SepsisNCT04055727
Sepsis at Södersjukhuset-Adherence to Treatment Guidelines
An observational study of Sepsis, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
A retrospective single-center study with patients with suspected sepsis admitted to the Emergency Department at Södersjukhuset during a period of two years. The aim is to describe the association between adherence to treatment guidelines, gender, incidence and mortality for patients with sepsis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- How many people
- 11,000 participants
- Where
- 1 siteSweden
- Study dates
- 7 Mar 2019to 1 Sep 2022
- 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: Patients admitted to the emergency department at Södersjukhuset
Who may be able to join
- Patients admitted to the Emergency Department at Södersjukhuset with suspicion of sepsis defined as blood cultures taken and intravenous antibiotics of type beta-lactam or aminoglycoside prescribed within 48 hours of admission.
Who cannot join
- Patients transferred from other hospitals or treatment clinics.
Trial locations and contacts
1 site in 1 country.
About this study
A retrospective single-center study with patients with suspected sepsis admitted to the Emergency Department at Södersjukhuset during a period of two years. The aim is to describe the association between adherence to treatment guidelines, gender, incidence and mortality for patients with sepsis.
Read the detailed description
In this single-center study, patients with suspected sepsis admitted to the Emergency Department at Södersjukhuset during a period of two years will be included. About 11,000 patients will be included. Patient data including described sepsis symptoms will be drawn from the electronic medical record, TakeCare and Clinisoft. Logistic regression analysis will adjust for age, gender, comorbidity according to Charlson score, vital signs, with preliminary focus of infection (pneumonia, urinary tract infection, abdominal, other, unknown). The Surviving Sepsis guidelines for the time period are: 3-hour bundle including lactate measurement, obtaining blood culture, fluid treatment if hypotensive and administration of broad-spectrum antibiotics. The 6-hour bundles with administration of vasopressors if needed, remeasure lactate if elevated, with persistent hypotension re-asses volume status and tissue perfusion. Time zero is defined as the admission time to the emergency department. The aim is to describe the association between adherence to treatment guidelines, gender, incidence and mortality for patients with sepsis.
- Conditions
- Sepsis
- Keywords
- treatment
- Medical subject headings
- Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
Gender differences in 90-day mortality
Gender differences in percentage of patients who died before day 90
Measured: 90 days
Secondary outcomes (2)
Association between adherence to treatment guidelines and mortality
Association between number of completed sepsis bundles and mortality
Measured: 90 days
Incidence of sepsis
Number of patients admitted to the Emergency Department at Södersjukhuset during the study period comparing to the hospitals catchment area
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start7 Mar 2019
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Retrospective
- Enrolment
- 11,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katarina Bohm, Karolinska Institutet
- Investigators
- Katarina Bohm, Ass Prof, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055727
- Sponsor's protocol ID
- SepsisSoS
- Status last verified
- Nov 2021
- First submitted
- 12 Aug 2019
- Last updated
- 12 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sepsis at Södersjukhuset-Adherence to Treatment Guidelines
- ClinicalTrials.gov ID
- NCT04055727
- Acronym / sponsor ID
- SepsisSoS
- Conditions
- Sepsis
- Keywords
- treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 11,000 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 14 Aug 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.
A retrospective single-center study with patients with suspected sepsis admitted to the Emergency Department at Södersjukhuset during a period of two years. The aim is to describe the association between adherence to treatment guidelines, gender, incidence and mortality for patients with sepsis.
Detailed description
In this single-center study, patients with suspected sepsis admitted to the Emergency Department at Södersjukhuset during a period of two years will be included. About 11,000 patients will be included. Patient data including described sepsis symptoms will be drawn from the electronic medical record, TakeCare and Clinisoft. Logistic regression analysis will adjust for age, gender, comorbidity according to Charlson score, vital signs, with preliminary focus of infection (pneumonia, urinary tract infection, abdominal, other, unknown). The Surviving Sepsis guidelines for the time period are: 3-hour bundle including lactate measurement, obtaining blood culture, fluid treatment if hypotensive and administration of broad-spectrum antibiotics. The 6-hour bundles with administration of vasopressors if needed, remeasure lactate if elevated, with persistent hypotension re-asses volume status and tissue perfusion. Time zero is defined as the admission time to the emergency department. The aim is to describe the association between adherence to treatment guidelines, gender, incidence and mortality for patients with sepsis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the emergency department at Södersjukhuset
Key inclusion criteria (1 listed)
- Patients admitted to the Emergency Department at Södersjukhuset with suspicion of sepsis defined as blood cultures taken and intravenous antibiotics of type beta-lactam or aminoglycoside prescribed within 48 hours of admission.
Key exclusion criteria (1 listed)
- Patients transferred from other hospitals or treatment clinics.
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
Gender differences in 90-day mortality
Time frame: 90 days
Gender differences in percentage of patients who died before day 90
2 secondary outcomes
Association between adherence to treatment guidelines and mortality
Time frame: 90 days
Incidence of sepsis
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2021.
- 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.
Katarina Bohm, Ass Prof principal investigator
Karolinska Institutet
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, run by Karolinska Institutet at 1 site in Sweden.
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: status not confirmed, as of the sponsor's last update on 12 Nov 2021. 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 Sweden. 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?
Results are not available in the source record.
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?
Gender differences in 90-day mortality (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Nov 2021; AzTrials last refreshed its copy on 7 Nov 2026.