Critical IllnessLIMONCT04228380
Limitations and Mortality in Intensive Care
An observational study of Critical Illness, run by Göteborg University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 110 years
- Conditions the study is for
- Critical Illness
- How many people
- 400 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2020to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 110 years
- All sexes
- No healthy volunteers
- Older adult
Study population: I cohort with critically ill COVID-19 patients, 1 cohort with critically ill patients with other diagnosis than COVID-19.
Who may be able to join
- Patients over 65 years admitted to an intensive care unit for care other than simple monitoring or uncomplicated postoperative care.
Who cannot join
- Declined consent to participate.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
We hypothesised that ELDM was challenging for COVID-19 patients due to several uncertainties concerning prognostication. Therefore, we stipulated that end-of-life decisions in COVID-19 patients were made for older patients with higher frailty scores than the non-COVID-19 cohort and that end-of-life decisions were postponed to later in the course of the COVID-19 disease. We also hypothesised that a more significant proportion of patients in the COVID-19 cohort died without any end-of-life decision being made before death compared to the non-COVID-19 cohort.
In this study, we primarily aimed to investigate which independent factors predicted a decision to withdraw or withhold life-sustaining treatments (LST) in critically ill patients if these decisions were based on different variables for critically ill patients with COVID-19 compared to critically ill patients with other diagnoses in a Swedish ICU. Secondly, we aimed to investigate if ELDM was made later in the course of the disease for COVID-19 patients and if a higher proportion of COVID-19 patients died without any decision to limit LST.
- Conditions
- Critical Illness
- Being tested
- No intervention
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention | |
| Exclusion | Exclusion criteria: Declined consent to participate. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2020-2025
Secondary outcomes (1)
Secondary outcomes
The secondary outcome was the time from admission to the end-of-life decision and to investigate if a higher proportion of patients in the COVID-19 cohort died without a previous decision to limit life sustaining treatments. Furthermore, we aimed to investigate if mortality differed between the groups. In addition, we aimed to investigate if survival after a decision to limit LST differed between the groups.
Measured: 2020-2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start1 Mar 2020
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda Block, PhD, Principal investigator, Shalgrenska Academy, Gothenburg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228380
- Sponsor's protocol ID
- LIMO
- Acronym
- LIMO
- Status last verified
- Sep 2023
- First submitted
- 10 Jan 2020
- Last updated
- 2 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Limitations and Mortality in Intensive Care
- ClinicalTrials.gov ID
- NCT04228380
- Acronym / sponsor ID
- LIMO / LIMO
- Conditions
- Critical Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 14 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
We hypothesised that ELDM was challenging for COVID-19 patients due to several uncertainties concerning prognostication. Therefore, we stipulated that end-of-life decisions in COVID-19 patients were made for older patients with higher frailty scores than the non-COVID-19 cohort and that end-of-life decisions were postponed to later in the course of the COVID-19 disease. We also hypothesised that a more significant proportion of patients in the COVID-19 cohort died without any end-of-life decision being made before death compared to the non-COVID-19 cohort.
In this study, we primarily aimed to investigate which independent factors predicted a decision to withdraw or withhold life-sustaining treatments (LST) in critically ill patients if these decisions were based on different variables for critically ill patients with COVID-19 compared to critically ill patients with other diagnoses in a Swedish ICU. Secondly, we aimed to investigate if ELDM was made later in the course of the disease for COVID-19 patients and if a higher proportion of COVID-19 patients died without any decision to limit LST.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inclusion | – | Other: No interventionInclusion 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. |
| Exclusion | – | Other: No interventionExclusion criteria: Declined consent to participate. |
Who may qualify
- Ages
- 65 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- I cohort with critically ill COVID-19 patients, 1 cohort with critically ill patients with other diagnosis than COVID-19.
Key inclusion criteria (1 listed)
- Patients over 65 years admitted to an intensive care unit for care other than simple monitoring or uncomplicated postoperative care.
Key exclusion criteria (1 listed)
- Declined consent to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Exclusion, Inclusion |
Primary outcome
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.
1 secondary outcome
Secondary outcomes
Time frame: 2020-2025
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Block, PhD principal investigator
Shalgrenska Academy, Gothenburg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variables that independently impact decisions to limit LST ICU's. Differences between covid-19 and non-Covid-19 patients. (time frame: 2020-2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023; AzTrials last refreshed its copy on 3 Nov 2026.