TRanscriptomic Analysis of Circulating Endothelial Cells During Sepsis - TRACES Study

NCT04841824 | Not Yet Recruiting

• 1 other identifier: APHP201060
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness With or Without Sepsis

Outcome Measures

Primary Outcomes (1)

• Gene expression based on transcriptom analysis of circulating endothelial cells

  Gene expression based on transcriptom analysis of circulating endothelial cells (RNAseq)

  Day 1

Secondary Outcomes (20)

• Counts of circulating endothelial cells

  Day 1 and Day 3

• Sequential Organ Failure Assessment (SOFA) score

  Day 1, Day 3, Day 7

• Sequential Organ Failure Assessment (SOFA) hemodynamic sub-score

  Day 1, Day 3, Day 7

• Sequential Organ Failure Assessment (SOFA) respiratory sub-score

  Day 1, Day 3, Day 7

• Sequential Organ Failure Assessment (SOFA) neurological sub-score

  Day 1, Day 3, Day 7

Study Arms (2)

Critically ill patients with sepsis

Other: Observational study

Critically ill patients without sepsis

Interventions

Observational study OTHER

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

Critically ill patients with sepsis

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

AP-HP Hôpital Saint Louis

Paris, 75010, France

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Lara Zafrani, MD PhD

CONTACT

+33 1 42 49 94 19; lara.zafrani@aphp.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 12, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 12, 2021

Record last verified: 2021-04

Locations

FR (1)