Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06541600
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-05-06
Brief Title:
Risk Factors for Adverse Outcomes in Sepsis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Risk Factors for Adverse Outcomes in Sepsis a Multi-omics Exploration Based on Clinical Cohort Studies
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will adopt a retrospective clinical cohort design and include a certain scale of sepsis patients as research objects to find the risk factors for adverse outcomes in patients with sepsis Bioinformatics techniques were used to infer potential differential genes corresponding to different risk factors Finally through the biobank the investigators established in the past biological samples of patients with sepsis were extracted and protein expression in the samples was detected to comprehensively analyze biological information at multiple levels
Detailed Description:
This study was designed as a retrospective single-center clinical study By searching sepsis patients on the Tongji Cloud platform the investigators will collect clinical data of patients diagnosed with sepsis from 2003 to 2023 and conduct statistical analysis In terms of clinical data the investigators will record the patients basic information medical history clinical symptoms laboratory results etc The main risk factors for adverse clinical outcomes in patients with sepsis were deduced Through GEO database GENE EXPRESSION OMNIBUS bioinformation technology was used to identify the differential genes corresponding to risk factors Finally blood samples from sepsis patients were extracted using the biologic specimen bank built by our department of Critical Care Medicine ethical approval number NoTJ-IRB20150318 to verify the differential genes from the protein level
Study population
This study will select a certain scale of sepsis patients as the study population in order to study the risk factors of adverse outcomes of sepsis from multiple dimensions The research population criteria the investigators plan to select are as follows 1 Patients with confirmed Sepsis Patients participating in this study must meet the clinical diagnostic criteria for sepsis which means patients with evidence of infection and SOFA score 2 according to the definition of Sepsis-3 2 Age range The investigators plan to include adults and seniors with an age range of 18 years and older Exclusion criteria Exclude any patient with a cause that causes immune function abnormalities or affects the study results such as cancer congenital immune deficiency autoimmune disease etc In addition the investigators will exclude patients who have other apparently unrelated infections
For the selection of research groups the investigators will follow ethical principles and legal provisions to ensure that the research process and the rights and interests of participants are fully protected The investigators will conduct the research program after obtaining the approval of the Ethics Committee and protect their privacy and the confidentiality of personal information during the research process By selecting the appropriate study population the investigators hope to comprehensively and deeply explore the risk factors for adverse outcomes of sepsis provide scientific basis for accurate prediction and individualized management and ultimately improve the prognosis and survival rate of patients with sepsis
This study will use a multi-omics approach to comprehensively collect and measure data at multiple levels in order to comprehensively understand the risk factors for adverse outcomes in sepsis The following is what the investigators intend to collect and measure
1 Clinical data The investigators will collect the basic information of the patient including age gender BMI etc Clinical features associated with sepsis such as infection site pathogen type infection source complications etc will also be collected In addition clinical measures associated with adverse outcomes such as SOFA score APACHE II score blood pressure heart rate respiratory rate etc are also included to assess patient severity and organ function
2 Biological samples Blood samples of sepsis patients are extracted from the biobank established by the Department of Critical Care Medicine ethical approval number NoTJ-IRB20150318 for subsequent laboratory testing and measurement The blood samples will be used for gene sequencing measurement of inflammatory markers proteomic analysis and other key indicators including HIF1A HIF-1 alpha S100A12 S100 Calcium-Binding Protein A12 IL-33 Interleukin-33 HSPA5 Heat Shock Protein Family A Hsp70 Member 5 MMP8 Matrix Metalloproteinase 8 DSC2 Desmocollin-2 Bradykinin B1 Receptor BDKRB1 Bradykinin BK iNOS Inducible Nitric Oxide Synthase etc
3 Transcriptomics The data comes from the GEO database an open data set on the Internet Through RNA sequencing technology the investigators will analyze the gene expression profiles of patients at various time points to understand the changes in transcription levels at different stages and under different circumstances This will help identify biomarkers associated with adverse outcomes and potential therapeutic targets
In order to ensure the accuracy and consistency of data the investigators will follow a strict data collection and measurement operation process and use standardized measurement tools and laboratory techniques to operate In addition data quality is strictly controlled during data collection and data is encrypted and stored to protect patient privacy and personal information
Finally through statistical analysis the investigators hope to identify and quantify the risk factors for adverse outcomes and provide a scientific basis for prognostic assessment and treatment decisions of patients with sepsis
Study population
This study will select a certain scale of sepsis patients as the study population in order to study the risk factors of adverse outcomes of sepsis from multiple dimensions The research population criteria the investigators plan to select are as follows 1 Patients with confirmed Sepsis Patients participating in this study must meet the clinical diagnostic criteria for sepsis which means patients with evidence of infection and SOFA score 2 according to the definition of Sepsis-3 2 Age range The investigators plan to include adults and seniors with an age range of 18 years and older Exclusion criteria Exclude any patient with a cause that causes immune function abnormalities or affects the study results such as cancer congenital immune deficiency autoimmune disease etc In addition the investigators will exclude patients who have other apparently unrelated infections
For the selection of research groups the investigators will follow ethical principles and legal provisions to ensure that the research process and the rights and interests of participants are fully protected The investigators will conduct the research program after obtaining the approval of the Ethics Committee and protect their privacy and the confidentiality of personal information during the research process By selecting the appropriate study population the investigators hope to comprehensively and deeply explore the risk factors for adverse outcomes of sepsis provide scientific basis for accurate prediction and individualized management and ultimately improve the prognosis and survival rate of patients with sepsis
This study will use a multi-omics approach to comprehensively collect and measure data at multiple levels in order to comprehensively understand the risk factors for adverse outcomes in sepsis The following is what the investigators intend to collect and measure
1 Clinical data The investigators will collect the basic information of the patient including age gender BMI etc Clinical features associated with sepsis such as infection site pathogen type infection source complications etc will also be collected In addition clinical measures associated with adverse outcomes such as SOFA score APACHE II score blood pressure heart rate respiratory rate etc are also included to assess patient severity and organ function
2 Biological samples Blood samples of sepsis patients are extracted from the biobank established by the Department of Critical Care Medicine ethical approval number NoTJ-IRB20150318 for subsequent laboratory testing and measurement The blood samples will be used for gene sequencing measurement of inflammatory markers proteomic analysis and other key indicators including HIF1A HIF-1 alpha S100A12 S100 Calcium-Binding Protein A12 IL-33 Interleukin-33 HSPA5 Heat Shock Protein Family A Hsp70 Member 5 MMP8 Matrix Metalloproteinase 8 DSC2 Desmocollin-2 Bradykinin B1 Receptor BDKRB1 Bradykinin BK iNOS Inducible Nitric Oxide Synthase etc
3 Transcriptomics The data comes from the GEO database an open data set on the Internet Through RNA sequencing technology the investigators will analyze the gene expression profiles of patients at various time points to understand the changes in transcription levels at different stages and under different circumstances This will help identify biomarkers associated with adverse outcomes and potential therapeutic targets
In order to ensure the accuracy and consistency of data the investigators will follow a strict data collection and measurement operation process and use standardized measurement tools and laboratory techniques to operate In addition data quality is strictly controlled during data collection and data is encrypted and stored to protect patient privacy and personal information
Finally through statistical analysis the investigators hope to identify and quantify the risk factors for adverse outcomes and provide a scientific basis for prognostic assessment and treatment decisions of patients with sepsis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None