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Clinical Trials/NCT04228380
NCT04228380CompletedNot Applicable

Limitations and Mortality in Intensive Care

Göteborg University1 site in 1 country400 target enrollmentStarted: March 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
400
Locations
1
Primary Endpoint
Variables that independently impact decisions to limit LST ICU's. Differences between covid-19 and non-Covid-19 patients.

Study Overview

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.

Detailed Description

Previous publications have demonstrated variability in end-of-life decision-making (ELDM) for critically ill patients (1-3).

Factors commonly described as underlying the variability in ELDM in northern Europe are patient-related factors such as age, sex, the severity of illness, frailty, chronic poor health, and diagnosis (4-6). Variability in ELDM is also caused by other less readily identifiable factors, such as preferences and experiences of the attending physicians (7-8).

When the pandemic of the coronavirus disease 2019 (COVID-19) struck worldwide, intensive care units (ICUs) were put under immense pressure, and resources were strained to their limit. More than 550 million cases and 6.3 million deaths have been reported worldwide (9). In Sweden, more than 9000 patients with COVID-19 were admitted for intensive care, dramatically increasing the demand for intensive care resources (10).

At the beginning of the pandemic, this disease was primarily unknown to physicians in the ICU, and its course and plausible patient outcomes were difficult to predict. Factors that have been demonstrated to predict poor long-term outcomes in critically ill COVID-19 patients are extensively studied. In a Swedish setting, they were found to be male sex, high age, high simplified acute physiology score (SAPS 3) (11), the month of admission, and preexisting conditions such as obesity, asthma, chronic obstructive pulmonary disease, malignancy, and immune deficiency (12).

End-of-life decisions in critically ill patients with and without COVID-19 are closely associated with short-term mortality (13-14). There are surprisingly few studies on EDLM in COVID-19 patients and whether these decisions were handled differently compared to other critically ill patients during the pandemic (15-16). It could be postulated that the process of ELDM changed during the pandemic as increased demands for intensive care caused an explicit lack of resources (17).

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
65 Years to 110 Years (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Declined consent to participate.

Outcomes

Primary Outcomes

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

Time Frame: 2020-2025

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.

Secondary Outcomes

  • Secondary outcomes(2020-2025)

Investigators

Sponsor
Göteborg University
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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