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RecruitingNCT04203979Updated Mar 19, 2026

Sepsis: From Syndrome to Personalized Care

An observational study in Sepsis Syndrome, Sepsis and Sepsis, Severe, sponsored by Oslo University Hospital. Recruiting at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-19.

Sponsored by Oslo University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,950
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Sepsis Syndrome
  • Sepsis
  • Sepsis, Severe
  • Septic Shock
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adults with suspected sepsis or other severe conditions in the Emergency department.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,950 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes
Biospecimen retention
Samples with dna
05

What researchers measure

Primary outcomes

  1. Number of sepsis patient with elevated plasma-calprotectin

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

    Time frame: One year

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

    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.

    Time frame: One year

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

    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).

    Time frame: One year

Secondary outcomes

  1. Concentration of biomarkers in blood.

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

    Time frame: One year

Other outcomes

  1. Sepsis endotypes

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

    Time frame: 3 years

  2. Exteranal validation of sepsis endotypes

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

    Time frame: 3 years

  3. Temperal profile of host response

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

    Time frame: 3 years

  4. E. coli influences the host respons

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

    Time frame: 3 years

  5. Impact on microbiome

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

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

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • Christensen EE, Binde C, Leegaard M, Tonby K, Dyrhol-Riise AM, Kvale D, Amundsen EK, Holten AR. DIAGNOSTIC ACCURACY AND ADDED VALUE OF INFECTION BIOMARKERS IN PATIENTS WITH POSSIBLE SEPSIS IN THE EMERGENCY DEPARTMENT. Shock. 2022 Oct 1;58(4):251-259. doi: 10.1097/SHK.0000000000001981. Epub 2022 Sep 6. PubMed 36130401 ↗

Individual participant data

Plan to share: Undecided

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Registry details

Key details

Study ID
NCT04203979
Lead sponsor
Oslo University Hospital
Responsible party
Aleksander Rygh Holten (Principal Investigator, Oslo University Hospital) — Principal investigator
First posted
Dec 18, 2019
Start date
Jan 6, 2020
Primary completion
Jul 31, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Mar 19, 2026

Study contacts

Aleksander R Holten, PhD
Contact
aleksander.holten@gmail.com
+4799275784
Aleksander R Holten, PhD
principal investigator · Oslo University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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