Clinical trial NCT03489447: Mortality of Sepsis in Swedish Intensive Care Units 2008-2016
Official title: Mortality of Sepsis in Swedish Intensive Care Units 2008-2016
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2018-04-05
Enrollment: 252245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult general ICU patients included in the Swedish Intensive Care Registry 2008-01-01 to 2016-10-18.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Age \< 18 years
* Readmission (only first episode during the period included)

Primary outcomes:
measure: 30 day mortality
timeFrame: From the day of ICU admission until death of any cause , whichever came first, assessed up to 30 days.
measure: 90 day mortality
timeFrame: From the day of ICU admission until death of any cause, whichever came first, assessed up to day 90.
measure: 365 day mortality
timeFrame: From the day of ICU admission until death of any cause , whichever came first, assessed up to day 365.
Secondary outcomes:
measure: hospital mortality
timeFrame: From the day of ICU admission until death of any cause or day of hospital discharge, whichever came first, assessed up to day 365.
measure: ICU length of stay
timeFrame: From the day of ICU admission until death of any cause or day of ICU discharge, whichever came first, assessed up to day 365.
measure: hospital length of stay
timeFrame: From the day of ICU admission until death of any cause or day of hospital discharge , whichever came first, assessed up to day 365.
Other outcomes:
Locations:
Study officials:
affiliation: Uppsala University
name: Miklós Lipcsey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.