Ignite Creation Date:
2024-05-06 @ 12:31 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03788772
Status:
UNKNOWN
Last Update Posted:
2019-12-03
First Post:
2018-12-20
Brief Title:
Systems Analysis of Antigen Presenting Cells in Human Sepsis
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Systems Analysis of Antigen Presenting Cells in Human Sepsis
Status:
UNKNOWN
Status Verified Date:
2019-07
Last Known Status:
RECRUITING
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:
DENDRISEPSIS
Brief Summary:
Sepsis is a common life-threatening inflammatory response to infection and is the leading cause of death in the intensive care unit Septic patients exhibit a complex immunosuppressive response affecting both innate and adaptive components of immunity with a possible link to nosocomial infections However the molecular and cellular mechanisms resulting in secondary immunosuppression remain poorly understood but may involve the antigen-presenting cells APC including dendritic cells and monocytesmacrophages that link innate and adaptive immunity Furthermore the increasing phenotypic and functional heterogeneity of APC subsets raise the question of their respective role in sepsis We propose to address the pathophysiologal role of APC using systems biology approaches in human sepsis
The objective is to go from low- to high-resolution analysis of APC subset diversity and underlying molecular and functional features in sepsis The global objective will be reached through
1 Systematic description and phenotypic analysis of circulating APC subsets in sepsis
2 Association of APC subsets distribution phenotype and function with severe sepsis physiopathology and relevant clinical outcomes ICU-acquired infections and death
3 High-resolution molecular profiling of circulating APC subsets using population level and single cell RNAseq
To this aim the investigator designed a prospective interventional study in order to collect blood samples at significant time points in patients with sepsis or septic shock the population of interest and relevant control subjects either critically ill patients with non-septic acute circulatory failure or age-matched healthy subjects The studys intervention is limited to additional blood samples The risks and constraints are related to additional blood samples maximum 120mL which will be performed either from an arterial catheter when present in ICU patients or from a venous puncture for patients without arterial catheters and for healthy volunteers
The objective is to go from low- to high-resolution analysis of APC subset diversity and underlying molecular and functional features in sepsis The global objective will be reached through
1 Systematic description and phenotypic analysis of circulating APC subsets in sepsis
2 Association of APC subsets distribution phenotype and function with severe sepsis physiopathology and relevant clinical outcomes ICU-acquired infections and death
3 High-resolution molecular profiling of circulating APC subsets using population level and single cell RNAseq
To this aim the investigator designed a prospective interventional study in order to collect blood samples at significant time points in patients with sepsis or septic shock the population of interest and relevant control subjects either critically ill patients with non-septic acute circulatory failure or age-matched healthy subjects The studys intervention is limited to additional blood samples The risks and constraints are related to additional blood samples maximum 120mL which will be performed either from an arterial catheter when present in ICU patients or from a venous puncture for patients without arterial catheters and for healthy volunteers
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-A01934-51 | OTHER | ID-RCB | None |