REAnimation Low Immune Status Markers (NCT02638779) | Clinical Trial Compass
CompletedNot Applicable
REAnimation Low Immune Status Markers
France552 participantsStarted 2015-12-11
Plain-language summary
The fact that sepsis disrupts immune system homeostasis by inducing an initial cytokine storm, that participates to occurrence of organ failures and early death, followed by a compensatory anti-inflammatory response leading to immunosuppression, is now well established. This immunomodulating response results in a higher risk of secondary infections and is associated to 2/3 of deaths related to septic shocks. Follow up of patients' immune status with time is crucial to guide therapy management. Objective of REALISM project is to demonstrate existence of this immunosuppression phase, by providing strong epidemiologic data for septic shock patients, but also by extension to other situations of inflammatory aggressions like severe severe trauma or burns, or major surgery. This project will provide tools to predict occurrence of secondary infections and guide patient management by comparing innovating immunomonitoring tools to reference tests non already adapted to a routine patient management.
Targeted populations are adult patients hospitalized for septic shock, severe trauma (including severe burn) or major surgery and healthy volunteers, whom blood samples will serve to validate reference intervals of the two reference tests.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria for patients
* Patient or next of kin having been informed of the conditions of the study and having signed the informed consent form
* Patient hospitalized for :
* Septic shock
* Severe trauma (including severe burn)
* Major surgery
Inclusion criteria for healthy volunteers
* Normal clinical examination
* Signed informed consent form
* Person with social security insurance
Exclusion criteria for patients
* Patient with severe neutropenia (neutrophil count \<0.5 g/l)
* Patients receiving immunosuppressive therapy
* Patients receiving corticosteroids (IV or Per os)
* Use of therapeutic antibodies
* Hematological disease under treatment, or treated within 5 years before inclusion
* End of chemotherapy within the 6 months prior to inclusion
* Patient with innate or acquired immune deficiency (for example severe combined immunodeficiency, HIV or AIDS, any stage)
* Patients for whom a care limitation was pronounced at time of enrolment
* Anticipated length of stay before discharge from the ICU is estimated at less than 48 hours
* Participation in an intervention study
* Extra-corporeal circulation in the month preceding inclusion in case of cardiac surgery
* Pregnant or breastfeeding women
* Patient with no social security insurance, with restricted liberty or under legal protection
Exclusion criteria for healthy volunteers
* Person with an infectious syndrome during the last 90 days
* Extreme physical stress within the last week
* Person having re…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of patients meeting the definition of of injury-induced-immunosuppression