Mortality of Sepsis in Swedish Intensive Care Units 2008-2016

Sepsis Clinical Trial

Official title:

Mortality of Sepsis in Swedish Intensive Care Units 2008-2016

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03489447
• Other study ID #: 2015/519
• Status: Completed
• First received: March 21, 2018
• Last updated: April 4, 2018
• Start date: January 1, 2008
• Est. completion date: October 25, 2017

Study information

• Verified date: April 2018
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Changes in mortality during the period are studied.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252245
• Est. completion date: October 25, 2017
• Est. primary completion date: October 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Other:
• ICU care
exposure to ICU treatment with or without diagnosed sepsis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30 day mortality	mortality within 30 days after admission to ICU	From the day of ICU admission until death of any cause , whichever came first, assessed up to 30 days.
Primary	90 day mortality	mortality within 90 days after admission to ICU	From the day of ICU admission until death of any cause, whichever came first, assessed up to day 90.
Primary	365 day mortality	mortality within 365 days after admission to ICU	From the day of ICU admission until death of any cause , whichever came first, assessed up to day 365.
Secondary	hospital mortality	mortality before discharge from hospital after admission to ICU	From the day of ICU admission until death of any cause or day of hospital discharge, whichever came first, assessed up to day 365.
Secondary	ICU length of stay		From the day of ICU admission until death of any cause or day of ICU discharge, whichever came first, assessed up to day 365.
Secondary	hospital length of stay		From the day of ICU admission until death of any cause or day of hospital discharge , whichever came first, assessed up to day 365.