SepsisNCT03489447
Mortality of Sepsis in Swedish Intensive Care Units 2008-2016
An observational study of Sepsis, run by Uppsala University.
Trial summary
A study of short and long term mortality in patients treated with or without a diagnosis of sepsis in Swedish intensive care units (ICU) 2008 - 2016. The cohort is characterized with regard to chronic comorbidity, severity of acute illness and demographic factors, and outcome is adjusted for these factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- ICU care
- How many people
- 252,245 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2008to 25 Oct 2017
- 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: All adult general ICU patients included in the Swedish Intensive Care Registry 2008-01-01 to 2016-10-18.
Who may be able to join
- Admission to a Swedish general ICU (excluding specialized cardiothoracic, neurosurgical, pediatric and burns units) between 2008-01-01 and 2016-10-18
- Episode registered in Swedish Intensive Care Registry
Who cannot join
- Age < 18 years
- Readmission (only first episode during the period included)
About this study
A study of short and long term mortality in patients treated with or without a diagnosis of sepsis in Swedish intensive care units (ICU) 2008 - 2016. The cohort is characterized with regard to chronic comorbidity, severity of acute illness and demographic factors, and outcome is adjusted for these factors. Changes in mortality during the period are studied.
Read the detailed description
All adult patients admitted to a general ICU included in the Swedish Intensive Care Registry (a majority of all ICUs in Sweden) between 2008-01-01 and 2016-10-18 are followed for one year and any deaths are registered. Data on illness severity scores, age, sex, admitting hospital and duration of ICU stay are recovered. Data are linked with the inpatient registry of the Swedish Board of Health and Welfare (Socialstyrelsen), and any discharge diagnoses from the last 5 years preceding ICU admission are recovered. These are used to assess chronic comorbidity.
Mortality, adjusted for severity of illness, comorbidity and patient factors, is studied and any changes over time during the inclusion period are assessed.
The data in the Swedish ICU Registry are entered by the treating ICU physicians and include severity of illness (Simplified Acute Physiology Score (SAPS)3), selected chronic comorbidity, sex and date of birth, ICU stay and selected interventions and complications. Relevant International Classification of Diseases (ICD)-10 diagnoses are required and assessment of the occurrence of severe sepsis or septic shock, during the inclusion period defined according to the American College of Chest Physicians/Society of Critical Care Medicine (ACCP/SCCM) (sepsis 2) criteria, is mandatory when entering data.
- Conditions
- Sepsis
- Being tested
- ICU care
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICU careOther
exposure to ICU treatment with or without diagnosed sepsis
| Study group | Role | What they receive |
|---|---|---|
| Sepsis group | All adult (>= 18 years) patients with a diagnosis of sepsis included in the Swedish ICU Registry between 2008-01-01 and 2016-10-18 Receives: Other: ICU care | |
| Non-sepsis group | All adult (>=18 years) patients without a diagnosis of sepsis included in the Swedish ICU Registry between 2008-01-01 and 2016-10-18 Receives: Other: ICU care |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 day mortality
mortality within 30 days after admission to ICU
Measured: From the day of ICU admission until death of any cause , whichever came first, assessed up to 30 days.
90 day mortality
mortality within 90 days after admission to ICU
Measured: From the day of ICU admission until death of any cause, whichever came first, assessed up to day 90.
365 day mortality
mortality within 365 days after admission to ICU
Measured: From the day of ICU admission until death of any cause , whichever came first, assessed up to day 365.
Secondary outcomes (3)
hospital mortality
mortality before discharge from hospital after admission to ICU
Measured: From the day of ICU admission until death of any cause or day of hospital discharge, whichever came first, assessed up to day 365.
ICU length of stay
Measured: From the day of ICU admission until death of any cause or day of ICU discharge, whichever came first, assessed up to day 365.
hospital length of stay
Measured: From the day of ICU admission until death of any cause or day of hospital discharge , whichever came first, assessed up to day 365.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start1 Jan 2008
- Primary completion25 Oct 2017
- Study completion25 Oct 2017
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 SepsisStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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
- 252,245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miklós Lipcsey, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489447
- Sponsor's protocol ID
- 2015/519
- Status last verified
- Apr 2018
- First submitted
- 21 Mar 2018
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Strandberg G, Walther S, Agvald Ohman C, Lipcsey M. Mortality after Severe Sepsis and Septic Shock in Swedish Intensive Care Units 2008-2016-A nationwide observational study. Acta Anaesthesiol Scand. 2020 Aug;64(7):967-975. doi: 10.1111/aas.13587. Epub 2020 Apr 27.
