Clinical Outcomes and Inflammatory Responses in Viral vs. Bacterial Sepsis

Sichuan Provincial People's Hospital

Status: Enrolling

Conditions: COVID-19; MODS; Cytokine Storm; Inflammatory Response; Viral Sepsis; Sepsis Bacterial; Sepsis

Treatments: Other: observation

Study type: Observational

Funder types: Other

Identifiers

NCT06491966

SichuanPPHLC03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 2 patient groups

viral sepsis group

Description:

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.

Treatment:

Other: observation

bacterial sepsis group

Description:

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.

Treatment:

Other: observation