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A study on how the immune system responds to sepsis and its long-term effects.

A systems immunology approach to characterize the immune response in sepsis and its long-term complications. - HEAL-SEPSIS

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57957
Enrollment
400
Registered
2025-06-03
Start date
2025-11-03
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis Blood poisoning

Interventions

Not applicable. This study involves no interventions beyond scheduled blood collection.&nbsp

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime 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

MeasureTime frame
Not applicable. 

Countries

Netherlands

Contacts

Public ContactW.A. van der Heijden

Radboud Universitair Medisch Centrum

healsepsis.a.ig@radboudumc.nl+31616149200

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 11, 2026