NCT03489447

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
252,245

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 5, 2018

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

9.8 years

First QC Date

March 21, 2018

Last Update Submit

April 4, 2018

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • hospital mortality

    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.

Study Arms (2)

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

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

Interventions

exposure to ICU treatment with or without diagnosed sepsis

Non-sepsis groupSepsis group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult general ICU patients included in the Swedish Intensive Care Registry 2008-01-01 to 2016-10-18.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Miklós Lipcsey, PhD

    Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2018

First Posted

April 5, 2018

Study Start

January 1, 2008

Primary Completion

October 25, 2017

Study Completion

October 25, 2017

Last Updated

April 5, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share