Sepsis SyndromeNCT03956043
Diagnostic Accuracy in Sepsis
An observational study of Sepsis Syndrome, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The sepsis syndrome has recently been more stringently defined as "a life-threatening organ dysfunction caused by a dysregulated host response to infection". Clinical and paraclinical tools are investigated for their ability to adequately recognize sepsis early. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis Syndrome
- How many people
- 1,989 participants
- Where
- 1 siteNorway
- Study dates
- 15 May 2017to 15 Dec 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Oslo University Hospital is a secondary and tertiary Hospital in Norway's largest city Oslo. The Emergency Department treats about 30 000 patient per year, including approximately 500 with suspected sepsis.
Who may be able to join
- Patients >18 years old with suspected sepsis in the Emergency Department of Oslo University Hospital Oslo
Who cannot join
- Non
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Accuracy of Clinical and Paraclinical Tools in Sepsis
The sepsis syndrome has recently been more stringently defined as "a life-threatening organ dysfunction caused by a dysregulated host response to infection". Clinical and paraclinical tools are investigated for their ability to adequately recognize sepsis early.
- Conditions
- Sepsis Syndrome
- Medical subject headings
- Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected sepsis in Emergency Department | Patients with suspected sepsis treated by the sepsis emergency team or the medical emergency team in the Emergency Department of Oslo University Hospital Oslo are included prospectively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy in sepsis
Sensitivity, specificity, predictive values, AUC of clinical criteria of sepsis in the Emergency department, compared to post hoc assesment
Measured: within 90 days after inclusion
Prognostic accuracy in sepsis
Sensitivity, specificity, predictive values, AUC of clinical criteria of sepsis in the Emergency department, compared to in hospital, 30 and 90 days mortality
Measured: 90 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start15 May 2017
- Primary completion15 Sep 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sepsis SyndromeStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,989 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksander Rygh Holten, Oslo University Hospital
- Investigators
- Aleksander R Holten, MD, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956043
- Sponsor's protocol ID
- Sepsis-OUH
- Status last verified
- Mar 2025
- First submitted
- 15 May 2019
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Clinical and Paraclinical Tools in Sepsis
- ClinicalTrials.gov ID
- NCT03956043
- Acronym / sponsor ID
- Sepsis-OUH
- Conditions
- Sepsis Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,989 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 20 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The sepsis syndrome has recently been more stringently defined as "a life-threatening organ dysfunction caused by a dysregulated host response to infection". Clinical and paraclinical tools are investigated for their ability to adequately recognize sepsis early.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected sepsis in Emergency Department | – | –Patients with suspected sepsis treated by the sepsis emergency team or the medical emergency team in the Emergency Department of Oslo University Hospital Oslo are included prospectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Oslo University Hospital is a secondary and tertiary Hospital in Norway's largest city Oslo. The Emergency Department treats about 30 000 patient per year, including approximately 500 with suspected sepsis.
Key inclusion criteria (1 listed)
- Patients >18 years old with suspected sepsis in the Emergency Department of Oslo University Hospital Oslo
Key exclusion criteria (1 listed)
- Non
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic accuracy in sepsis
Time frame: within 90 days after inclusion
Sensitivity, specificity, predictive values, AUC of clinical criteria of sepsis in the Emergency department, compared to post hoc assesment
Prognostic accuracy in sepsis
Time frame: 90 days after inclusion
Sensitivity, specificity, predictive values, AUC of clinical criteria of sepsis in the Emergency department, compared to in hospital, 30 and 90 days mortality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Derived from this study: PubMed 36130401Christensen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aleksander R Holten, MD, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis Syndrome, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy in sepsis (time frame: within 90 days after inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03956043, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.