Official Title
Comparative Analysis of Clinical Outcomes and Inflammatory Responses in Viral Versus Bacterial Sepsis: A Retrospective Cohort Study in ICU Patients
Brief Summary

This observational cohort study aims to compare clinical outcomes and inflammatoryresponses between patients with viral sepsis, specifically COVID-19-associated sepsis,and those with bacterial sepsis. Conducted at Sichuan Provincial People's Hospital, thestudy will retrospectively analyze data from ICU patients admitted between July 2021 andDecember 2023. The primary objective is to identify reliable biomarkers and diagnosticmethods to improve patient outcomes through personalized diagnostic and therapeuticstrategies.

Detailed Description

Sepsis, a major cause of morbidity and mortality in ICU patients, has garnered increased
attention during the COVID-19 pandemic due to the high mortality rates associated with
viral sepsis. This study seeks to elucidate the differences in clinical outcomes,
inflammatory responses, and treatment strategies between bacterial and viral sepsis. By
leveraging a comprehensive dataset of ICU patients diagnosed with sepsis at Sichuan
Provincial People's Hospital, the study will retrospectively compare the two sepsis
types.

A total of 267 patients diagnosed according to Sepsis 3.0 criteria, including 105 with
bacterial sepsis and 162 with viral sepsis (COVID-19 confirmed via RT-PCR), will be
included. Key clinical parameters such as mortality rate, length of ICU stay, SOFA
scores, and the need for life support measures (mechanical ventilation, CRRT, ECMO) will
be analyzed. Additionally, the study will examine cytokine profiles and other
inflammatory markers to identify significant differences between the two groups.

The study will utilize advanced statistical methods, including Kaplan-Meier survival
analysis, multinomial logistic regression, and ROC curve analysis, to evaluate the
predictive power of various biomarkers. The findings are expected to highlight critical
factors contributing to the higher mortality observed in viral sepsis and inform the
development of targeted treatment strategies. The ultimate goal is to improve diagnostic
accuracy and patient outcomes through personalized approaches tailored to the type of
sepsis.

Key objectives include understanding the distinct inflammatory responses in bacterial and
viral sepsis and identifying reliable biomarkers for differentiation. The study will also
evaluate the impact of different treatment regimens, particularly antibiotic use, on
clinical outcomes. Insights gained from this research will contribute to the broader
understanding of sepsis management and guide future clinical practice and research.

Recruiting
Sepsis
Sepsis Bacterial
Viral Sepsis
Inflammatory Response
Cytokine Storm
COVID-19
MODS

Other: observation

data collected includes demographic information, clinical outcomes (mortality rate, ICU
stay length), inflammatory markers (e.g., IL-2, IL-10, TNF-α), and treatment details
(mechanical ventilation, CRRT, ECMO, antibiotics). Culture results, NGS findings, and
imaging reports were also documented.

Eligibility Criteria

Inclusion Criteria:

1. Patients diagnosed with sepsis according to Sepsis 3.0 criteria.

2. Patients with confirmed bacterial sepsis based on positive bacterial cultures.

3. Patients with confirmed viral sepsis, specifically COVID-19, diagnosed via RT-PCR
for SARS-CoV-2 for viral group and negative for bacterial group.

4. Patients aged 18 years and older.

5. Patients admitted to the ICU during the study period.

Exclusion Criteria:

1. Patients with mixed bacterial and viral infections.

2. Patients with sepsis not meeting the Sepsis 3.0 criteria.

3. Patients who received immunomodulatory therapies other than standard treatments
(e.g., investigational drugs).

4. Pregnant or breastfeeding women.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 90 Years
Countries
China
Locations

Sichuan Provincial People's Hospital
Chengdu 1815286, Sichuan 1794299, China

Investigator: Lin Chen
Contact: +8618111585286
chenlinhx@med.uestc.edu.cn

Contacts

Lin Chen, doctor
8618111585286
chenlinhx@med.uestc.edu.cn

Lin Chen, doctor, Principal Investigator
Sichuan Provincial People's Hospita

Sichuan Provincial People's Hospital
NCT Number
MeSH Terms
Sepsis
Viremia
Cytokine Release Syndrome
COVID-19
Multiple Organ Failure
Observation