blood sampling / Sepsis · Observational Study

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

ClinicalTrials.gov · August 14, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registry entry for an active observational study recruiting sepsis patients to characterize immune phenotypes (immunotypes) at three timepoints and correlate them with short- and long-term clinical outcomes. No results are posted; the record describes study rationale, design, and planned analyses only. Clinicians and researchers should monitor for results reporting.

What was studied

Observational. Sepsis; age from 18 Years. Intervention: blood sampling. n = 400. 1 site: Netherlands.

Key findings

Safety

Primary outcomes are immunotype classification measures; clinical benefit or harm has not been evaluated. Long-term clinical outcomes (infection, cardiovascular disease, mortality) are stated as study aims but no prospective endpoint definitions or statistical analysis plan is disclosed in this record.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is an active observational registry study with no results yet posted; it describes planned enrollment and immunophenotyping outcomes but carries no outcome data, effect estimates, or clinical evidence.

Study design

As stated by the source record.

MethodsCohort model. Prospective time perspective. Primary outcome measures: Classification of hospitalized sepsis patients into distinct immunotypes. (assessed at Day 0 (within 48 hours of intensive care unit admission or start of sepsis)); Classification of hospitalized sepsis patients into distinct immunotypes. (assessed at Day 3 (defined as 3 days after day 0)); Classification of hospitalized sepsis patients into distinct immunotypes. (assessed at At hospital discharge.)

DesignObservational

PopulationSepsis; age from 18 Years

Sample size400

Interventionblood sampling

Setting1 site: Netherlands

Reported figures

Quoted from the source exactly as published.

Planned enrollment400

Primary outcome measure 1Classification of hospitalized sepsis patients into distinct immunotypes, Day 0 (within 48 hours of ICU admission or start of sepsis)

Primary outcome measure 2Classification of hospitalized sepsis patients into distinct immunotypes, Day 3 (defined as 3 days after day 0)

Primary outcome measure 3Classification of hospitalized sepsis patients into distinct immunotypes, at hospital discharge

Follow-up durationOne year after return home

Caveats

This is a registry record; no results or outcome data are reported.
Study is actively recruiting; enrollment and follow-up status unknown.
Primary outcomes are immunotype classification measures; clinical benefit or harm has not been evaluated.
Long-term clinical outcomes (infection, cardiovascular disease, mortality) are stated as study aims but no prospective endpoint definitions or statistical analysis plan is disclosed in this record.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Observational cohort design with prospective blood sampling at defined timepoints.

Directness

moderate

Measures immunotypes via blood biomarkers; clinical outcomes and long-term harm not yet defined.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

insufficient

Study is ongoing; blinding, loss to follow-up, and analytical approach not yet disclosed.

Sample adequacy

moderate

Planned enrollment 400 participants; adequate for exploratory immunotype classification.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07273344). This is a study registration, not published results. Lead sponsor: Radboud University Medical Center. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 400 participants (ESTIMATED). Conditions: Sepsis. Interventions: OTHER: blood sampling. Primary outcome measures: 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.. 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.

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blood samplingRadboud University Medical CenterSepsisNCT07273344