SepsisNCT06368336
Health Related Quality of Life After Intensive Care for Sepsis, a National Cohort Study.
An observational study of Sepsis and Septic Shock, run by Uppsala University Hospital.
Trial summary
The study aims to map the health-related quality of life (HRQoL) after intensive care for Sepsis with the hypothesis that it will be lower than that in the general population. The investigators also want to identify factors that are associated with low HRQoL, to see if those are available for interventions from the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock, Sepsis, Severe
- How many people
- 210,484 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2008to 31 Dec 2022
- How long will I take part?
- 2 Years
- 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: Nationwide registry of patients admitted to ICU treatment in Sweden.
Who may be able to join
- Admitted to an ICU in Sweden that reports to the Swedish ICU register
- Admitted between January 1st 2008 until February 28th 2020
- Admitted for sepsis or septic shock and / or
- Received sepsis or septic shock diagnosis during ICU stay
Who cannot join
- Age under 18
About this study
The study aims to map the health-related quality of life (HRQoL) after intensive care for Sepsis with the hypothesis that it will be lower than that in the general population. The investigators also want to identify factors that are associated with low HRQoL, to see if those are available for interventions from the health care system and society to improve quality of life after treatment for sepsis in the intensive care unit (ICU).
Read the detailed description
Background Sepsis is a common condition in intensive care units leading to severe illness with a high mortality. It can also lead to significant disability for the individuals after recovery.
Objective The investigators aim to study how intensive care for/with sepsis impacts the HRQoL and, if possible, identify improvable factors in the treatment and rehabilitation.
Method This is a cohort study on all ICU patients with sepsis registered in the Swedish Intensive Care registry (SIR) as well as age and gender matched population controls. The primary outcome variable HRQoL will be assessed by RAND-36. The investigators assess functional recovery by sick leave free days. SIR provides post-ICU follow-up data on RAND-36. The investigators will merge these data with data on comorbidity from the National patient register, causes of death from the National death registry, socioeconomic factors from Statistics Sweden, as well as the data on social benefits from the Swedish Social Insurance Agency.
The main analysis compares RAND-36 from sepsis patients with population controls over time. The investigators will also compare the complete sepsis cohort's burden of inability to work before and sick leave free days after sepsis with matched population controls. Additionally, the investigators will describe the complete sepsis cohort's burden of disease measured with Charlson Comorbidity Index against matched population controls.
Ethics The study has ethical permission from Swedish Ethical Review Authority, nos 2022-00445-01 and 2022-07264-02.
Eligibility All patients over 18 with sepsis or septic shock diagnosis admitted to ICU between January 1st 2008 until February 28th 2020 .
Study Population Nationwide registry of patients admitted to ICU treatment in Sweden. Intervention/Treatment No active intervention, but the study subjects have had Intensive Care for sepsis or septic shock.
Official title Health Related Quality of Life after intensive care for Sepsis, a National Cohort study.
- Conditions
- Sepsis, Septic Shock, Sepsis, Severe
- Keywords
- RAND-36, ICU-treatment, Health-related Quality of Life, HRQoL, ICU-outcome, SF-36
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sepsis case | Nationwide registry of patients admitted to ICU treatment for or with sepsis, in Sweden, older than18 years of age. | |
| Control | Age and gender matched population controls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related Quality of Life after ICU (intensive care unit) treatment with/for sepsis
Health-related Quality of Life (HRQoL), measured with the RAND-36 test over time after ICU treatment with/for sepsis compared with population controls. The RAND-36 is a test that assess Health-Related Quality of Life were higher scores are associated with higher HRQoL.
Measured: Data dependent but up untill about 15 moth anticipated
Secondary outcomes (2)
Ability to work before and after ICU (intensive care unit) treatment for Sepsis
The investigators will also compare the complete sepsis cohort's sick leave free days after sepsis with matched population controls. This by the Swedish Social Insurance Agency register on days with economic compensation for sick leave.
Measured: 1 year prior ICU admittance and 2 years after ICU admittance
The burden of disease at ICU (intensive care unit) admittance and after ICU treatment for Sepsis
The investigators will describe the burden of disease with Charlson Comorbidity Index according to registered diagnoses with matched population controls at ICU admittance and after ICU treatment for Sepsis. The Charlson comorbidity index is primarily used for predicted mortality rate based on comorbidity and age were higher scores predicts higher predicted mortality rate.
Measured: From ICU admittance and 2 years after ICU admittance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start1 Jan 2008
- Primary completion1 Apr 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- 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
- 210,484 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sepsisfonden
- Responsible party
- Principal investigator, Miklos Lipcsey, Uppsala University Hospital
- Investigators
- Miklós Lipcsey, MD, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368336
- Sponsor's protocol ID
- 994894
- Status last verified
- Apr 2024
- First submitted
- 25 Mar 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study are available from the respective national registries in Sweden with restrictions as defined by the General Data Protection Regulation (GDPR), the Swedish Personal Data Act (1998:204), and the licenses with the respective national registries, and so are not publicly available. Data are however available from the respective national registries after reasonable request and adequate permissions from the Swedish ethical review authority under the restrictions outlined above.
