Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000071729
Ethics application status
Approved
Date submitted
4/12/2012
Date registered
18/01/2013
Date last updated
18/01/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Saline Versus Albumin Fluid Evaulation study - Extrapolation to Paediatric Intensive Care
Scientific title
An international, observational study of the choice of resucitation fluid used in children in intensive care.
Secondary ID [1] 281618 0
nil
Universal Trial Number (UTN)
U1111-1137-5682
Trial acronym
SAFE-EPIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shock 287900 0
Fluid administration 287901 0
Resuscitation 287902 0
Condition category
Condition code
Cardiovascular 288508 288508 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observation of type, volume and rate of resuscitation fluid administration and description of unit and patient factors in infants and children receiving a fluid resuscitation on the study day. All infants and children in participating intensive care units will be studied on each of two study dates (one in December 2012, and one in July 2013).
Intervention code [1] 286154 0
Not applicable
Comparator / control treatment
All infants and children in intensive care at 12:00 midday on the study days are included, regatrdless of whether they receive a fluid bolus.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288455 0
The global prevalence of fluid resuscitation in paediatric (0 to 16 years old (inclusive)) patients in intensive care. This outcome will be assessed by clinical assessments and observations made during the study period and from data available in the medical record.
Timepoint [1] 288455 0
Two study days (1 in summer and 1 in winter)
Secondary outcome [1] 300194 0
The effect of region on the use of colloids as the preferred fluid resuscitation bolus (assessed by clinical observation).
Timepoint [1] 300194 0
Two study days (summer and winter)

Eligibility
Key inclusion criteria
All newborns, infants or children aged 0 to 16 years (inclusive) in a participating intensive care unit at 12:00 midday on the study days.
Minimum age
0 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age 17 years or more

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/12/2012
Actual
4/12/2012
Date of last participant enrolment
Anticipated
2/07/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 438 0
The Children's Hospital at Westmead - Westmead
Recruitment outside Australia
Country [1] 4808 0
United Kingdom
State/province [1] 4808 0
London

Funding & Sponsors
Funding source category [1] 286425 0
Other Collaborative groups
Name [1] 286425 0
ANZICS Clinical Trials Group - Paediatric Study Group
Country [1] 286425 0
Australia
Primary sponsor type
Individual
Name
Dr Marino Festa
Address
Department of Paediatric Intensive Care
The Children's Hospital at westmead
Locked Bag 4001
Westmead
NSW 2145
Country
Australia
Secondary sponsor category [1] 285210 0
Other Collaborative groups
Name [1] 285210 0
ANZICS CTG: Paediatric Study Group
Address [1] 285210 0
10 Ievers Terrace
Carlton South
VIC AUSTRALIA 3053
Country [1] 285210 0
Australia
Other collaborator category [1] 277207 0
Charities/Societies/Foundations
Name [1] 277207 0
Critical Care and Trauma Division, The George Institute
Address [1] 277207 0
PO Box M201
Missenden Rd
NSW 2050
Country [1] 277207 0
Australia
Other collaborator category [2] 277209 0
Charities/Societies/Foundations
Name [2] 277209 0
The George institute - Division of Critical Care and Trauma
Address [2] 277209 0
PO Box M201 Missenden Rd
Sydney
NSW 2050
Country [2] 277209 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288505 0
Sydney Children's Hospitals Network Human Research Ethics Committee
Ethics committee address [1] 288505 0
Locked Bag 4001
Westmead
NSW2145
Ethics committee country [1] 288505 0
Australia
Date submitted for ethics approval [1] 288505 0
08/08/2012
Approval date [1] 288505 0
31/08/2012
Ethics approval number [1] 288505 0
09/CHW/53

Summary
Brief summary
Almost a decade ago, the SAFE study provided information on the effect of saline and albumin resuscitation fluids in adult patients in intensive care. Despite further studies, there remains a paucity of data on the most appropriate resuscitation fluid in infants and children in intensive care.

The SAFE Extrapolation to Paediatric Intensive Care (SAFE-EPIC) study is an international point prevalence study of fluid resuscitation practice in paediatric patients in intensive care. The SAFE-EPIC study aims to describe the type of fluid used and the patient and intensive care unit factors associated with the use of this fluid in paediatric patients (0 – 16 years) in registered intensive care sites in countries throughout the world on two study dates (one in December 2012, and one in July 2013).
Trial website
REDCap database, using this link: https://redcap.thegeorgeinstitute.org
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35010 0
Dr Marino Festa
Address 35010 0
Department of Paediatric Intensive Care
The Children's Hospital at Westmead
Locked Bag 4001
Westmead
NSW 2145
Country 35010 0
Australia
Phone 35010 0
+61 2 98451992
Fax 35010 0
+61 2 9845 1993
Email 35010 0
[email protected]
Contact person for public queries
Name 18257 0
Dr Marino Festa
Address 18257 0
Department of Paediatric Intensive Care
The Children's Hospital at Westmead
Locked Bag 4001
Westmead
NSW 2145
Country 18257 0
Australia
Phone 18257 0
+61298451992
Fax 18257 0
+61298451993
Email 18257 0
[email protected]
Contact person for scientific queries
Name 9185 0
Dr Marino Festa
Address 9185 0
Department of Paediatric Intensive Care
The Children's Hospital at Westmead
Locked Bag 4001
Westmead
NSW 2145
Country 9185 0
Australia
Phone 9185 0
+61298451992
Fax 9185 0
+61298451993
Email 9185 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23248Statistical analysis plan   

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.