Health Related Quality of Life After Intensive Care for Sepsis, a National Cohort 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).

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis, Severe Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Age under 18

Treatment and study plan

Primary outcomes

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.

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 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.
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

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.

Sponsors and collaborators

Lead sponsor

Uppsala University Hospital

Other

Collaborators

Sepsisfonden

Registry information

Important dates

Study start: 2008
Primary completion: 2022
Study completion: 2022
First posted: Apr 16, 2024
Registry last updated: Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed