Clinical Outcomes and Inflammatory Responses in Viral vs. Bacterial Sepsis

Recruiting

• Conditions: Sepsis; MODS; Inflammatory Response; Viral Sepsis; Cytokine Storm; Sepsis Bacterial; COVID-19
• Interventions: Other: observation

• Registration Number: NCT06491966
• Lead Sponsor: Sichuan Provincial People's Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2024-04-02
• Status Verified: 2024-07
• Study First Submitted: 2024-07-01
• Primary Completion: 2024-07-07
• Study First Submitted QC: 2024-07-08
• Last Update Submitted: 2024-07-08
• Study First Posted: 2024-07-09
• Last Update Posted: 2024-07-09
• Study Completion: 2024-07-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
viral sepsis group	observation	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.
bacterial sepsis group	observation	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.

Primary Outcome Measures

Name	Time	Method
Length of ICU stay	From ICU admission until discharge or death, assessed up to 28 days	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.
Mortality rate	28 days	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of secondary infections	Assessed from the time of ICU admission up to 28 days or until discharge or death, whichever came first	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.
Levels of key inflammatory markers	baseline (Measured at the time of ICU admission)	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.

Trial Locations

Locations (1)

Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, Sichuan, China