Critical Illness With or Without Sepsis Clinical Trial
— TRACESOfficial title:
Dysfunction and Endothelial Repair in Sepsis Shock : RNAseq Transcriptomic Analysis of Circulating Endothelial Cells
| NCT number | NCT04841824 |
| Other study ID # | APHP201060 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 2021 |
| Est. completion date | August 2026 |
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.
| Status | Not yet recruiting |
| Enrollment | 1000 |
| Est. completion date | August 2026 |
| Est. primary completion date | April 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | AP-HP Hôpital Saint Louis | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Gene expression based on transcriptom analysis of circulating endothelial cells | Gene expression based on transcriptom analysis of circulating endothelial cells (RNAseq) | Day 1 | |
| Secondary | Counts of circulating endothelial cells | Counts of circulating endothelial cells, including progenitor cells | Day 1 and Day 3 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Intensive care unit (ICU) mortality | Death during ICU stay | ICU length of stay | |
| Secondary | D28 mortality | Death within 28 days of intensive care unit | Day 28 | |
| Secondary | Hospital mortality | Death within 90 days of intensive care unit | Day 90 | |
| Secondary | Duration of ventilation | Number of days alive without ventilation up to Day 28 | Day 28 | |
| Secondary | Duration of renal replacement therapy (RRT) | Number of days alive without RRT up to Day 28 | Day 28 | |
| Secondary | Duration of vasopressors therapy | Number of days alive without vasopressors up to Day 28 | Day 28 | |
| Secondary | Dose of vasopressors | Dose of vasopressors, in patients who received vasopressors | ICU length of stay, assessed up to 90 days | |
| Secondary | Duration of intensive care unit (ICU) stay | Number of days alive outside the ICU up to D28 | Day 28 | |
| Secondary | Circulating endothelial cells cytokines profile | Dosage of cytokines from circulating endothelial cells | Day 1 and 3 | |
| Secondary | Circulating endothelial cells chemokines profile | Dosage of chemokines from circulating endothelial cells | Day 1 and 3 | |
| Secondary | Expression of membrane proteins of endothelial cells | Expression of membrane proteins of endothelial cells by flow cytometry | Day 1 and 3 | |
| Secondary | Infection site | Infection site for patients with sepsis | Day 1 | |
| Secondary | Infection identification | Identified germs for patients with sepsis | Day 1 | |
| Secondary | 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 |