NCT05394961

Brief Summary

Medical and socioeconomic data are extracted from the Swedish Intensive Care Registry (SIR), the Swedish National Patient Registry and Statistics Sweden for all adult patients admitted to in Swedish intensive care units between 2014-01-01 and 2020-12-31 with a diagnosis of sepsis and/or acute respiratory distress syndrome (ARDS) and/or coronavirus 19 (COVID-19) infection, and registered in SIR. The impact of demographic and socioeconomic factors on decisions to withhold or withdraw intensive care, and on mortality, are studied and statistically adjusted for level of chronic comorbidity and severity of acute illness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33,256

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

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

August 26, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 27, 2022

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

Same day

First QC Date

May 23, 2022

Last Update Submit

May 23, 2022

Conditions

Keywords

critical carelimitations of carecritical illnessintensive care unit

Outcome Measures

Primary Outcomes (1)

  • Decision to withhold or withdraw intensive care

    Registered decision

    During ICU care

Secondary Outcomes (2)

  • 30 day mortality

    30 days

  • 90 day mortality

    90 days

Interventions

Eligibility Criteria

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

The population consists of an absolute majority of the patients treated in Swedish intensive care units with the relevant diagnoses during the study period and can therefore be considered a nationwide population rather than a sample thereof.

You may qualify if:

  • Registered intensive care episode with relevant diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University, department of Surgical Sciences

Uppsala, 75185, Sweden

Location

MeSH Terms

Conditions

SepsisRespiratory Distress SyndromeCOVID-19Critical Illness

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsLung DiseasesRespiratory Tract DiseasesRespiration DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsDisease Attributes

Study Officials

  • Miklós Lipcsey, MD, PhD

    Upsala 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

May 23, 2022

First Posted

May 27, 2022

Study Start

August 26, 2021

Primary Completion

August 26, 2021

Study Completion

August 26, 2021

Last Updated

May 27, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Individual participant data are used with special permission from the national ethical bord of Sweden (Etikprövningsmyndigheten) and the involved register keepers and so cannot be shared without an extended permission.

Locations