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Not yet recruiting NCT04841824

TRanscriptomic Analysis of Circulating Endothelial Cells During Sepsis - TRACES Study

— Observational Critical Illness With or Without Sepsis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Observational study.
Who it may be relevant to
Registry conditions: Critical Illness With or Without Sepsis. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

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

Primary outcome measures

  • Gene expression based on transcriptom analysis of circulating endothelial cells [Time frame: Day 1]
Secondary outcome measures (12)
  • Counts of circulating endothelial cells [Time frame: Day 1 and Day 3]
  • Sequential Organ Failure Assessment (SOFA) score [Time frame: Day 1, Day 3, Day 7]
  • Sequential Organ Failure Assessment (SOFA) hemodynamic sub-score [Time frame: Day 1, Day 3, Day 7]
  • Sequential Organ Failure Assessment (SOFA) respiratory sub-score [Time frame: Day 1, Day 3, Day 7]
  • Sequential Organ Failure Assessment (SOFA) neurological sub-score [Time frame: Day 1, Day 3, Day 7]
  • Sequential Organ Failure Assessment (SOFA) hematological sub-score [Time frame: Day 1, Day 3, Day 7]
  • Intensive care unit (ICU) mortality [Time frame: ICU length of stay]
  • D28 mortality [Time frame: Day 28]
  • Hospital mortality [Time frame: Day 90]
  • Duration of ventilation [Time frame: Day 28]
  • Duration of renal replacement therapy (RRT) [Time frame: Day 28]
  • Duration of vasopressors therapy [Time frame: Day 28]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

France · 1 center
  • AP-HP Hôpital Saint Louis — Paris

Identifiers

NCT: NCT04841824 · APHP201060

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