Systems Analysis of Antigen Presenting Cells in Human Sepsis (DENDRISEPSIS)
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|ClinicalTrials.gov Identifier: NCT03788772|
Recruitment Status : Recruiting
First Posted : December 28, 2018
Last Update Posted : December 3, 2019
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 monocytes/macrophages) 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:
- Systematic description and phenotypic analysis of circulating APC subsets in sepsis
- Association of APC subsets distribution, phenotype and function with severe sepsis physiopathology and relevant clinical outcomes (ICU-acquired infections and death)
- 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 study's 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.
|Condition or disease||Intervention/treatment||Phase|
|Sepsis Acute Circulatory Failure||Other: Multiple blood sampling Other: Simple blood sampling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Systems Analysis of Antigen Presenting Cells in Human Sepsis.|
|Actual Study Start Date :||July 15, 2019|
|Estimated Primary Completion Date :||July 15, 2022|
|Estimated Study Completion Date :||July 15, 2022|
Experimental: Adults patients hospitalized in ICU
Adult patients hospitalized in the intensive care unit (ICU) for severe infections (sepsis and septic shock) or or non-septic shock (cardiogenic or hemorrhagic shock)
Other: Multiple blood sampling
ICU septic and non-septic patients will be subjected to repeated blood samples at the following time-points: ICU admission, day 4/5, ICU and hospital discharge, 3 months. Patients exhibiting ICU-acquired infection will also be sampled at the time of diagnosis (up to 6 additional blood samples of 20 mL within 3 months = 120mL)
Other: Simple blood sampling
Healthy controls (blood donors and patients undergoing elective cataract surgery) will be subjected to one single blood sample of 20 mL.
- ICU-acquired infections (nosocomial infections) [ Time Frame: up to 3 months after the inclusion ]Infections not present at the time of ICU admission and diagnosed at least after 48 hours in the ICU
- In-hospital death [ Time Frame: up to 3 months after the inclusion ]date of death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788772
|Contact: Frédéric PENE, MD PhD||+33 1 58 41 46 email@example.com|
|Cochin Hospital, AP-HP||Recruiting|
|Paris, France, 75014|
|Contact: Frédéric PENE, MD PhD +33 1 58 41 46 77 firstname.lastname@example.org|
|Principal Investigator:||Frédéric PENE, MD PhD||Assistance Publique - Hôpitaux de Paris|
|Study Director:||Vassili SOUMELIS, MD PhD||Assistance Publique - Hôpitaux de Paris|