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REAnimation Low Immune Status Markers

NCT02638779 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 552

Last updated 2025-12-19

No results posted yet for this study

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

BIOLOGICAL

Blood sampling

Specific Blood sampling will be performed in patients and healthy volunteers

Sponsors & Collaborators

  • Bioaster

    collaborator OTHER

  • BioMérieux

    collaborator INDUSTRY

  • Sanofi

    collaborator INDUSTRY

  • Hospices Civils de Lyon

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-11
Primary Completion
2018-06-27
Completion
2018-06-27

Countries

  • France

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02638779 on ClinicalTrials.gov