AP-HP Hôpital Saint Louis
Paris, 75010, France
Location contact
Lara Zafrani, MD PhD
CONTACT
Not Yet Recruiting
NCT Number: NCT04841824
TRanscriptomic Analysis of Circulating Endothelial Cells During Sepsis - TRACES Study
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year–85 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
observational study
OtherObservational study. Groups are defined based on baseline patients' characteristics : presence or absence of sepsis.
Primary outcomes
-
Gene expression based on transcriptom analysis of circulating endothelial cells
Time frame: Day 1
Gene expression based on transcriptom analysis of circulating endothelial cells (RNAseq)
Secondary outcomes
-
Counts of circulating endothelial cells
Time frame: Day 1 and Day 3
Counts of circulating endothelial cells, including progenitor cells
-
Sequential Organ Failure Assessment (SOFA) score
Time frame: Day 1, Day 3, Day 7
Sequential 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-score
Time frame: Day 1, Day 3, Day 7
Sequential 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-score
Time frame: Day 1, Day 3, Day 7
Sequential 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-score
Time frame: Day 1, Day 3, Day 7
Sequential 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-score
Time frame: Day 1, Day 3, Day 7
Sequential Organ Failure Assessment (SOFA) hematological sub-score, ranging from 0 (best: absence of hematological failure) to 4 (worse: hematological failure)
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Intensive care unit (ICU) mortality
Time frame: ICU length of stay
Death during ICU stay
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D28 mortality
Time frame: Day 28
Death within 28 days of intensive care unit
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Hospital mortality
Time frame: Day 90
Death within 90 days of intensive care unit
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Duration of ventilation
Time frame: Day 28
Number of days alive without ventilation up to Day 28
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Duration of renal replacement therapy (RRT)
Time frame: Day 28
Number of days alive without RRT up to Day 28
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Duration of vasopressors therapy
Time frame: Day 28
Number of days alive without vasopressors up to Day 28
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Dose of vasopressors
Time frame: ICU length of stay, assessed up to 90 days
Dose of vasopressors, in patients who received vasopressors
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Duration of intensive care unit (ICU) stay
Time frame: Day 28
Number of days alive outside the ICU up to D28
-
Circulating endothelial cells cytokines profile
Time frame: Day 1 and 3
Dosage of cytokines from circulating endothelial cells
-
Circulating endothelial cells chemokines profile
Time frame: Day 1 and 3
Dosage of chemokines from circulating endothelial cells
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Expression of membrane proteins of endothelial cells
Time frame: Day 1 and 3
Expression of membrane proteins of endothelial cells by flow cytometry
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Infection site
Time frame: Day 1
Infection site for patients with sepsis
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Infection identification
Time frame: Day 1
Identified germs for patients with sepsis
-
Number of participants with different types of antibiotic treatment
Time frame: Length of ICU stay, assessed up to 90 days
Antibiotic treatments for patients with sepsis during intensive care unit (ICU) stay
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Other
Registry information
Official study title
Dysfunction and Endothelial Repair in Sepsis Shock : RNAseq Transcriptomic Analysis of Circulating Endothelial Cells
Acronym: TRACES
Important dates
- Study start
- 2021
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Apr 12, 2021
- Registry last updated
- Apr 12, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.