Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001281189
Ethics application status
Approved
Date submitted
5/06/2019
Date registered
17/09/2019
Date last updated
17/12/2020
Date data sharing statement initially provided
17/09/2019
Date results information initially provided
17/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The causes and pattern of short and long term mortality stratified on sepsis in the Swedish ICU-cohort
Scientific title
The causes and pattern of short and long term mortality stratified on sepsis in the Swedish ICU-cohort
Secondary ID [1] 298403 0
Nil known
Universal Trial Number (UTN)
U1111-1234-6173
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sepsis (ICD10) A41.9 313108 0
Severe sepsis R65.1 313109 0
Septic shock R57.2 313110 0
Condition category
Condition code
Infection 311589 311589 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observational registry study. Virtually all patients recieving care in an Intensive Care Unit (ICU) in Sweden are reported to the Swedish ICU-registry (SIR) with base-line data, performed interventions and ICU relevant diagnoses, but this does not affect their care in any way.
The exposure is ICU care with sepsis, severe sepsis or septic shock in the SIR during the years 2005 to 2016. All patients are followed from inclusion to 31st of december 2016 or Death, wichever comes first.
This means: No participant involvement. The paticipant is observed from ICU-admission until 31-dec-2016, death or recieving a diagosis of Dementia.
Intervention code [1] 314649 0
Early Detection / Screening
Comparator / control treatment
The control group i made up of all patients in the SIR not having a diagnosis of sepsis, severe sepsis or septic shock during their care in the ICU.
Control group
Active

Outcomes
Primary outcome [1] 320290 0
Time to Death from ICU-admission. Time of Death is assessed by audit of SIR data.
Timepoint [1] 320290 0
The primary ocutcome is assesed by review of SIR data when the registration-process with the ANZCTR is completed.
Secondary outcome [1] 374257 0
Cause of Death grouped according to the European short list. Cause of Death as assessed by audit of data from the National Death Registry of the Swedish board of Health and Welfare.
Timepoint [1] 374257 0
The secondary outcome is assesed by review of National Death Registry data when the registration-process with the ANZCTR is completed.

Eligibility
Key inclusion criteria
First episode, per patient, of ICU-care with a diagnosis of sepsis in the SIR.
First episode, per patient, of ICU-care if no care epsiode with 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.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
This is a register study. The SIR includes (during the current time period) almost all general ICUs in Sweden, hence the sample is all but a few ICU episodes during the years of 2005 through 2016.
Mortality rate in the time intervalls 0 - 10 days , 11 - 30 days , 31 - 90 days , 91 days - 6 months, 6 months - 1 year, 1 - 3 years, 3 - 5 years, 5 – 7 years, 7 - 12 years stratified on sepsis or not during ICU care. will be explored by Kaplan-Meier figures. For the same time intervalls Cox-regression models will be fitted to explore factors, including sepsis, correlating with the hazard ratio for Death.
Cases of Death will be explored bu Chi2 test over the time intervalls mentioned above stratified on sesps or not during ICU care. An adjusted analysis in Cox-model will also be performed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/09/2019
Actual
30/09/2019
Date of last participant enrolment
Anticipated
30/09/2019
Actual
30/09/2019
Date of last data collection
Anticipated
30/09/2019
Actual
30/09/2019
Sample size
Target
300000
Accrual to date
Final
315156
Recruitment outside Australia
Country [1] 21558 0
Sweden
State/province [1] 21558 0

Funding & Sponsors
Funding source category [1] 302943 0
University
Name [1] 302943 0
Uppsala university, the institution of surgical sciences
Country [1] 302943 0
Sweden
Funding source category [2] 302948 0
Hospital
Name [2] 302948 0
Region Dalarna, the Center of Clinical Research, CKF
Country [2] 302948 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
Country
Sweden
Secondary sponsor category [1] 303763 0
None
Name [1] 303763 0
Address [1] 303763 0
Country [1] 303763 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303505 0
Regionala etikprövningsnämnden i Uppsala
Ethics committee address [1] 303505 0
Regionala etikprövningsnämnden i Uppsala
Box 1964
751 49 UPPSALA
Ethics committee country [1] 303505 0
Sweden
Date submitted for ethics approval [1] 303505 0
27/09/2016
Approval date [1] 303505 0
12/10/2016
Ethics approval number [1] 303505 0
2016/421

Summary
Brief summary
The risk of death in patients treated for sepsis the Intensive care unit (ICU) is high. The increased risk of death is persistent over years, however little is known about their long term risk of death when compared to patients treated for other causes in the ICU. Also little is known about the pattern on the causes of Death in ICU treated patients with and without sepsis.
Our hypothesis is that the long term causes of Death are different for individuals treated for sepsis in the ICU compared to individuals treated for other reasons in the ICU. This will be investigated in the Swedish ICU cohort during the years 2005 to 2016.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93898 0
A/Prof Miklos Lipcsey
Address 93898 0
Institutionen för kirurgiska vetenskaper
Uppsala Universitet
Akademiska Sjukhuset
S-751 82 Uppsala
Country 93898 0
Sweden
Phone 93898 0
+46 018 611 0000
Fax 93898 0
Email 93898 0
[email protected]
Contact person for public queries
Name 93899 0
Dr Björn Ahlström
Address 93899 0
Falu lasarett
Op/an/iva-kliniken
S-791 82 Falun
Country 93899 0
Sweden
Phone 93899 0
+46 23 492258
Fax 93899 0
Email 93899 0
[email protected]
Contact person for scientific queries
Name 93900 0
Dr Björn Ahlström
Address 93900 0
Falu lasarett
Op/an/iva-kliniken
S-791 82 Falun
Country 93900 0
Sweden
Phone 93900 0
+46 23 492258
Fax 93900 0
Email 93900 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 in 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.