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NCT Number: NCT06491966

Clinical Outcomes and Inflammatory Responses in Viral vs. Bacterial Sepsis

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Mortality rate

    Time frame: 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.

  2. Length of ICU stay

    Time frame: 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.

Secondary outcomes

  1. Levels of key inflammatory markers

    Time frame: 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.

  2. Incidence of secondary infections

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lin Chen, doctor

CONTACT

[email protected]

8618111585286

Sponsors and collaborators

Lead sponsor

Sichuan Provincial People's Hospital

Other

Registry information

Official study title

Comparative Analysis of Clinical Outcomes and Inflammatory Responses in Viral Versus Bacterial Sepsis: A Retrospective Cohort Study in ICU Patients

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 9, 2024
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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