A Study on How the Immune System Responds to Sepsis and Its Long-term Effects

NCT07273344 | Recruiting

• 1 other identifier: NL010169
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis

Keywords

observational; sepsis; cohort study; immune endotypes; endotypes; immunotypes; post-sepsis syndrome

Outcome Measures

Primary Outcomes (3)

• Classification of hospitalized sepsis patients into distinct immunotypes.

  Day 0 (within 48 hours of intensive care unit admission or start of sepsis)

• Classification of hospitalized sepsis patients into distinct immunotypes.

  Day 3 (defined as 3 days after day 0)

• Classification of hospitalized sepsis patients into distinct immunotypes.

  At hospital discharge.

Secondary Outcomes (2)

• Detection of persistent immunotypes at following hospital discharge.

  Three months after hospital discharge.

• Detection of persistent immunotypes at following hospital discharge.

  Twelve months after hospital discharge.

Interventions

blood sampling OTHER

This study involves no interventions beyond scheduled blood collection.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ICU or medium care patients diagnosed with sepsis, as defined by the Sepsis-3 criteria, from the Radboudumc, Canisius Wilhelmina Ziekenhuis, Rijnstate Ziekenhuis, and Jeroen Bosch Ziekenhuis.

You may qualify if:

• 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.

You may not qualify if:

• Known chemotherapy-induced or long-term neutropenia.
• Known CD4 counts \<400 cells/µL.
• History of primary immunodeficiency
• Chronic intake of corticosteroids (defined as total daily dose equal or greater than 0.4 mg/kg of equivalent prednisone for more than the last 15 days).
• Current use of biologics.
• Solid organ transplant recipients.
• Recipients of allogeneic bone marrow transplants.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Dutch Research Council: collaborator

Study Sites (1)

Radboud University Medical Center

Nijmegen, Gelderland, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, plasma, peripheral blood mononuclear cells (PBMC's), PAXgene tubes.

MeSH Terms

Conditions

Sepsis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Mihai G. Netea, Prof. dr.

  Radboud University Medical Center

  STUDY DIRECTOR

• Wouter A. van der Heijden, dr.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

• Peter Pickkers, Prof. dr.

  Radboud University Medical Center

  STUDY DIRECTOR

Central Study Contacts

Tristan Couwenbergh

CONTACT

+31613456047; tristan.couwenbergh@radboudumc.nl

Wouter A. van der Heijden, dr.

CONTACT

Wouter.vanderHeijden@radboudumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 9, 2025
• Study Start: November 3, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 9, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)