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TRanscriptomic Analysis of Circulating Endothelial Cells During Sepsis - TRACES Study

Dysfunction and Endothelial Repair in Sepsis Shock : RNAseq Transcriptomic Analysis of Circulating Endothelial Cells

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04841824
Acronym
TRACES
Enrollment
1000
Registered
2021-04-12
Start date
2021-04-30
Completion date
2026-08-31
Last updated
2021-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness 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.

Interventions

OTHERObservational study

Observational study. Groups are defined based on baseline patients' characteristics : presence or absence of sepsis.

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Gene expression based on transcriptom analysis of circulating endothelial cellsDay 1Gene expression based on transcriptom analysis of circulating endothelial cells (RNAseq)

Secondary

MeasureTime frameDescription
Sequential Organ Failure Assessment (SOFA) scoreDay 1, Day 3, Day 7Sequential Organ Failure Assessment (SOFA) score, ranging from 0 (best: absence of organ failure) to 24 (worse: multiple organ failure)
Sequential Organ Failure Assessment (SOFA) hemodynamic sub-scoreDay 1, Day 3, Day 7Sequential Organ Failure Assessment (SOFA) hemodynamic sub-score, ranging from 0 (best: absence of hemodynamic failure) to 4 (worse: hemodynamic failure)
Sequential Organ Failure Assessment (SOFA) respiratory sub-scoreDay 1, Day 3, Day 7Sequential Organ Failure Assessment (SOFA) respiratory sub-score, ranging from 0 (best: absence of respiratory failure) to 4 (worse: respiratory failure)
Sequential Organ Failure Assessment (SOFA) neurological sub-scoreDay 1, Day 3, Day 7Sequential Organ Failure Assessment (SOFA) neurological sub-score, ranging from 0 (best: absence of neurological failure) to 4 (worse: neurological failure)
Sequential Organ Failure Assessment (SOFA) hematological sub-scoreDay 1, Day 3, Day 7Sequential Organ Failure Assessment (SOFA) hematological sub-score, ranging from 0 (best: absence of hematological failure) to 4 (worse: hematological failure)
Intensive care unit (ICU) mortalityICU length of stayDeath during ICU stay
D28 mortalityDay 28Death within 28 days of intensive care unit
Hospital mortalityDay 90Death within 90 days of intensive care unit
Duration of ventilationDay 28Number of days alive without ventilation up to Day 28
Counts of circulating endothelial cellsDay 1 and Day 3Counts of circulating endothelial cells, including progenitor cells
Duration of vasopressors therapyDay 28Number of days alive without vasopressors up to Day 28
Dose of vasopressorsICU length of stay, assessed up to 90 daysDose of vasopressors, in patients who received vasopressors
Duration of intensive care unit (ICU) stayDay 28Number of days alive outside the ICU up to D28
Circulating endothelial cells cytokines profileDay 1 and 3Dosage of cytokines from circulating endothelial cells
Circulating endothelial cells chemokines profileDay 1 and 3Dosage of chemokines from circulating endothelial cells
Expression of membrane proteins of endothelial cellsDay 1 and 3Expression of membrane proteins of endothelial cells by flow cytometry
Infection siteDay 1Infection site for patients with sepsis
Infection identificationDay 1Identified germs for patients with sepsis
Number of participants with different types of antibiotic treatmentLength of ICU stay, assessed up to 90 daysAntibiotic treatments for patients with sepsis during intensive care unit (ICU) stay
Duration of renal replacement therapy (RRT)Day 28Number of days alive without RRT up to Day 28

Countries

France

Contacts

Primary ContactLara Zafrani, MD PhD
lara.zafrani@aphp.fr+33 1 42 49 94 19

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026