Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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
ACTRN12613001172796
Ethics application status
Approved
Date submitted
4/10/2013
Date registered
24/10/2013
Date last updated
29/04/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The Fluid Translation of Research into Practice Study (Fluid-TRIPS): An International Cross-Sectional Survey of Fluid Resuscitation Practice in Intensive Care Unit Patients

Scientific title
Translating reliable evidence on fluid resuscitation of intensive care patients into clinical practice – Improving patient outcomes and containing public health costs
Secondary ID [1] 283358 0
Nil
Universal Trial Number (UTN)
U1111-1148-7823
Trial acronym
Fluid-TRIPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
fluid resuscitation in intensive care unit 290254 0
Condition category
Condition code
Public Health 290645 290645 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
An international cross-sectional survey will be undertaken which audits fluid resuscitation practice in participating ICUs on a single day.
Intervention code [1] 288082 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290662 0
To describe the amount and type of resuscitation fluid currently administered to adult patients in intensive care units (ICU) in different countries
Timepoint [1] 290662 0
Data will be collected over a designated 24-hour study day
Secondary outcome [1] 304990 0
To describe and compare the costs of fluid choice between different geographical regions
Timepoint [1] 304990 0
Data will be collected over a designated 24-hour study day

Eligibility
Key inclusion criteria
Adult patients present in the ICU at the 10am census at the start of on the study day or admitted during the 24-hour study period will be included in the study sample.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children under 16 years are excluded

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/04/2014
Actual
30/04/2014
Date of last participant enrolment
Anticipated
10/12/2014
Actual
10/12/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
2100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 5465 0
New Zealand
State/province [1] 5465 0
Country [2] 5466 0
Belgium
State/province [2] 5466 0
Country [3] 5467 0
Brazil
State/province [3] 5467 0
Country [4] 5469 0
China
State/province [4] 5469 0
Country [5] 5470 0
Denmark
State/province [5] 5470 0
Country [6] 5471 0
Finland
State/province [6] 5471 0
Country [7] 5472 0
France
State/province [7] 5472 0
Country [8] 5473 0
Germany
State/province [8] 5473 0
Country [9] 5474 0
Canada
State/province [9] 5474 0
Country [10] 5475 0
Netherlands
State/province [10] 5475 0
Country [11] 5476 0
Saudi Arabia
State/province [11] 5476 0
Country [12] 5477 0
Sweden
State/province [12] 5477 0
Country [13] 5478 0
United Kingdom
State/province [13] 5478 0
Country [14] 5479 0
United States of America
State/province [14] 5479 0
Country [15] 5480 0
Viet Nam
State/province [15] 5480 0
Country [16] 5481 0
India
State/province [16] 5481 0
Country [17] 5482 0
Iceland
State/province [17] 5482 0

Funding & Sponsors
Funding source category [1] 288086 0
Other
Name [1] 288086 0
The George Institute for global health; Critical Care & Trauma Division
Country [1] 288086 0
Australia
Primary sponsor type
Other
Name
The George Institute for global health
Address
Level 13 321 Kent Street Sydney NSW 2000 Australia
Country
Australia
Secondary sponsor category [1] 286809 0
None
Name [1] 286809 0
Not applicable
Address [1] 286809 0
Not applicable
Country [1] 286809 0
Other collaborator category [1] 277666 0
Individual
Name [1] 277666 0
Colman Taylor (Co-Principle Investigator)
Address [1] 277666 0
The George Institute for Global Health
Critical Care and Trauma Division

Level 13 321 Kent Street Sydney NSW 2000
Country [1] 277666 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290012 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 290012 0
Research Development Office
Suite 210A
RPAH Medical Centre
100 Carillon Avenue
NEWTOWN NSW 2042
Ethics committee country [1] 290012 0
Australia
Date submitted for ethics approval [1] 290012 0
16/12/2013
Approval date [1] 290012 0
17/04/2014
Ethics approval number [1] 290012 0
EC00152

Summary
Brief summary
The objective of this project is to describe international trends in the prescription of intravenous fluids for fluid resuscitation in intensive care and to determine the major drivers of choice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43462 0
Ms Naomi Hammond
Address 43462 0
The George institute for global health
Critical Care and Trauma Division,
Level 13
321 Kent Street
Sydney NSW 2000 Australia
Country 43462 0
Australia
Phone 43462 0
61 2 9657 0352
Fax 43462 0
Email 43462 0
[email protected]
Contact person for public queries
Name 43463 0
Maryam Correa
Address 43463 0
The George institute for global health
Critical Care and Trauma Division,
Level 13
321 Kent Street
Sydney NSW 2000
Country 43463 0
Australia
Phone 43463 0
61 2 82382467
Fax 43463 0
Email 43463 0
[email protected]
Contact person for scientific queries
Name 43464 0
Maryam Correa
Address 43464 0
The George institute for global health
Critical Care and Trauma Division,
Level 13
321 Kent Street
Sydney NSW 2000
Country 43464 0
Australia
Phone 43464 0
61 2 82382467
Fax 43464 0
Email 43464 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.