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NCT Number: NCT04203979

Sepsis: From Syndrome to Personalized Care

This is a prospective, observational study designed to examine the performance of biomarkers, molecular biological methods and other analysis in blood from patient with suspected sepsis in the Emergency department, as well as identidying novel sepsis endotypes. Around 1500 patients will be enrolled.

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Key information

Conditions

Sepsis Syndrome Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Sepsis, Severe Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital

Oslo, Norway

Location status: Recruiting

Location contact

Aleksander R Holten, MD, PhD

CONTACT

[email protected]

+47 99275784

About this study

The study will prospectively include adult patients (>18 years) with suspected sepsis admitted to Oslo University Hospital, Ullevål (OUH-Ullevål). Patients admitted to the emergency department and managed by the medical rapid response team or the sepsis rapid response team are considered eligible for inclusion. Informed consent will be collected at the emergency department if possible, or within few days, by a clinical investigator or a study nurse. The investigators aim to include 1500 patients treated by the Sepsis Rapid Response Team or Medical Emergency team for possible sepsis. Patients classified to have had other conditions than sepsis in the post hoc assessment will be used as controls. The inclusion period will be 5 years.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • admitted to emergency department OUH, Ullevål.
  • managed by the medical rapid response team or the sepsis rapid response team

Exclusion criteria

  • Not given informed consent by patient or next of kin (if patient is not able to)

Treatment and study plan

Primary outcomes

  1. Number of sepsis patient with elevated plasma-calprotectin

    Time frame: One year

    Sensitivity of plasma-calprotectin for detecting infections in critical ill medical patients in the Emergency department.

  2. Area under the curve receiver operator characteristic (AUC - ROC) for inflammation biomarkers for detecting infection in critically ill patients.

    Time frame: One year

    Comparing area under the curve receiver operator characteristic (AUC - ROC) for calprotectin, pro-calcitonin, CRP and other biomarkers for detecting infections in critically ill patients in the Emergency department.

  3. Number of sepsis patient with bacterial DNA detected in blood by molecular biological tests.

    Time frame: One year

    The performance of rapid molecular biological tests for detecting bacterial DNA in full blood in critically ill medical patients, compared to current state-of-the art diagnostics (blood culture).

Secondary outcomes

  1. Concentration of biomarkers in blood.

    Time frame: One year

    Explore how the concentration of biomarkers of inflammation change during the course of the disease.

Other outcomes

  1. Sepsis endotypes

    Time frame: 3 years

    Comprehensively characterize the host response to infection in patients presenting to the ED with sepsis and identify endotypes by unsupervised machine learning methods

  2. Exteranal validation of sepsis endotypes

    Time frame: 3 years

    Externally validate host response profiles and multi-omic sepsis endotypes in two international cohorts.

  3. Temperal profile of host response

    Time frame: 3 years

    Describe how host response profiles develop in the days after hospital admission and initiation of treatment.

  4. E. coli influences the host respons

    Time frame: 3 years

    Characterize how genetic variation within E. coli influences the host response to sepsis

  5. Impact on microbiome

    Time frame: At hospital admittance, day 3 and day 7.

    Impact from infection and antimicrobial treatment on gut and respiratory tract microbiome

Study contacts

Contact information is provided by the study sponsor or research team.

Aleksander R Holten, PhD

CONTACT

[email protected]

+4799275784

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Dec 18, 2019
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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