oxygenated and moist gases to the airways and lungs at pressures above atmospheric pressure 2 Classification invasive ventilator-assisted ventilation under tracheal intubation invasive ventilator-assisted ventilation under tracheal incision
3 High fever body temperature armpit temperature exceeds 39 C Note High fever is generally defined at 385 in clinical practice
4 The above symptoms persist shock for more than 3 days high fever for more than 3 days mechanical ventilation for more than 1 week
Indicators
1 Sociodemographic indexes sex age personal history
2 Clinical indicators clinical diagnosis past history present history treatment history laboratory examination clinical prognosis
3 Laboratory examination culture species of infectious agent antibiotic susceptibility test Microbiological etiological identification methods include ① oral and pharyngeal swabs polymerase chain reaction PCR for COVID-19 nucleic acid ② Nasopharyngeal swab PCR for influenza A virus nucleic acid ③ Rectal swab Macconkey plate drug-sensitive paper was used to detect the presence of carbapenem-resistant gram-negative bacillus and loop-mediated isothermal amplification was used to identify the presence of IPM VIM NDM KPC OXA and other resistance genes ④ Smear Various specimens are diluted and stained to observe whether there are bacteria and fungi and their morphology ⑤ Culture microbial culture of various specimens and drug sensitivity test to determine drug resistance ⑥ Quick test Rapid detection of infectious diseases including 17 bacteria and 7 fungi ⑦ Immunofluorescence staining Use fluorescein to label fungal cell wall observe fungal morphology under fluorescence microscope for qualitative detection ⑧ Next generation sequencing NGS
Other laboratory tests Blood routine white blood cell count neutrophil count lymphocyte count and neutrophil-to-lymphocyte ratio NLR C-reactive protein CRP procalcitonin PCT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None