Critical Illness With or Without SepsisTRACESNCT04841824
TRanscriptomic Analysis of Circulating Endothelial Cells During Sepsis - TRACES Study
An observational study of Critical Illness With or Without Sepsis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Critical Illness With or Without Sepsis
- What is being tested?
- Observational study
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2021to Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill adult patients hospitalized in an intensive care unit, with or without sepsis.
Who may be able to join
- 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)
Who cannot join
- Patient under legal protection
- Patient under national medical help system
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Critical Illness With or Without Sepsis
- Being tested
- Observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
Observational study. Groups are defined based on baseline patients' characteristics : presence or absence of sepsis.
| Study group | Role | What they receive |
|---|---|---|
| Critically ill patients with sepsis | Not described Receives: Other: Observational study | |
| Critically ill patients without sepsis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene expression based on transcriptom analysis of circulating endothelial cells
Gene expression based on transcriptom analysis of circulating endothelial cells (RNAseq)
Measured: Day 1
Secondary outcomes (20)
Counts of circulating endothelial cells
Counts of circulating endothelial cells, including progenitor cells
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Day 1, Day 3, Day 7
Intensive care unit (ICU) mortality
Death during ICU stay
Measured: ICU length of stay
D28 mortality
Death within 28 days of intensive care unit
Measured: Day 28
Hospital mortality
Death within 90 days of intensive care unit
Measured: Day 90
Duration of ventilation
Number of days alive without ventilation up to Day 28
Measured: Day 28
Duration of renal replacement therapy (RRT)
Number of days alive without RRT up to Day 28
Measured: Day 28
Duration of vasopressors therapy
Number of days alive without vasopressors up to Day 28
Measured: Day 28
Dose of vasopressors
Dose of vasopressors, in patients who received vasopressors
Measured: 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
Measured: Day 28
Circulating endothelial cells cytokines profile
Dosage of cytokines from circulating endothelial cells
Measured: Day 1 and 3
Circulating endothelial cells chemokines profile
Dosage of chemokines from circulating endothelial cells
Measured: Day 1 and 3
Expression of membrane proteins of endothelial cells
Expression of membrane proteins of endothelial cells by flow cytometry
Measured: Day 1 and 3
Infection site
Infection site for patients with sepsis
Measured: Day 1
Infection identification
Identified germs for patients with sepsis
Measured: Day 1
Number of participants with different types of antibiotic treatment
Antibiotic treatments for patients with sepsis during intensive care unit (ICU) stay
Measured: Length of ICU stay, assessed up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study startApr 2021 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Illness With or Without SepsisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841824
- Sponsor's protocol ID
- APHP201060
- Acronym
- TRACES
- Status last verified
- Apr 2021
- First submitted
- 2 Apr 2021
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysfunction and Endothelial Repair in Sepsis Shock : RNAseq Transcriptomic Analysis of Circulating Endothelial Cells
- ClinicalTrials.gov ID
- NCT04841824
- Acronym / sponsor ID
- TRACES / APHP201060
- Conditions
- Critical Illness With or Without Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 12 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients with sepsis | – | Other: Observational study |
| Critically ill patients without sepsis | – | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill adult patients hospitalized in an intensive care unit, with or without sepsis.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- Patient under legal protection
- Patient under national medical help system
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational studyObservational study. Groups are defined based on baseline patients' characteristics : presence or absence of sepsis. | Other | Critically ill patients with sepsis |
Primary outcome
Gene expression based on transcriptom analysis of circulating endothelial cells
Time frame: Day 1
Gene expression based on transcriptom analysis of circulating endothelial cells (RNAseq)
20 secondary outcomes
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
Dose of vasopressors
Time frame: ICU length of stay, assessed up to 90 days
Duration of intensive care unit (ICU) stay
Time frame: Day 28
Circulating endothelial cells cytokines profile
Time frame: Day 1 and 3
Circulating endothelial cells chemokines profile
Time frame: Day 1 and 3
Expression of membrane proteins of endothelial cells
Time frame: Day 1 and 3
Infection site
Time frame: Day 1
Infection identification
Time frame: Day 1
Number of participants with different types of antibiotic treatment
Time frame: Length of ICU stay, assessed up to 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Critical Illness With or Without Sepsis
RecruitingObservational study
Metabolic and Functional Study of γδ T Cells in Critically Ill Patients
Sepsis, Critical Illness
Recruiting
Characterization and Longitudinal Monitoring of Muscular Phenotype in Patients Admitted to Intensive Care for Sepsis
Sepsis, Myopathy Critical Illness
RecruitingObservational study
Peripheral Perfusion Index Trajectory to Predict 28-Day Mortality in Patients With Sepsis in the Intensive Care Unit
Sepsis, Critical Illness
RecruitingObservational study
IMMUNOREA - Immunological and Inflammatory Determinants Associated With the Prognosis of Intensive Care Patients
Critical Illness, Intensive Care Patients
Not yet recruitingPhase 2
NAI Plus Standard of Care Compared With Placebo Plus Standard of Care in Critically Ill Adults With Sepsis
Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness With or Without Sepsis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lara Zafrani, MD PhD (+33 1 42 49 94 19, lara.zafrani@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene expression based on transcriptom analysis of circulating endothelial cells (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2021; AzTrials last refreshed its copy on 2 Nov 2026.