PubMed 32232853
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mortality of Sepsis in Swedish Intensive Care Units 2008-2016
- ClinicalTrials.gov ID
- NCT03489447
- Acronym / sponsor ID
- 2015/519
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 252,245 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 25 Oct 2017 (actual)
- Study completion
- 25 Oct 2017 (actual)
- First posted
- 5 Apr 2018 (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 study of short and long term mortality in patients treated with or without a diagnosis of sepsis in Swedish intensive care units (ICU) 2008 - 2016. The cohort is characterized with regard to chronic comorbidity, severity of acute illness and demographic factors, and outcome is adjusted for these factors. Changes in mortality during the period are studied.
Detailed description
All adult patients admitted to a general ICU included in the Swedish Intensive Care Registry (a majority of all ICUs in Sweden) between 2008-01-01 and 2016-10-18 are followed for one year and any deaths are registered. Data on illness severity scores, age, sex, admitting hospital and duration of ICU stay are recovered. Data are linked with the inpatient registry of the Swedish Board of Health and Welfare (Socialstyrelsen), and any discharge diagnoses from the last 5 years preceding ICU admission are recovered. These are used to assess chronic comorbidity.
Mortality, adjusted for severity of illness, comorbidity and patient factors, is studied and any changes over time during the inclusion period are assessed.
The data in the Swedish ICU Registry are entered by the treating ICU physicians and include severity of illness (Simplified Acute Physiology Score (SAPS)3), selected chronic comorbidity, sex and date of birth, ICU stay and selected interventions and complications. Relevant International Classification of Diseases (ICD)-10 diagnoses are required and assessment of the occurrence of severe sepsis or septic shock, during the inclusion period defined according to the American College of Chest Physicians/Society of Critical Care Medicine (ACCP/SCCM) (sepsis 2) criteria, is mandatory when entering data.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis group | – | Other: ICU careAll adult (>= 18 years) patients with a diagnosis of sepsis included in the Swedish ICU Registry between 2008-01-01 and 2016-10-18 |
| Non-sepsis group | – | Other: ICU careAll adult (>=18 years) patients without a diagnosis of sepsis included in the Swedish ICU Registry between 2008-01-01 and 2016-10-18 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult general ICU patients included in the Swedish Intensive Care Registry 2008-01-01 to 2016-10-18.
Key inclusion criteria (2 listed)
- Admission to a Swedish general ICU (excluding specialized cardiothoracic, neurosurgical, pediatric and burns units) between 2008-01-01 and 2016-10-18
- Episode registered in Swedish Intensive Care Registry
Key exclusion criteria (2 listed)
- Age < 18 years
- Readmission (only first episode during the period included)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICU careexposure to ICU treatment with or without diagnosed sepsis | Other | Non-sepsis group, Sepsis group |
Primary outcome
30 day mortality
Time frame: From the day of ICU admission until death of any cause , whichever came first, assessed up to 30 days.
mortality within 30 days after admission to ICU
90 day mortality
Time frame: From the day of ICU admission until death of any cause, whichever came first, assessed up to day 90.
mortality within 90 days after admission to ICU
365 day mortality
Time frame: From the day of ICU admission until death of any cause , whichever came first, assessed up to day 365.
mortality within 365 days after admission to ICU
3 secondary outcomes
hospital mortality
Time frame: From the day of ICU admission until death of any cause or day of hospital discharge, whichever came first, assessed up to day 365.
ICU length of stay
Time frame: From the day of ICU admission until death of any cause or day of ICU discharge, whichever came first, assessed up to day 365.
hospital length of stay
Time frame: From the day of ICU admission until death of any cause or day of hospital discharge , whichever came first, assessed up to day 365.
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 5 Apr 2018.
- Derived from this study: PubMed 32232853Strandberg G, Walther S, Agvald Ohman C, Lipcsey M. Mortality after Severe Sepsis and Septic Shock in Swedish Intensive Care Units 2008-2016-A nationwide observational study. Acta Anaesthesiol Scand. 2020 Aug;64(7):967-975. doi: 10.1111/aas.13587. Epub 2020 Apr 27.
- 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.
Miklós Lipcsey, PhD principal investigator
Uppsala University
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Uppsala University.
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 2 inclusion and 2 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 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
30 day mortality (time frame: From the day of ICU admission until death of any cause , whichever came first, assessed up to 30 days.). The study lists 3 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 NCT03489447, 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 5 Apr 2018.