Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06368336
Status:
COMPLETED
Last Update Posted:
2024-04-17
First Post:
2024-03-25
Brief Title:
Health Related Quality of Life After Intensive Care for Sepsis a National Cohort Study
Sponsor:
Uppsala University Hospital
Organization:
Uppsala University Hospital
Study Overview
Official Title:
Health Related Quality of Life After Intensive Care for Sepsis a National Cohort Study
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 forwith 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 cohorts 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 cohorts 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 InterventionTreatment 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
Objective The investigators aim to study how intensive care forwith 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 cohorts 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 cohorts 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 InterventionTreatment 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None