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

NCT06368336 | Completed

• 1 other identifier: 994894
• Study Type: observational
• Target: 210,484
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Sepsis; Septic Shock; Sepsis, Severe

Keywords

RAND-36; ICU-treatment; Health-related Quality of Life; HRQoL; ICU-outcome; SF-36

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Ability to work before and after ICU (intensive care unit) treatment for Sepsis

  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

  From ICU admittance and 2 years after ICU admittance

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Nationwide registry of patients admitted to ICU treatment in Sweden.

You may qualify if:

• 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

You may not qualify if:

• Age under 18

Sponsors & Collaborators

• Uppsala University Hospital: lead
• Sepsisfonden: collaborator

Related Publications (1)

• 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.

  PMID: 40549021 DERIVED

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Miklós Lipcsey, MD, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 16, 2024
• Study Start: January 1, 2008
• Primary Completion: April 1, 2022
• Study Completion: December 31, 2022
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share