Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000462482
Ethics application status
Approved
Date submitted
31/08/2007
Date registered
12/09/2007
Date last updated
18/11/2019
Date data sharing statement initially provided
18/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fluid Responsiveness in Septic Shock
Scientific title
To assess the change in cardiac output from clinical fluid challenge in patients with septic shock.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Septic shock. 2312 0
Condition category
Condition code
Cardiovascular 2414 2414 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
Clinically administered fluid challenge (250mL colloid intravenous infusion over 15 minutes at request of treating clinician).
Participation in each study will take approximately 30 minutes of participant time.
Intervention code [1] 2034 0
Not applicable
Comparator / control treatment
Nil.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3312 0
Correlation between baseline variables and subsequent increase in cardiac output (measured by USCOM).
Timepoint [1] 3312 0
Immediateley before and after fluid challenge.
Secondary outcome [1] 5519 0
Increase in cardiac output (measured by USCOM) of equal to or greater than 15%.
Timepoint [1] 5519 0
Immediately after fluid challenge.

Eligibility
Key inclusion criteria
Intensive care unit patients diagnosed with septic shock where fluid challenge is clinically requested.
Septic shock will be defined in terms of the International Sepsis Definitions Conference [American College of Chest Physicians/Society of Critical Care Medicine
Consensus Conference: definitions for sepsis and organ failure and guidelines
for the use of innovative therapies in sepsis. Crit Care Med 1992;20(6):864-74].
Minimum age
18 Years
Maximum age
N/A
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Treating clinician or patient/legally authorised representative decline participation/consent. Age <18 years at time of eligibility, presence of moderate to severe valve disease, evidence of fluid overload (such as impaired gas exchange or radiographic evidence of pulmonary oedema).

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/08/2007
Actual
1/09/2007
Date of last participant enrolment
Anticipated
Actual
31/12/2007
Date of last data collection
Anticipated
Actual
31/12/2007
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2578 0
Other
Name [1] 2578 0
Australian And New Zealand College of Anaesthetists
Country [1] 2578 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
The University of Queensland
Brisbane QLD 4072
Country
Australia
Secondary sponsor category [1] 2328 0
Hospital
Name [1] 2328 0
Wesley Hospital
Address [1] 2328 0
451 Coronation Drive
Auchenflower QLD 4066
Country [1] 2328 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4495 0
Uniting Healthcare Human Research Ethics Committee
Ethics committee address [1] 4495 0
Ethics committee country [1] 4495 0
Australia
Date submitted for ethics approval [1] 4495 0
Approval date [1] 4495 0
22/06/2007
Ethics approval number [1] 4495 0
2007/36

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

Contacts
Principal investigator
Name 28019 0
Address 28019 0
Country 28019 0
Phone 28019 0
Fax 28019 0
Email 28019 0
Contact person for public queries
Name 11176 0
Dr David Sturgess
Address 11176 0
451 Coronation Drive
Auchenflower QLD 4066
Country 11176 0
Australia
Phone 11176 0
+61 7 32327000
Fax 11176 0
Email 11176 0
s3316247@student.uq.edu.au
Contact person for scientific queries
Name 2104 0
Dr David Sturgess
Address 2104 0
451 Coronation Drive
Auchenflower QLD 4066
Country 2104 0
Australia
Phone 2104 0
+61 7 32327000
Fax 2104 0
Email 2104 0
s3316247@student.uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.