Mortality of Sepsis in Swedish Intensive Care Units 2008-2016

NCT ID: NCT03489447

Last Updated: 2018-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

252245 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-01

Study Completion Date

2017-10-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Sepsis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

ICU care

Intervention Type OTHER

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

ICU care

Intervention Type OTHER

exposure to ICU treatment with or without diagnosed sepsis

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ICU care

exposure to ICU treatment with or without diagnosed sepsis

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Uppsala University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Miklós Lipcsey, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 32232853 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2015/519

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Early Prediction of Sepsis
NCT04570618 COMPLETED NA
Septic Shock em Steroids
NCT01047670 UNKNOWN PHASE2/PHASE3
Sepsis in the ICU-II
NCT04695119 RECRUITING
Lactate Kinetics in Septic Shock
NCT05349370 RECRUITING NA