Clinical Outcomes and Inflammatory Responses in Viral vs. Bacterial Sepsis

NCT06491966 | Recruiting

• 1 other identifier: SichuanPPHLC03
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Levels of key inflammatory markers

  baseline (Measured at the time of ICU admission)

• Incidence of secondary infections

  Assessed from the time of ICU admission up to 28 days or until discharge or death, whichever came first

Study Arms (2)

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

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

Interventions

observation OTHER

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; viral sepsis group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• Patients admitted to the ICU during the study period.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead

Study Sites (1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610091, China

RECRUITING

Related Publications (1)

• Xiong L, Tang H, Xie Q, Fang H, Jing D, Chen L. Immune Signatures Distinguish Pure and Mixed Sepsis in Critical COVID-19: A Retrospective Cohort Study. J Inflamm Res. 2025 Aug 14;18:11139-11153. doi: 10.2147/JIR.S531962. eCollection 2025.

  PMID: 40831520 DERIVED

MeSH Terms

Conditions

Sepsis; Viremia; Cytokine Release Syndrome; COVID-19; Multiple Organ Failure

Interventions

Observation

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Virus Diseases; Shock; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Lin Chen, doctor

  Sichuan Provincial People's Hospita

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Chen, doctor

CONTACT

8618111585286; chenlinhx@med.uestc.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 9, 2024
• Study Start: April 2, 2024
• Primary Completion: July 7, 2024
• Study Completion: July 10, 2024
• Last Updated: July 9, 2024

Record last verified: 2024-07

Locations

CN (1)