The risk of dementia after sepsis in the Swedish ICU cohort

• Register: ANZCTR
• Last refreshed on: 13 July 2020
• Main ID: ACTRN12618000533291
• Date of registration: 10/04/2018
• Prospective Registration: Yes
• Primary sponsor: Uppsala university, the institution of surgical sciences
• Public title: The risk of dementia after sepsis in the Swedish ICU cohort
• Scientific title: The risk of dementia after sepsis in the Swedish ICU cohort
• Date of first enrolment: 11/04/2018
• Target sample size: 200000
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12618000533291.aspx
• Study type: Observational
• Study design: Purpose: Natural history;Duration: Longitudinal;Selection: Defined population;Timing: Both;
• Phase: Not Applicable

Countries of recruitment

Sweden

Contacts

• Name: Dr Bjoern Ahlstroem

• Name: Dr Bjoern Ahlstroem

Key inclusion & exclusion criteria

Inclusion criteria: First episode, per patient, of ICU-care with a diagnosis of sepsis in the SIR.
Exclusion criteria: Age below 18 years of age.
Already included with an earlier episode of ICU-treated sepsis.
Loss to follow-up: emigration or protected identity.
Dementia prior to, or diagnosed during, ICU episode.

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Neurological - Dementias

Dementia ICD10: F00.x–F03.x, F05.1, G30.x, G31.1;Severe sepsis ICD10: R65.1;Septic shock ICD10: R57.2;Sepsis ICD10: A41.9;
Dementia ICD10: F00.x–F03.x, F05.1, G30.x, G31.1
Severe sepsis ICD10: R65.1
Septic shock ICD10: R57.2
Sepsis ICD10: A41.9

Infection - Other infectious diseases

Neurological - Alzheimer's disease

Intervention(s)

The exposure is Intensive Care Unit (ICU) care for sepsis, severe sepsis or septic shock (sepsis) in the Swedish ICU-registry (SIR) between the years 2005 and 2016. Patients will be followed until december 31:st 2016.

Primary Outcome(s)

The outcome, risk of dementia in survival analysis, will be assessed as per diagnosis in the nation wide Patient registry of the Swedish National board of Health and wellfare. In Sweden it is mandatory to report all hospital care episodes with accompanying diagnoses to the Patient registry. The diagnosis of dementia, used to calcualate the risk of dementia, is thus at the discretion of the caring physician.[From enrolment, participants were assessed daily until death, diagnosis of dementia or censoring at December 31st, 2016. ]

Secondary Outcome(s)

Risk factors, before and during ICU treated sepsis, for dementia in a survival analysis.

Risk factors studied are: age, sex, Charlson comorbidity index (CCI), Simplified Acute Physiology Score 3 (SAPS), sepsis severity (sepsis, severe sepsis, septic shock) acute/elective admittance, preceding surgery (acute/elective), type of surgery (according to SAPS3), use of non-invasive ventilation, use of invasive ventilation, use of renal replacement therapy, type of hospital (district hospital, county hospital, University hospital), days in ICU.

CCI is assessed by screening the Patient registry for relevant diagnoses 5 years prior to ICU admittance. The remaining risk factors are extracted from the Swedish ICU registry.[The data is collected daily from 5 years prior to enrolement (comorbidity), at enrolement (age, sex, SAPS3, acute/elective admittance, preceding surgery (acute/elective), type of surgery, type of hospital) and at discharge from ICU (sepsis severity, use of non-invasive ventilation, use of invasive ventilation, use of renal replacement therapy, days in ICU).]

Secondary ID(s)

None

Source(s) of Monetary Support

Uppsala university, the institution of surgical sciences

Landstinget Dalarna, the Center of Clinical Research, CKF

Ethics review

Status: Approved
Approval date: 12/10/2016
Contact:

Regional Ethical Review Board in Uppsala

Results

• Results available: Yes
• Date Posted: 26/04/2019
• Date Completed: 11/12/2018