A Study on How the Immune System Responds to Sepsis and Its Long-term Effects
ConditionSepsis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRadboud University Medical Center
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial population
ICU or medium care patients diagnosed with sepsis, as defined by the Sepsis-3 criteria, from the Radboudumc, Canisius Wilhelmina Ziekenhuis, Rijnstate Ziekenhuis, Jeroen Bosch Ziekenhuis, Gelre Ziekenhuis Apeldoorn, Catharina Ziekenhuis or Slingeland Ziekenhuis.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
blood sampling
Other interventionThis study involves no interventions beyond scheduled blood collection.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Classification of hospitalized sepsis patients into distinct immunotypes.
Time frame
Day 0 (within 48 hours of intensive care unit admission or start of sepsis)2
Classification of hospitalized sepsis patients into distinct immunotypes.
Time frame
Day 3 (defined as 3 days after day 0)3
Classification of hospitalized sepsis patients into distinct immunotypes.
Time frame
At hospital discharge.Secondary outcomes
1
Detection of persistent immunotypes at following hospital discharge.
Time frame
Three months after hospital discharge.2
Detection of persistent immunotypes at following hospital discharge.
Time frame
Twelve months after hospital discharge.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Radboud University Medical Center
Lead sponsor
The Dutch Research Council (NWO)
Collaborator
Source ClinicalTrials.gov