Clinical Outcomes and Inflammatory Responses in Viral vs. Bacterial Sepsis

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

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

Study Overview

• Status: Recruiting
• Conditions: COVID-19; Sepsis; Inflammatory Response; Cytokine Storm; Sepsis Bacterial; MODS; Viral Sepsis
• Intervention / Treatment: Other: observation

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Lin Chen, doctor; Phone Number: 8618111585286; Email: chenlinhx@med.uestc.edu.cn

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610091
      • Recruiting
      • Sichuan Provincial People's Hospital
      • Contact: Lin Chen; Phone Number: +8618111585286; Email: chenlinhx@med.uestc.edu.cn
      • Contact: Da Jing; Phone Number: +8613547136509; Email: jingda1989@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the ICU of Sichuan Provincial People's Hospital from July 2021 to December 2023 diagnosed with sepsis according to Sepsis 3.0 criteria.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
viral sepsis group; The viral sepsis group comprises patients with sepsis secondary to viral infections, specifically COVID-19. Patients in this group were admitted to the ICU of Sichuan Provincial People's Hospital between July 2021 and December 2023 and diagnosed with viral sepsis based on positive RT-PCR results for SARS-CoV-2.	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.
bacterial sepsis group; The bacterial sepsis group includes patients with sepsis resulting from bacterial infections. These patients were admitted to the ICU of Sichuan Provincial People's Hospital during the same period and diagnosed with bacterial sepsis based on positive bacterial cultures.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality rate	The primary outcome measure is the mortality rate of patients diagnosed with sepsis. This measure will compare the 28-day survival rate in the ICU between patients with bacterial sepsis and those with viral sepsis, specifically COVID-19-associated sepsis.	28 days
Length of ICU stay	This outcome measure will assess the length of ICU stay for patients diagnosed with sepsis. The comparison will be made between bacterial sepsis and viral sepsis patients, considering the duration of ICU admission from the time of diagnosis until discharge or death.	From ICU admission until discharge or death, assessed up to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Levels of key inflammatory markers	This outcome measure will assess the levels of key inflammatory markers, including IL-2, IL-6, IL-8, IL-10, TNF-α, MYD88, mCD64, and nCD64. The comparison will be made between bacterial and viral sepsis patients to identify significant differences in cytokine profiles and their impact on sepsis outcomes.	baseline (Measured at the time of ICU admission)
Incidence of secondary infections	This outcome measure will evaluate the incidence of secondary infections in patients diagnosed with sepsis. The focus will be on identifying the occurrence of secondary bacterial or fungal infections in both bacterial and viral sepsis groups, as well as the impact of these infections on patient outcomes.	Assessed from the time of ICU admission up to 28 days or until discharge or death, whichever came first

Collaborators and Investigators

• Sponsor: Sichuan Provincial People's Hospital
• Investigators: Principal Investigator: Lin Chen, doctor, Sichuan Provincial People's Hospita

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2024
• Primary Completion (Estimated): July 7, 2024
• Study Completion (Estimated): July 10, 2024

Study Registration Dates

• First Submitted: July 1, 2024
• First Submitted That Met QC Criteria: July 8, 2024
• First Posted (Actual): July 9, 2024

Study Record Updates

• Last Update Posted (Actual): July 9, 2024
• Last Update Submitted That Met QC Criteria: July 8, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Sepsis; Toxemia; Cytokine Release Syndrome
• Other Study ID Numbers: SichuanPPHLC03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: At this stage, the decision on whether to make individual participant data (IPD) available to other researchers has not been finalized. Considerations include ethical and privacy concerns, institutional policies, and the potential benefit to the scientific community. If data sharing is implemented in the future, it will comply with relevant regulations and guidelines, ensuring the privacy and confidentiality of the participants. Researchers interested in accessing the IPD may contact the principal investigator for further information and potential collaboration opportunities.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No