TRanscriptomic Analysis of Circulating Endothelial Cells During Sepsis - TRACES Study

Not yet recruiting

• Conditions: Critical Illness With or Without Sepsis
• Interventions: Other: Observational study

• Registration Number: NCT04841824
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-04
• Study Start: 2021-04
• Study First Submitted: 2021-04-02
• Study First Submitted QC: 2021-04-08
• Last Update Submitted: 2021-04-08
• Study First Posted: 2021-04-12
• Last Update Posted: 2021-04-12
• Primary Completion: 2026-04
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Critically ill patients with sepsis	Observational study	-

Primary Outcome Measures

Name	Time	Method
Gene expression based on transcriptom analysis of circulating endothelial cells	Day 1	Gene expression based on transcriptom analysis of circulating endothelial cells (RNAseq)

Secondary Outcome Measures

Name	Time	Method
Hospital mortality	Day 90	Death within 90 days of intensive care unit
Duration of renal replacement therapy (RRT)	Day 28	Number of days alive without RRT up to Day 28
Counts of circulating endothelial cells	Day 1 and Day 3	Counts of circulating endothelial cells, including progenitor cells
Sequential Organ Failure Assessment (SOFA) respiratory sub-score	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	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) hemodynamic sub-score	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)
Circulating endothelial cells cytokines profile	Day 1 and 3	Dosage of cytokines from circulating endothelial cells
Sequential Organ Failure Assessment (SOFA) hematological sub-score	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)
Duration of vasopressors therapy	Day 28	Number of days alive without vasopressors up to Day 28
Dose of vasopressors	ICU length of stay, assessed up to 90 days	Dose of vasopressors, in patients who received vasopressors
Duration of intensive care unit (ICU) stay	Day 28	Number of days alive outside the ICU up to D28
Infection identification	Day 1	Identified germs for patients with sepsis
Circulating endothelial cells chemokines profile	Day 1 and 3	Dosage of chemokines from circulating endothelial cells
Sequential Organ Failure Assessment (SOFA) score	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)
Intensive care unit (ICU) mortality	ICU length of stay	Death during ICU stay
D28 mortality	Day 28	Death within 28 days of intensive care unit
Infection site	Day 1	Infection site for patients with sepsis
Duration of ventilation	Day 28	Number of days alive without ventilation up to Day 28
Expression of membrane proteins of endothelial cells	Day 1 and 3	Expression of membrane proteins of endothelial cells by flow cytometry
Number of participants with different types of antibiotic treatment	Length of ICU stay, assessed up to 90 days	Antibiotic treatments for patients with sepsis during intensive care unit (ICU) stay

Trial Locations

Locations (1)

AP-HP Hôpital Saint Louis; 🇫🇷 Paris, France