NCT04228380

Brief Summary

This is an observational prospective pilot-study that investigates which patient-related variables that predict a decision to limit life sustaining treatments. Some of the variables we were interested in cannot be accessed in registry data, such as frailty scale score and living at home or not. Furthermore we wanted to investigate if the variables that were independently associated with a decision to limit LST were different for critically ill patients with COVID-19 than for critically ill patients with other diagnoses in a Swedish intensive care unit during the pandemic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

October 2, 2023

Status Verified

September 1, 2023

Enrollment Period

3.5 years

First QC Date

January 10, 2020

Last Update Submit

September 29, 2023

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (1)

  • Variables that independently impact decisions to limit LST ICU's. Differences between covid-19 and non-Covid-19 patients.

    Impact of gender, age, frailty, comorbidities, invasive ventilation, SAPS 3, BMI, length of stay on decisions to limit LST in critical illness in Swedish ICU's.

    2020-2025

Secondary Outcomes (1)

  • Secondary outcomes

    2020-2025

Study Arms (2)

Inclusion

Inclusion criteria: The cohort is made up of adult patients over 65 years of age, admitted to an intensive care unit in Sweden, for other reason than postoperative care or simple monitoring.

Other: No intervention

Exclusion

Exclusion criteria: Declined consent to participate.

Other: No intervention

Interventions

No interventionOTHER

No intervention

ExclusionInclusion

Eligibility Criteria

Age65 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

I cohort with critically ill COVID-19 patients, 1 cohort with critically ill patients with other diagnosis than COVID-19.

You may qualify if:

  • Patients over 65 years admitted to an intensive care unit for care other than simple monitoring or uncomplicated postoperative care.

You may not qualify if:

  • Declined consent to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Linda Block, PhD

    Shalgrenska Academy, Gothenburg University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 10, 2020

First Posted

January 14, 2020

Study Start

March 1, 2020

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

October 2, 2023

Record last verified: 2023-09

Locations

SE(1)