Sepsis: From Syndrome to Personalized Care

NCT04203979 | Recruiting

• 1 other identifier: Sepsis-OUH-2
• Study Type: observational
• Target: 1,950
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis Syndrome; Sepsis; Sepsis, Severe; Septic Shock

Outcome Measures

Primary Outcomes (3)

• Number of sepsis patient with elevated plasma-calprotectin

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

  One year

• 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.

  One year

• 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).

  One year

Secondary Outcomes (1)

• Concentration of biomarkers in blood.

  One year

Other Outcomes (5)

• Sepsis endotypes

  3 years

• Exteranal validation of sepsis endotypes

  3 years

• Temperal profile of host response

  3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, Norway

RECRUITING

Related Publications (1)

• 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.

  PMID: 36130401 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Samples will be collected, together with routine blood samples, from patients with suspected sepsis shortly after arrival at the Emergency department, before antibiotics are given. Calprotectin, CRP and leukocytes wil be analysed in the routine laboratory. Blood will be biobanked for other analyses

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome; Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Infections

Study Officials

• Aleksander R Holten, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleksander R Holten, PhD

CONTACT

+4799275784; aleksander.holten@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 18, 2019
• Study Start: January 6, 2020
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

NO (1)