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Clinical Trial Details — Status: Not yet recruiting

Administrative data

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

Study information

Verified date April 2021
Source Assistance Publique - Hôpitaux de Paris
Contact Lara Zafrani, MD PhD
Phone +33 1 42 49 94 19
Email lara.zafrani@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France AP-HP Hôpital Saint Louis Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

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