Actively Recruiting

Age: 18Years +
All Genders
ID07273344

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

Led by Radboud University Medical Center · Updated on 2025-12-09

400

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

R

Radboud University Medical Center

Lead Sponsor

D

Dutch Research Council

Collaborating Sponsor

AI-Summary

What this Trial Is About

Sepsis is a serious condition caused by an infection that disrupts the immune system, potentially leading to organ damage or failure. This research aims to understand the different immune response types, called immunotypes, that occur during and after sepsis. By studying these immunotypes and their effects on short- and long-term health, researchers hope to improve patient care and treatment selection in the future. This is a multicenter, prospective observational study involving 400 adult patients admitted to intensive or medium care units with sepsis. Blood samples will be collected at multiple times: within 48 hours of ICU admission, three days later, at hospital discharge, and at three and twelve months after discharge. The study involves no treatments beyond blood collection, which will be coordinated with routine care to reduce extra procedures. Follow-up assessments will include questionnaires or phone interviews. Participants will be monitored from ICU admission through one year after returning home. Researchers will analyze blood samples and clinical data to classify patients into immunotypes and observe how these relate to health outcomes. The primary outcomes focus on immune response classification at early ICU admission, day 3, and discharge. Secondary outcomes assess persistent immunotypes at three and twelve months post-discharge. The study is designed to minimize risks and burden, with no direct benefit to participants but potential future benefits for sepsis diagnosis and treatment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults (≥18 years).
  • Diagnosed with sepsis according to Sepsis-3 criteria, including suspected or documented infection with organ dysfunction (SOFA-2 score ≥2 for new admissions or an increase of 2 or more points for hospitalized patients).
Not Eligible

You will not qualify if you...

  • Known chemotherapy-induced or long-term neutropenia.
  • Known CD4 counts less than 400 cells/µL.
  • History of primary immunodeficiency.
  • Chronic corticosteroid use at or above 0.4 mg/kg prednisone equivalent for more than 15 days.
  • Current use of biologic medications.
  • Solid organ transplant recipients.
  • Recipients of allogeneic bone marrow transplants.

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - From ICU/medium care admission within 48 hours to hospital discharge

Participants diagnosed with sepsis are evaluated and blood samples are collected to classify immune response types.

3 visits during hospital stay: day 0 (within 48 hours of admission), day 3 (±1 day), and at hospital discharge (±2 days)

Long-term Monitoring

Duration - Up to 12 months post-discharge

Participants are observed for long-term immune response and health outcomes following hospital discharge.

2 visits at 3 and 12 months post-discharge, including blood collection and questionnaires or phone interviews

Trial Site Locations

Total: 1 location

1

Radboud University Medical Center

Nijmegen, Gelderland, Netherlands

Actively Recruiting

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Research Team

T

Tristan Couwenbergh

W

Wouter A. van der Heijden, dr.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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