ANZCTR - Registration

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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 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]

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

Severe sepsis ICD10: R65.1

Septic shock ICD10: R57.2

Sepsis ICD10: A41.9

Condition category

Condition code

Neurological

Dementias

Neurological

Alzheimer's disease

Infection

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]

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]

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]

From enrolment, participants were assessed daily until death, diagnosis of dementia or censoring at December 31st, 2016.

Secondary outcome [1]

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]

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?

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]

Sweden

State/province [1]

Whole country

Funding & Sponsors

Funding source category [1]

University

Name [1]

Uppsala university, the institution of surgical sciences

Address [1]

Akademiska sjukhuset ing 70 1 tr
S751 85 UPPSALA
Sweden

Country [1]

Sweden

Funding source category [2]

Hospital

Name [2]

Landstinget Dalarna, the Center of Clinical Research, CKF

Address [2]

Nissers väg 3
S791 82 Falun
Sweden

Country [2]

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]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Regional Ethical Review Board in Uppsala

Ethics committee address [1]

Regionala etikprövningsnämnden i Uppsala
Box 1964
751 49 UPPSALA

Ethics committee country [1]

Sweden

Date submitted for ethics approval [1]

27/09/2016

Approval date [1]

12/10/2016

Ethics approval number [1]

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

Dr Bjoern Ahlstroem

Address

Björn Ahlström
Falu lasarett
Op/an/iva-kliniken
S791 82 Falun
Sweden

Country

Sweden

Phone

+46 23 492258

Fax

bjorn.ahlstrom@surgsci.uu.se

Contact person for public queries

Name

Bjoern Ahlstroem

Address

Björn Ahlström
Falu lasarett
Op/an/iva-kliniken
S791 82 Falun
Sweden

Country

Sweden

Phone

+46 23 492258

Fax

bjorn.ahlstrom@surgsci.uu.se

Contact person for scientific queries

Name

Bjoern Ahlstroem

Address

Björn Ahlström
Falu lasarett
Op/an/iva-kliniken
S791 82 Falun
Sweden

Country

Sweden

Phone

+46 23 492258

Fax

bjorn.ahlstrom@surgsci.uu.se

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Ahlström B, Larsson IM, Strandberg G, Lipcsey M. A... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A nationwide study of the long-term prevalence of dementia and its risk factors in the Swedish intensive care cohort.	2020	https://dx.doi.org/10.1186/s13054-020-03203-y

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically