Clinical trial NCT06368336: Health Related Quality of Life After Intensive Care for Sepsis, a National Cohort Study.
Official title: Health Related Quality of Life After Intensive Care for Sepsis, a National Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Septic Shock
Sepsis, Severe
Keywords: RAND-36
ICU-treatment
Health-related Quality of Life
HRQoL
ICU-outcome
SF-36
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
Collaborators: name: Sepsisfonden
First posted: 2024-04-16
Enrollment: 210484
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nationwide registry of patients admitted to ICU treatment in Sweden.

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Health-related Quality of Life after ICU (intensive care unit) treatment with/for sepsis
timeFrame: Data dependent but up untill about 15 moth anticipated
Secondary outcomes:
measure: Ability to work before and after ICU (intensive care unit) treatment for Sepsis
timeFrame: 1 year prior ICU admittance and 2 years after ICU admittance
measure: The burden of disease at ICU (intensive care unit) admittance and after ICU treatment for Sepsis
timeFrame: From ICU admittance and 2 years after ICU admittance
Other outcomes:
Locations:
Study officials:
affiliation: Uppsala University
name: Miklós Lipcsey, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: