Clinical trial NCT06491966: Clinical Outcomes and Inflammatory Responses in Viral vs. Bacterial Sepsis
Official title: Comparative Analysis of Clinical Outcomes and Inflammatory Responses in Viral Versus Bacterial Sepsis: A Retrospective Cohort Study in ICU Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Sepsis Bacterial
Viral Sepsis
Inflammatory Response
Cytokine Storm
COVID-19
MODS
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Mortality rate
timeFrame: 28 days
measure: Length of ICU stay
timeFrame: From ICU admission until discharge or death, assessed up to 28 days
Secondary outcomes:
measure: Levels of key inflammatory markers
timeFrame: baseline (Measured at the time of ICU admission)
measure: Incidence of secondary infections
timeFrame: Assessed from the time of ICU admission up to 28 days or until discharge or death, whichever came first
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
Study officials:
affiliation: Sichuan Provincial People's Hospita
name: Lin Chen, doctor
role: PRINCIPAL_INVESTIGATOR
References: