TRanscriptomic Analysis of Circulating Endothelial Cells During Sepsis - TRACES Study (TRACES)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Critical Illness With or Without Sepsis
• Intervention / Treatment: Other: Observational study

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Lara Zafrani, MD PhD; Phone Number: +33 1 42 49 94 19; Email: lara.zafrani@aphp.fr

Study Locations

• France
  • Paris, France, 75010
    • AP-HP Hôpital Saint Louis
    • Contact: Lara Zafrani, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Critically ill adult patients hospitalized in an intensive care unit, with or without sepsis.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Critically ill patients with sepsis	Other: Observational study; Observational study. Groups are defined based on baseline patients' characteristics : presence or absence of sepsis.
Critically ill patients without sepsis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gene expression based on transcriptom analysis of circulating endothelial cells	Gene expression based on transcriptom analysis of circulating endothelial cells (RNAseq)	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Counts of circulating endothelial cells	Counts of circulating endothelial cells, including progenitor cells	Day 1 and Day 3
Sequential Organ Failure Assessment (SOFA) score	Sequential Organ Failure Assessment (SOFA) score, ranging from 0 (best: absence of organ failure) to 24 (worse: multiple organ failure)	Day 1, Day 3, Day 7
Sequential Organ Failure Assessment (SOFA) hemodynamic sub-score	Sequential Organ Failure Assessment (SOFA) hemodynamic sub-score, ranging from 0 (best: absence of hemodynamic failure) to 4 (worse: hemodynamic failure)	Day 1, Day 3, Day 7
Sequential Organ Failure Assessment (SOFA) respiratory sub-score	Sequential Organ Failure Assessment (SOFA) respiratory sub-score, ranging from 0 (best: absence of respiratory failure) to 4 (worse: respiratory failure)	Day 1, Day 3, Day 7
Sequential Organ Failure Assessment (SOFA) neurological sub-score	Sequential Organ Failure Assessment (SOFA) neurological sub-score, ranging from 0 (best: absence of neurological failure) to 4 (worse: neurological failure)	Day 1, Day 3, Day 7
Sequential Organ Failure Assessment (SOFA) hematological sub-score	Sequential Organ Failure Assessment (SOFA) hematological sub-score, ranging from 0 (best: absence of hematological failure) to 4 (worse: hematological failure)	Day 1, Day 3, Day 7
Intensive care unit (ICU) mortality	Death during ICU stay	ICU length of stay
D28 mortality	Death within 28 days of intensive care unit	Day 28
Hospital mortality	Death within 90 days of intensive care unit	Day 90
Duration of ventilation	Number of days alive without ventilation up to Day 28	Day 28
Duration of renal replacement therapy (RRT)	Number of days alive without RRT up to Day 28	Day 28
Duration of vasopressors therapy	Number of days alive without vasopressors up to Day 28	Day 28
Dose of vasopressors	Dose of vasopressors, in patients who received vasopressors	ICU length of stay, assessed up to 90 days
Duration of intensive care unit (ICU) stay	Number of days alive outside the ICU up to D28	Day 28
Circulating endothelial cells cytokines profile	Dosage of cytokines from circulating endothelial cells	Day 1 and 3
Circulating endothelial cells chemokines profile	Dosage of chemokines from circulating endothelial cells	Day 1 and 3
Expression of membrane proteins of endothelial cells	Expression of membrane proteins of endothelial cells by flow cytometry	Day 1 and 3
Infection site	Infection site for patients with sepsis	Day 1
Infection identification	Identified germs for patients with sepsis	Day 1
Number of participants with different types of antibiotic treatment	Antibiotic treatments for patients with sepsis during intensive care unit (ICU) stay	Length of ICU stay, assessed up to 90 days

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): April 1, 2026
• Study Completion (Anticipated): August 1, 2026

Study Registration Dates

• First Submitted: April 2, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 12, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2021
• Last Update Submitted That Met QC Criteria: April 8, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Sepsis; Toxemia; Critical Illness
• Other Study ID Numbers: APHP201060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No