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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06368336
• Other study ID #: 994894
• Status: Completed
• Start date: January 1, 2008
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2024
• Source: Uppsala University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 health care system and society to improve quality of life after treatment for sepsis in the intensive care unit (ICU).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210484
• Est. completion date: December 31, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Sepsis, Severe
• Septic Shock
• Toxemia

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University Hospital	Sepsisfonden

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Data dependent but up untill about 15 moth anticipated
Secondary	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.	1 year prior ICU admittance and 2 years after ICU admittance
Secondary	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.	From ICU admittance and 2 years after ICU admittance