Clinical trial NCT04841824: TRanscriptomic Analysis of Circulating Endothelial Cells During Sepsis - TRACES Study
Official title: Dysfunction and Endothelial Repair in Sepsis Shock : RNAseq Transcriptomic Analysis of Circulating Endothelial Cells
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Critical Illness With or Without Sepsis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill adult patients hospitalized in an intensive care unit, with or without sepsis.

Brief summary: Vascular dysfunction is an important mechanism involved in organ failure, in the setting of sepsis condition, with different types of circulating endothelial cells.Transcriptom analysis via RNAseq in different types of circulating endothelial cells, comapring critically ill patients with or without sepsis will allow determining differential gene expression for signal pathways in endothelial alteration and restoration associated with sepsis.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 85 years
* Admission in intensive care with or without sepsis
* Health insurance as per the national insurance system
* Informed and unopposed patient for participation (or referend closed one)

Exclusion Criteria:

* Patient under legal protection
* Patient under national medical help system
* Pregnancy

Primary outcomes:
measure: Gene expression based on transcriptom analysis of circulating endothelial cells
timeFrame: Day 1
Secondary outcomes:
measure: Counts of circulating endothelial cells
timeFrame: Day 1 and Day 3
measure: Sequential Organ Failure Assessment (SOFA) score
timeFrame: Day 1, Day 3, Day 7
measure: Sequential Organ Failure Assessment (SOFA) hemodynamic sub-score
timeFrame: Day 1, Day 3, Day 7
measure: Sequential Organ Failure Assessment (SOFA) respiratory sub-score
timeFrame: Day 1, Day 3, Day 7
measure: Sequential Organ Failure Assessment (SOFA) neurological sub-score
timeFrame: Day 1, Day 3, Day 7
measure: Sequential Organ Failure Assessment (SOFA) hematological sub-score
timeFrame: Day 1, Day 3, Day 7
measure: Intensive care unit (ICU) mortality
timeFrame: ICU length of stay
measure: D28 mortality
timeFrame: Day 28
measure: Hospital mortality
timeFrame: Day 90
measure: Duration of ventilation
timeFrame: Day 28
measure: Duration of renal replacement therapy (RRT)
timeFrame: Day 28
measure: Duration of vasopressors therapy
timeFrame: Day 28
measure: Dose of vasopressors
timeFrame: ICU length of stay, assessed up to 90 days
measure: Duration of intensive care unit (ICU) stay
timeFrame: Day 28
measure: Circulating endothelial cells cytokines profile
timeFrame: Day 1 and 3
measure: Circulating endothelial cells chemokines profile
timeFrame: Day 1 and 3
measure: Expression of membrane proteins of endothelial cells
timeFrame: Day 1 and 3
measure: Infection site
timeFrame: Day 1
measure: Infection identification
timeFrame: Day 1
measure: Number of participants with different types of antibiotic treatment
timeFrame: Length of ICU stay, assessed up to 90 days
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP Hôpital Saint Louis
Study officials:
References: