A Systems Immunology Approach to Characterize the Immune Response in Sepsis and Its Long-term Complications

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

Sepsis occurs when an infection, caused by bacteria, a virus, or a fungus, enters the body and throws the immune system out of balance. Instead of protecting the body, the immune response may become too strong and start damaging healthy organs, or it may become too weak and fail to control the infection. Both situations can be life-threatening. Even people who survive sepsis may experience long-term health problems, such as new infections, heart and blood vessel diseases, or early death. This study aims to better understand how the immune system behaves during and after sepsis. We believe that there are different types of immune responses in sepsis, called immunotypes. We will identify these immunotypes by examining substances in the blood and changes in immune cells. We will then study which immunotypes help protect patients and which may cause short- or long-term harm. Understanding these immunotypes may make it possible in the future to quickly determine what type of immune response a patient with sepsis has. This could help doctors choose the best treatment for each individual patient. A total of 400 patients with sepsis from the intensive care unit will take part in this study. We will collect blood samples at several time points and gather information about their health. Participants will be followed from their intensive care admission until one year after they return home.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults (≥18years).

• Sepsis 3 criteria: defined as having a suspected or documented infection accompanied by organ dysfunction, represented by a total Sequential Organ Failure Assessment (SOFA-2) score 2 or more for new admissions or as 2 or more point-increase of the total SOFA-2 score for hospitalized patients.

Locations
Other Locations
Netherlands
Radboud University Medical Center
RECRUITING
Nijmegen
Contact Information
Primary
Tristan Couwenbergh
tristan.couwenbergh@radboudumc.nl
+31613456047
Backup
Wouter A. van der Heijden, dr.
Wouter.vanderHeijden@radboudumc.nl
Time Frame
Start Date: 2025-11-03
Estimated Completion Date: 2028-12-01
Participants
Target number of participants: 400
Related Therapeutic Areas
Sponsors
Leads: Radboud University Medical Center
Collaborators: Dutch Research Council

This content was sourced from clinicaltrials.gov