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
ACTRN12618001383257
Ethics application status
Approved
Date submitted
12/06/2018
Date registered
17/08/2018
Date last updated
17/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Long and short time survival and causes of death in critically ill children after unplanned inter-hospital intensive care transport to a Pediatric Intensive Care Unit
Scientific title
Long and short time survival and causes of death in critically ill children after unplanned inter-hospital intensive care transport to a Pediatric Intensive Care Unit
Secondary ID [1] 295139 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness 308238 0
Condition category
Condition code
Public Health 307264 307264 0 0
Other public health

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
9
Target follow-up type
Years
Description of intervention(s) / exposure
In this observational study critically ill children (n=401) who were unplanned admitted to the PICU of a tertiary university hospital after being unplanned transported from a referring hospital were included. Study time was 9 years. Patients will be observed regarding long and short time survival, causes of death, predicted death ratio, length-of-stay in PICU, resource use in PICU and distance transported.
Intervention code [1] 301466 0
Diagnosis / Prognosis
Comparator / control treatment
Not applicable - observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306215 0
Pediatric Index of Mortality (PIM) and its derieved predicted death ratio (PDR)
Timepoint [1] 306215 0
At admission post-transport
Secondary outcome [1] 347898 0
PICU mortality
Timepoint [1] 347898 0
PICU mortality assessed retrospectively for duration of PICU stay
Secondary outcome [2] 347899 0
30 day mortality
Timepoint [2] 347899 0
Assessed retrospectively for 30 days post-PICU admission
Secondary outcome [3] 347900 0
Long time mortality
Timepoint [3] 347900 0
Assessed retrospectively for 9 years post-PICU admission
Secondary outcome [4] 350539 0
Resource use in PICU
Timepoint [4] 350539 0
Resource use in PICU assessed retrospectively from PDMS for duration of PICU stay. Patients in PICU are registred in a Patient Data Management System (PDMS) which is a computerised medical information system. Data are automatically collected from bedside medical devices, such as monitors, ventilators and infusion pumps.
Secondary outcome [5] 350540 0
Transport distance
Timepoint [5] 350540 0
At admission post-transport. Distance from the referring hospital to the PICU is calculated by an online distance calcualtor. If patients are transported by air a straight line is calculated in kilometres and if patients are transported on the ground, the distance by road is caculated.
Secondary outcome [6] 350541 0
Length-of-stay in PICU
Timepoint [6] 350541 0
Assessed retrospectively for duration of PICU stay. Patients are registred in a computerised medical information system when they are admitted to PICU and are also registred in the same system when they are discharged from PICU.
Secondary outcome [7] 350542 0
causes of death
Timepoint [7] 350542 0
Assessed retrospectively through the National Files of Registration and National Causes of Death Registry, which are separate national databases.

Eligibility
Key inclusion criteria
Consecutive critically ill children who had undergone an unplanned inter-hospital intensive care transport to the PICU of a tertiary university hospital by the hospital's specialized pediatric transport team.
Minimum age
No limit
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients not transported by the specialized pediatric transport team.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
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
10/10/2016
Date of last participant enrolment
Anticipated
Actual
31/12/2016
Date of last data collection
Anticipated
Actual
26/04/2018
Sample size
Target
400
Accrual to date
Final
401
Recruitment outside Australia
Country [1] 10537 0
Sweden
State/province [1] 10537 0

Funding & Sponsors
Funding source category [1] 299731 0
Government body
Name [1] 299731 0
Stockholms Läns Landsting. The County Council of Stockholm (Project 20130324)
Country [1] 299731 0
Sweden
Primary sponsor type
Hospital
Name
Karolinska University Hospital
Address
Pediatric Perioperative medicine and intensive care
Astrid Lindgren Childrens Hospital
Karolinska University Hospital, Solna Stockholm
S-171 76 Stockholm
Sweden
Country
Sweden
Secondary sponsor category [1] 299166 0
None
Name [1] 299166 0
Address [1] 299166 0
Country [1] 299166 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300621 0
The Regional Ethical Review Board in Stockholm
Ethics committee address [1] 300621 0
Ethics committee country [1] 300621 0
Sweden
Date submitted for ethics approval [1] 300621 0
07/06/2013
Approval date [1] 300621 0
21/08/2013
Ethics approval number [1] 300621 0
2013/1078-31/2 and 2016/1789-32

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

Contacts
Principal investigator
Name 84242 0
Dr Tova Hannegard Hamrin
Address 84242 0
Pediatric Perioperative Medicine and Intensive C,are
Astrid Lindgren Childrens Hospital
Karolinska University Hospital, Solna Stockholm
S-171 76 Stockholm
Country 84242 0
Sweden
Phone 84242 0
+46704971513
Fax 84242 0
Email 84242 0
[email protected]
Contact person for public queries
Name 84243 0
Tova Hannegard Hamrin
Address 84243 0
Pediatric Perioperative Medicine and Intensive Care
Astrid Lindgren Childrens Hospital
Karolinska University Hospital, Solna Stockholm
S-171 76 Stockholm
Country 84243 0
Sweden
Phone 84243 0
+46 8 51778285
Fax 84243 0
Email 84243 0
[email protected]
Contact person for scientific queries
Name 84244 0
Tova Hannegard Hamrin
Address 84244 0
Pediatric Perioperative Medicine and Intensive care
Astrid Lindgren Childrens Hospital
Karolinska University Hospital, Solna Stockholm
S-171 76 Stockholm
Country 84244 0
Sweden
Phone 84244 0
+46 8 51778285
Fax 84244 0
Email 84244 0
[email protected]

No information has been provided regarding IPD availability


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.