Publications
Halvorsen P, Marks-Hultstrom M, Wallin E, Ahlstrom B, Lipcsey M. Health-related quality of life and functional recovery after intensive care for sepsis in a national cohort. Intensive Care Med. 2025 Jul;51(7):1282-1291. doi: 10.1007/s00134-025-07998-8. Epub 2025 Jun 23.
PubMed 40549021
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Related Quality of Life After Intensive Care for Sepsis, a National Cohort Study.
- ClinicalTrials.gov ID
- NCT06368336
- Acronym / sponsor ID
- 994894
- Conditions
- Sepsis, Septic Shock, Sepsis, Severe
- Keywords
- RAND-36, ICU-treatment, Health-related Quality of Life, HRQoL, ICU-outcome, SF-36
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210,484 participants (actual)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Collaborators
- Sepsisfonden
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 16 Apr 2024 (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 study aims to map the health-related quality of life (HRQoL) after intensive care for Sepsis with the hypothesis that it will be lower than that in the general population. The investigators also want to identify factors that are associated with low HRQoL, to see if those are available for interventions from the health care system and society to improve quality of life after treatment for sepsis in the intensive care unit (ICU).
Detailed description
Background Sepsis is a common condition in intensive care units leading to severe illness with a high mortality. It can also lead to significant disability for the individuals after recovery.
Objective The investigators aim to study how intensive care for/with sepsis impacts the HRQoL and, if possible, identify improvable factors in the treatment and rehabilitation.
Method This is a cohort study on all ICU patients with sepsis registered in the Swedish Intensive Care registry (SIR) as well as age and gender matched population controls. The primary outcome variable HRQoL will be assessed by RAND-36. The investigators assess functional recovery by sick leave free days. SIR provides post-ICU follow-up data on RAND-36. The investigators will merge these data with data on comorbidity from the National patient register, causes of death from the National death registry, socioeconomic factors from Statistics Sweden, as well as the data on social benefits from the Swedish Social Insurance Agency.
The main analysis compares RAND-36 from sepsis patients with population controls over time. The investigators will also compare the complete sepsis cohort's burden of inability to work before and sick leave free days after sepsis with matched population controls. Additionally, the investigators will describe the complete sepsis cohort's burden of disease measured with Charlson Comorbidity Index against matched population controls.
Ethics The study has ethical permission from Swedish Ethical Review Authority, nos 2022-00445-01 and 2022-07264-02.
Eligibility All patients over 18 with sepsis or septic shock diagnosis admitted to ICU between January 1st 2008 until February 28th 2020 .
Study Population Nationwide registry of patients admitted to ICU treatment in Sweden. Intervention/Treatment No active intervention, but the study subjects have had Intensive Care for sepsis or septic shock.
Official title Health Related Quality of Life after intensive care for Sepsis, a National Cohort study.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis case | – | –Nationwide registry of patients admitted to ICU treatment for or with sepsis, in Sweden, older than18 years of age. |
| Control | – | –Age and gender matched population controls. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Nationwide registry of patients admitted to ICU treatment in Sweden.
Key inclusion criteria (4 listed)
- Admitted to an ICU in Sweden that reports to the Swedish ICU register
- Admitted between January 1st 2008 until February 28th 2020
- Admitted for sepsis or septic shock and / or
- Received sepsis or septic shock diagnosis during ICU stay
Key exclusion criteria (1 listed)
- Age under 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health-related Quality of Life after ICU (intensive care unit) treatment with/for sepsis
Time frame: Data dependent but up untill about 15 moth anticipated
Health-related Quality of Life (HRQoL), measured with the RAND-36 test over time after ICU treatment with/for sepsis compared with population controls. The RAND-36 is a test that assess Health-Related Quality of Life were higher scores are associated with higher HRQoL.
2 secondary outcomes
Ability to work before and after ICU (intensive care unit) treatment for Sepsis
Time frame: 1 year prior ICU admittance and 2 years after ICU admittance
The burden of disease at ICU (intensive care unit) admittance and after ICU treatment for Sepsis
Time frame: From ICU admittance and 2 years after ICU admittance
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 17 Apr 2024.
- Derived from this study: PubMed 40549021Halvorsen P, Marks-Hultstrom M, Wallin E, Ahlstrom B, Lipcsey M. Health-related quality of life and functional recovery after intensive care for sepsis in a national cohort. Intensive Care Med. 2025 Jul;51(7):1282-1291. doi: 10.1007/s00134-025-07998-8. Epub 2025 Jun 23.
- Individual participant dataSharing planned: No. The data that support the findings of this study are available from the respective national registries in Sweden with restrictions as defined by the General Data Protection Regulation (GDPR), the Swedish Personal Data Act (1998:204), and the licenses with the respective national registries, and so are not publicly available. Data are however available from the respective national registries after reasonable request and adequate permissions from the Swedish ethical review authority under the restrictions outlined above.
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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.
Miklós Lipcsey, MD, PhD principal investigator
Uppsala University
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic Shock, run by Uppsala University Hospital.
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 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 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Health-related Quality of Life after ICU (intensive care unit) treatment with/for sepsis (time frame: Data dependent but up untill about 15 moth anticipated). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06368336, which also lists 1 linked publication.
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 17 Apr 2024.