Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621001303831
Ethics application status
Approved
Date submitted
3/05/2021
Date registered
27/09/2021
Date last updated
27/09/2021
Date data sharing statement initially provided
27/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Long-term outcome of children treated in a Swedish PICU 2008-2016
– a comparison with the Swedish normal population
Scientific title
Long-term outcome of children treated in a Swedish PICU 2008-2016
– a comparison with the Swedish normal population
Secondary ID [1] 302463 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness 319293 0
Condition category
Condition code
Public Health 317263 317263 0 0
Other public health

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A cohort of n=6520 admissions treated in the PICU at Astrid Lindgren Children’s Hospital, Karolinska University Hospital between 2008-2016 will be studied, providing survival data for at least four but up to twelve years. The main objective is to evaluate PICU and long-term mortality for different age and risk stratification groups using prospectively collected data archived in a Patient Data Management System (PDMS) and a national population register.


Data on survival status after PICU discharge is obtained from the population register (Swedish Tax Agency), a separate national database. The duration of follow-up will be determined by the date when we collect data on survival (dead or alive) from the population register.
Archived data will be accessed retrospectively with no active involvement by participants required.
Intervention code [1] 318759 0
Diagnosis / Prognosis
Comparator / control treatment
We will compare the cohort with the background natural mortality in Sweden, by a comparison of vital data for all children living in Sweden of the same age.


Data archived in the Patient Data Management System (PDMS) was collected 2018-2019.
Survival status after PICU discharge obtained from the population register (Swedish Tax Agency), was collected 2020.
The control population consisted of all Swedish individuals of the same age and sex. Statistics Sweden (Statistiska centralbyrån, Statistikmyndigheten SCB; www.scb.se) provided the mortality data regarding the children in the control group. It was collected 2020.
Control group
Historical

Outcomes
Primary outcome [1] 325324 0

Risk adjusted mortality compared to the general Swedish population and assessed by accessing data archived in PDMS, a national population register, and Statistics Sweden.
Timepoint [1] 325324 0
Assessed retrospectively for at least 3,5 years up to 12 years post-PICU admission
Secondary outcome [1] 387495 0
Long-term mortality assessed by accessing data archived in PDMS and national population register, and Statistics Sweden.
Timepoint [1] 387495 0
Assessed retrospectively for at least 3,5 years up to 12 years post-PICU admission

Eligibility
Key inclusion criteria
Consecutive admissions between 2008-2016 of critically ill children to the PICU of a tertiary university hospital.
Inclusion criteria for the control group was Swedish citizenship.
Minimum age
No limit
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Missing information on Predicted Death Rate (PDR) at admission.
Missing Swedish Social Security Number
Protected Identity

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Case control
Timing
Retrospective
Statistical methods / analysis
Data will be presented as median and inter-quartile range.
Mann-Whitney U-test will be used for the comparison of data from two independent populations. Several independent populations will be compared with the Kruskal-Wallis test Kaplan-Meyer analysis will be used for survival data.
Correlations will be established by the Spearman rank correlation test.
All statistical tests will be two-sided and p-values less than 0.05 will be considered to be statistical significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/10/2020
Date of last participant enrolment
Anticipated
Actual
20/11/2020
Date of last data collection
Anticipated
Actual
29/07/2021
Sample size
Target
7000
Accrual to date
Final
6520
Recruitment outside Australia
Country [1] 23042 0
Sweden
State/province [1] 23042 0

Funding & Sponsors
Funding source category [1] 306891 0
Government body
Name [1] 306891 0
Stockholms Läns Landsting. The County Council of Stockholm
Country [1] 306891 0
Sweden
Primary sponsor type
Hospital
Name
Karolinska University Hospital
Address
Pediatric Perioperative medicine and intensive care
Astrid Lindgren Children's Hospital
Karolinska University Hospital, Solna Stockholm
S-171 76 Stockholm
Sweden
Country
Sweden
Secondary sponsor category [1] 307448 0
None
Name [1] 307448 0
Address [1] 307448 0
Country [1] 307448 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307047 0
The Regional Ethical Review Board in Stockholm
Ethics committee address [1] 307047 0
Ethics committee country [1] 307047 0
Sweden
Date submitted for ethics approval [1] 307047 0
15/09/2016
Approval date [1] 307047 0
29/09/2016
Ethics approval number [1] 307047 0
DNr 2016/1789-32
Ethics committee name [2] 308446 0
Swedish Ethical Review Authority
Ethics committee address [2] 308446 0
Ethics committee country [2] 308446 0
Sweden
Date submitted for ethics approval [2] 308446 0
15/10/2020
Approval date [2] 308446 0
03/11/2020
Ethics approval number [2] 308446 0
DNr 2020-05528
Ethics committee name [3] 308447 0
Regional Ethics Review Board in Stockholm
Ethics committee address [3] 308447 0
Ethics committee country [3] 308447 0
Sweden
Date submitted for ethics approval [3] 308447 0
05/06/2013
Approval date [3] 308447 0
21/08/2013
Ethics approval number [3] 308447 0
DNr 2013/1078-31/2

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105838 0
Dr Tova Hannegard Hamrin
Address 105838 0
Pediatric Perioperative Medicine and Intensive Care
Astrid Lindgren Children's Hospital
Karolinska University Hospital, Solna Stockholm
S-171 76 Stockholm
Sweden
Country 105838 0
Sweden
Phone 105838 0
+46704971513
Fax 105838 0
Email 105838 0
[email protected]
Contact person for public queries
Name 105839 0
Tova Hannegard Hamrin
Address 105839 0
Pediatric Perioperative Medicine and Intensive Care
Astrid Lindgren Children's Hospital
Karolinska University Hospital, Solna Stockholm
S-171 76 Stockholm
Sweden
Country 105839 0
Sweden
Phone 105839 0
+46704971513
Fax 105839 0
Email 105839 0
[email protected]
Contact person for scientific queries
Name 105840 0
Tova Hannegard Hamrin
Address 105840 0
Pediatric Perioperative Medicine and Intensive Care
Astrid Lindgren Children's Hospital
Karolinska University Hospital, Solna Stockholm
S-171 76 Stockholm
Sweden
Country 105840 0
Sweden
Phone 105840 0
+46704971513
Fax 105840 0
Email 105840 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11547Ethical approval    380695-(Uploaded-03-05-2021-00-03-59)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIRisks for death after admission to pediatric intensive care (PICU)—A comparison with the general population2022https://doi.org/10.1371/journal.pone.0265792
N.B. These documents automatically identified may not have been verified by the study sponsor.