NCT02638779

REAnimation Low Immune Status Markers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 552 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Septic Shock
• Severe Trauma
• Severe Burn
• Major Surgery

Interventions

Type	Name	Description
BIOLOGICAL	Blood sampling	Specific Blood sampling will be performed in patients and healthy volunteers

Timeline

• Start date: 2015-12-11
• Primary completion: 2018-06-27
• Completion: 2018-06-27
• First posted: 2015-12-23
• Last updated: 2025-12-19

Locations

1 site across 1 country: France