Sepsis Blood poisoning
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a participant must meet all of the following criteria:-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.
Exclusion criteria
Exclusion criteria: A potential participant who meets any of the following criteria will be excluded from participation in this study:-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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical parameters During admission (from electronic patient records)-Demographics-Comorbidities-Sequential Organ Failure Assessment (SOFA)-2 score-Acute Physiology and Chronic Health Evaluation (APACHE) IV score-Microbiological and laboratory data (including creatinine and hemocytometry)-Administered therapy and required interventions-Length of ICU or MC stay-Survival and hospital discharge dateAfter discharge (from phone interview by a member of the research team)-Hospital re-admission-Infectious events: infection-related death, number and type of infections post discharge (pneumonia, urinary tract infections, skin and soft tissue infections, bloodstream infections)-Cardiovascular events: cardiovascular-related death, myocardial infarction, coronary revascularization, new or worsening heart failure, new or worsening arrhythmias, stroke, transient ischemic attack-Clinical frailty score-1-year outcome-SurvivalAfter discharge(by email)-Validated patient-reported outcome questionnaires-Amsterdam Cognition ScanAfter discharge (from blood sample)-Creatinine*-Hemocytometry *After discharge(from Vektis)-Post-discharge healthcare utilization data (including costs, volume, and type of care) from the participant’s insurer.Immunological and molecular parameters from blood samplesPeripheral blood mononuclear cell(PBMC)-CD34+ hematopoietic stem cell (HSC) isolation-Immunological analyses (e.g. expression of immune markers on the cell membrane and cytokine production capacity)Transcriptomics*-RNA-sequencing Proteomics*-Proteome profilingMetabolomics*-Unbiased metabolomics analysisEpigenetics*-Chromatin accessibility analysis by ATAC-sequencing-DNA methylation | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicable. | — |
Countries
Netherlands
Contacts
Radboud Universitair Medisch Centrum