Mortality of Sepsis in Swedish Intensive Care Units 2008-2016

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.

Study Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Other: ICU care

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 Type: Observational
• Enrollment (Actual): 252245

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: ICU care; exposure to ICU treatment with or without diagnosed sepsis
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	Other: ICU care; exposure to ICU treatment with or without diagnosed sepsis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: Uppsala University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2008
• Primary Completion (ACTUAL): October 25, 2017
• Study Completion (ACTUAL): October 25, 2017

Study Registration Dates

• First Submitted: March 21, 2018
• First Submitted That Met QC Criteria: April 4, 2018
• First Posted (ACTUAL): April 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2018
• Last Update Submitted That Met QC Criteria: April 4, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: 2015/519

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No