Ignite Creation Date:
2024-07-17 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06491966
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-07-01
Brief Title:
Clinical Outcomes and Inflammatory Responses in Viral vs Bacterial Sepsis
Sponsor:
Sichuan Provincial Peoples Hospital
Organization:
Sichuan Provincial Peoples Hospital
Study Overview
Official Title:
Comparative Analysis of Clinical Outcomes and Inflammatory Responses in Viral Versus Bacterial Sepsis A Retrospective Cohort Study in ICU Patients
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Peoples 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 Peoples Hospital the study will retrospectively compare the two sepsis types
A total of 267 patients diagnosed according to Sepsis 30 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
A total of 267 patients diagnosed according to Sepsis 30 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None