Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000533291
Ethics application status
Approved
Date submitted
14/12/2017
Date registered
10/04/2018
Date last updated
7/07/2020
Date data sharing statement initially provided
26/04/2019
Date results information initially provided
26/04/2019
Type of registration
Prospectively registered

Titles & IDs
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
Secondary ID [1] 293588 0
None
Universal Trial Number (UTN)
U1111-1205-4606
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia ICD10: F00.x–F03.x, F05.1, G30.x, G31.1 305832 0
Severe sepsis ICD10: R65.1 305833 0
Septic shock ICD10: R57.2 305834 0
Sepsis ICD10: A41.9 306690 0
Condition category
Condition code
Neurological 305046 305046 0 0
Dementias
Neurological 305047 305047 0 0
Alzheimer's disease
Infection 305048 305048 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
5.5
Target follow-up type
Years
Description of intervention(s) / exposure
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.
Intervention code [1] 299841 0
Diagnosis / Prognosis
Comparator / control treatment
Patients treated in ICU without sepsis in the Swedish ICU-registry (SIR) between the years 2005 and 2016. Patients will be followed until December 31st 2016
Control group
Active

Outcomes
Primary outcome [1] 304207 0
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.
Timepoint [1] 304207 0
From enrolment, participants were assessed daily until death, diagnosis of dementia or censoring at December 31st, 2016.
Secondary outcome [1] 341256 0
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.
Timepoint [1] 341256 0
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).

Eligibility
Key inclusion criteria
First episode, per patient, of ICU-care with a diagnosis of sepsis in the SIR.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
This is a register study. The SIR includes all but five ICUs in Sweden, hence the sample is all but a few ICU-episodes during the years of 2005 through 2016 in Sweden. Any inpatient diagnoses between January 1:st 2000 and December 31:st 2016 will be retrieved from the Patient registry database of the Swedish national board of helath.

Crude incidence of new dementia diagnosis in ICU-treated patients with sepsis will be explored by survival analysis (Cumulative incidince competing risk, CICR) and the difference to all ICU-treated patients without sepsis will be assessed. An adjusted analysis by a Cox (stratified cause specific hazards) model will also be employed.
Risk factors for dementia before and during ICU care will be assessed by Cox regression (cause specific relative hazard).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/04/2018
Actual
11/04/2018
Date of last participant enrolment
Anticipated
Actual
11/04/2018
Date of last data collection
Anticipated
Actual
11/12/2018
Sample size
Target
200000
Accrual to date
Final
210378
Recruitment outside Australia
Country [1] 9426 0
Sweden
State/province [1] 9426 0
Whole country

Funding & Sponsors
Funding source category [1] 298205 0
University
Name [1] 298205 0
Uppsala university, the institution of surgical sciences
Country [1] 298205 0
Sweden
Funding source category [2] 298206 0
Hospital
Name [2] 298206 0
Landstinget Dalarna, the Center of Clinical Research, CKF
Country [2] 298206 0
Sweden
Primary sponsor type
University
Name
Uppsala university, the institution of surgical sciences
Address
Head of department Per Hellman
Akademiska sjukhuset ing 70 1 tr
S751 85 UPPSALA
Sweden
Country
Sweden
Secondary sponsor category [1] 297305 0
None
Name [1] 297305 0
None
Address [1] 297305 0
None
Country [1] 297305 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299213 0
Regional Ethical Review Board in Uppsala
Ethics committee address [1] 299213 0
Regionala etikprövningsnämnden i Uppsala
Box 1964
751 49 UPPSALA
Ethics committee country [1] 299213 0
Sweden
Date submitted for ethics approval [1] 299213 0
27/09/2016
Approval date [1] 299213 0
12/10/2016
Ethics approval number [1] 299213 0
2016/421

Summary
Brief summary
Intensive care unit treated sepsis, severe sepsis and septic shock are associated with several long term complications from different organs systems. There is evidence of accelerated impairment of cognitive functions when repeated cognitive testing is performed before and after a sepsis period. However it is not known if the cognitive impairment eventually is reflected in an increased frequency of dementia in an age-mixed ICU population. For this reason we wish to explore the incidence of dementia and identify its risk factors in sepsis survivors.

This will be done in the Swedish intensive care cohort defined as all patients with an ICU episode with severe sepsis or septic shock in the Swedish intensive care registry from 2005 to 2016. Diagnosis of dementia will be identified in the Swedish National board of health Patient registry. Patients without a diagnosis of dementia before ICU will be followed from first sepsis to 2016 for a new dementia diagnosis and compared to all ICU/treated patients without severe sepsis or septic shock.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79678 0
Dr Bjoern Ahlstroem
Address 79678 0
Björn Ahlström
Falu lasarett
Op/an/iva-kliniken
S791 82 Falun
Sweden
Country 79678 0
Sweden
Phone 79678 0
+46 23 492258
Fax 79678 0
Email 79678 0
[email protected]
Contact person for public queries
Name 79679 0
Dr Bjoern Ahlstroem
Address 79679 0
Björn Ahlström
Falu lasarett
Op/an/iva-kliniken
S791 82 Falun
Sweden
Country 79679 0
Sweden
Phone 79679 0
+46 23 492258
Fax 79679 0
Email 79679 0
[email protected]
Contact person for scientific queries
Name 79680 0
Dr Bjoern Ahlstroem
Address 79680 0
Björn Ahlström
Falu lasarett
Op/an/iva-kliniken
S791 82 Falun
Sweden
Country 79680 0
Sweden
Phone 79680 0
+46 23 492258
Fax 79680 0
Email 79680 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Sharing individual participant data is not i complience with the ethical approval.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4688Study results articleYes Ahlström B, Larsson IM, Strandberg G, Lipcsey M. A... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA nationwide study of the long-term prevalence of dementia and its risk factors in the Swedish intensive care cohort.2020https://dx.doi.org/10.1186/s13054-020-03203-y
N.B. These documents automatically identified may not have been verified by the study sponsor.