SepsisNCT04542538
The Impact of Premorbid Illnesses on the Risk of ICU Admission and Short-term Outcome
An observational study of Sepsis and Corona Virus Infection, run by Uppsala University at 1 site in Sweden.
Trial summary
The Corona virus disease 2019 (COVID-19) pandemic is currently involving all parts of the world. Several risk factors for critical illness and death from the disease have been proposed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Corona Virus Infection, ARDS, Human
- How many people
- 9,905 participants
- Where
- 1 siteSweden
- Study dates
- 11 Apr 2018to 11 Jan 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The SIR is a registry to which all Swedish intensive care units are reporting all intensive care patients. The SIR has a specific part to wich all COVID-19 related intensive care eposodes are reported. All patients, approximally 2000, who have at least one COVID-19 listing in the SIRI will be included, as cases. Two historical control populations are extracted from the SIR between 2011 and 2016. One population with all patients having had severe sepsis and one with all patients having had ARDS during ICU care. We already have recieved all data on the studypopulation and the Control populations but will not set up the database or perform any analyses until this registration is be public.
Who may be able to join
- ° Individual registered in the Swedish intensive care registry (SIR) with COVID-19 Before 27 May 2020.
- or
- Individual registered in the SIR with Severe sepsis or septic chock 2011-2016. or
- Individual registered in the SIR with ARDS 2011-2016.
Who cannot join
- Age below 18 years
- Individual registered in the Swedish intensive care registry without a personal identification number
Trial locations and contacts
1 site in 1 country.
About this study
The Corona virus disease 2019 (COVID-19) pandemic is currently involving all parts of the world. Several risk factors for critical illness and death from the disease have been proposed. However, it is still unclear if the observed associations between different comorbidities and chronic medications and severe COVID-19 disease and mortality is different from associations between the same factors and other severe diseases requiring intensive care unit (ICU) -care. This is important since some of the observed risk factors are very common in the aged who, by age alone, are more prone to a more severe course of any disease. By combining several registries, this study will compare, on several comorbidities such as hypertension and diabetes , the first 2000 cases of COVID-19 patients receiving critical care in Sweden to a Swedish sepsis-cohort and a Swedish adult respiratory distress syndrome (ARDS) -cohort.
Read the detailed description
The Corona virus disease 2019 (COVID-19) pandemic is currently involving all parts of the world. Several risk factors for critical illness and death from the disease have been proposed. However, it is still unclear if the observed associations between different comorbidities and chronic medications and severe COVID-19 disease and mortality is different from associations between the same factors and other severe diseases requiring ICU-care. This is important since some of the observed risk factors are very common in the aged who, by age alone, are more prone to a more severe course of any disease. By combining several registries, this study will compare, on several comorbidities such as hypertension and diabetes , the first 2000 cases of COVID-19 patients receiving critical care in Sweden to a Swedish sepsis-cohort and a Swedish ARDS-cohort.
- Conditions
- Sepsis, Corona Virus Infection, ARDS, Human
- Being tested
- No intervention, observational study
- Medical subject headings
- Sepsis, Coronavirus Infections, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, observational studyOther
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 critical care patients | All patients who have received intensive care with COVID-19 in Sweden until May 27, 2020. Patients are identified in the Swedish Intensive care registry, to which all Swedish intensive care units (ICU) are reporting all intensive care patients. Receives: Other: No intervention, observational study | |
| Sepsis critical care patients | All patients who have received intensive care with severe sepsis or septic shock in Sweden between 2011 and 2016. Patients are identified in the Swedish Intensive care registry, to which all Swedish intensive care units (ICU) are reporting all intensive care patients. Receives: Other: No intervention, observational study | |
| ARDS critical care patients | All patients who have received intensive care with ARDS in Sweden between 2011 and 2016. Patients are identified in the Swedish Intensive care registry, to which all Swedish intensive care units (ICU) are reporting all intensive care patients. Receives: Other: No intervention, observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk factors of ICU care COVID-19/Sepsis
In a binary logistics model with the outcome Sepsis or COVID-19 the OR for several comorbidities are determined.
Measured: Five years preceding ICU admission to ICU admission
Risk factors of ICU care COVID-19/ARDS
In a binary logistics model with the outcome ARDS or COVID-19 the OR for several comorbidities are determined.
Measured: Five years preceding ICU admission to ICU admission
Risk factors of ICU mortality COVID-19/Sepsis
In a Cox proportional hazards model with the outcome ICU-mortality the hazard ratio (HR) for the interaction between several comorbidities and a binary variable COVID-19/Sepsis are determined.
Measured: Five years preceding ICU admission to ICU discharge
Risk factors of ICU mortality COVID-19/ARDS
In a Cox proportional hazards model with the outcome ICU-mortality the HR for the interaction between several comorbidities and a binary variable COVID-19/ARDS are determined.
