Clinical Outcomes and Inflammatory Responses in Viral vs. Bacterial Sepsis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorSichuan Provincial People's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with sepsis according to Sepsis 3.0 criteria.
Patients with confirmed bacterial sepsis based on positive bacterial cultures.
Patients with confirmed viral sepsis, specifically COVID-19, diagnosed via RT-PCR for SARS-CoV-2 for viral group and negative for bacterial group.
Patients aged 18 years and older.
Disqualifiers
Patients with mixed bacterial and viral infections.
Patients with sepsis not meeting the Sepsis 3.0 criteria.
Patients who received immunomodulatory therapies other than standard treatments (e.g., investigational drugs).
Pregnant or breastfeeding women.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
observation
Other interventiondata 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.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: viral sepsis group1 intervention
Group B: bacterial sepsis group1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
28 days2
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.
Time frame
From ICU admission until discharge or death, assessed up to 28 daysSecondary outcomes
1
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.
Time frame
baseline (Measured at the time of ICU admission)2
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.
Time frame
Assessed from the time of ICU admission up to 28 days or until discharge or death, whichever came firstSponsors and contacts
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Source ClinicalTrials.gov