Measured: Five years preceding ICU admission to ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start11 Apr 2018
- Primary completion4 Jun 2020
- Study completion11 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Uppsala 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
- Other
- Enrolment
- 9,905 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Clinical Research Dalarna, Sweden
- Responsible party
- Sponsor
- Investigators
- Miklos Lipcsey, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542538
- Sponsor's protocol ID
- U1111-1257-2830
- Status last verified
- Apr 2021
- First submitted
- 21 Aug 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Premorbid Illnesses on the Risk of ICU Admission and Short-term Outcome
- ClinicalTrials.gov ID
- NCT04542538
- Acronym / sponsor ID
- U1111-1257-2830
- Conditions
- Sepsis, Corona Virus Infection, ARDS, Human
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,905 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Center for Clinical Research Dalarna, Sweden
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 4 Jun 2020 (actual)
- Study completion
- 11 Jan 2021 (actual)
- First posted
- 9 Sep 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.
The Corona virus disease 2019 (COVID-19) pandemic is currently involving all parts of the world. Several risk factors for critical illness and death from the disease have been proposed. However, it is still unclear if the observed associations between different comorbidities and chronic medications and severe COVID-19 disease and mortality is different from associations between the same factors and other severe diseases requiring intensive care unit (ICU) -care. This is important since some of the observed risk factors are very common in the aged who, by age alone, are more prone to a more severe course of any disease. By combining several registries, this study will compare, on several comorbidities such as hypertension and diabetes , the first 2000 cases of COVID-19 patients receiving critical care in Sweden to a Swedish sepsis-cohort and a Swedish adult respiratory distress syndrome (ARDS) -cohort.
Detailed description
The Corona virus disease 2019 (COVID-19) pandemic is currently involving all parts of the world. Several risk factors for critical illness and death from the disease have been proposed. However, it is still unclear if the observed associations between different comorbidities and chronic medications and severe COVID-19 disease and mortality is different from associations between the same factors and other severe diseases requiring ICU-care. This is important since some of the observed risk factors are very common in the aged who, by age alone, are more prone to a more severe course of any disease. By combining several registries, this study will compare, on several comorbidities such as hypertension and diabetes , the first 2000 cases of COVID-19 patients receiving critical care in Sweden to a Swedish sepsis-cohort and a Swedish ARDS-cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COVID-19 critical care patients | – | Other: No intervention, observational studyAll patients who have received intensive care with COVID-19 in Sweden until May 27, 2020. Patients are identified in the Swedish Intensive care registry, to which all Swedish intensive care units (ICU) are reporting all intensive care patients. |
| Sepsis critical care patients | – | Other: No intervention, observational studyAll patients who have received intensive care with severe sepsis or septic shock in Sweden between 2011 and 2016. Patients are identified in the Swedish Intensive care registry, to which all Swedish intensive care units (ICU) are reporting all intensive care patients. |
| ARDS critical care patients | – | Other: No intervention, observational studyAll patients who have received intensive care with ARDS in Sweden between 2011 and 2016. Patients are identified in the Swedish Intensive care registry, to which all Swedish intensive care units (ICU) are reporting all intensive care patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The SIR is a registry to which all Swedish intensive care units are reporting all intensive care patients. The SIR has a specific part to wich all COVID-19 related intensive care eposodes are reported. All patients, approximally 2000, who have at least one COVID-19 listing in the SIRI will be included, as cases. Two historical control populations are extracted from the SIR between 2011 and 2016. One population with all patients having had severe sepsis and one with all patients having had ARDS during ICU care. We already have recieved all data on the studypopulation and the Control populations but will not set up the database or perform any analyses until this registration is be public.
Key inclusion criteria (4 listed)
- ° Individual registered in the Swedish intensive care registry (SIR) with COVID-19 Before 27 May 2020.
- or
- Individual registered in the SIR with Severe sepsis or septic chock 2011-2016. or
- Individual registered in the SIR with ARDS 2011-2016.
Key exclusion criteria (2 listed)
- Age below 18 years
- Individual registered in the Swedish intensive care registry without a personal identification number
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 intervention, observational study | Other | ARDS critical care patients, COVID-19 critical care patients, Sepsis critical care patients |
Primary outcome
Risk factors of ICU care COVID-19/Sepsis
Time frame: Five years preceding ICU admission to ICU admission
In a binary logistics model with the outcome Sepsis or COVID-19 the OR for several comorbidities are determined.
Risk factors of ICU care COVID-19/ARDS
Time frame: Five years preceding ICU admission to ICU admission
In a binary logistics model with the outcome ARDS or COVID-19 the OR for several comorbidities are determined.
Risk factors of ICU mortality COVID-19/Sepsis
Time frame: Five years preceding ICU admission to ICU discharge
In a Cox proportional hazards model with the outcome ICU-mortality the hazard ratio (HR) for the interaction between several comorbidities and a binary variable COVID-19/Sepsis are determined.
Risk factors of ICU mortality COVID-19/ARDS
Time frame: Five years preceding ICU admission to ICU discharge
In a Cox proportional hazards model with the outcome ICU-mortality the HR for the interaction between several comorbidities and a binary variable COVID-19/ARDS are determined.
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 28 Apr 2021.
- Individual participant dataSharing planned: No
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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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.
Miklos Lipcsey, PhD principal investigator
Uppsala 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 Sepsis and Corona Virus Infection, run by Uppsala 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 4 inclusion and 2 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 28 Apr 2021. 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?
Risk factors of ICU care COVID-19/Sepsis (time frame: Five years preceding ICU admission to ICU admission). The study lists 4 primary outcomes in all. 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 28 Apr 2021.