Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000405617
Ethics application status
Approved
Date submitted
9/09/2005
Date registered
14/09/2005
Date last updated
13/11/2019
Date data sharing statement initially provided
13/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Fluid responsiveness after cardiac surgery
Scientific title
Bedside prediction of fluid responsiveness in mechanically ventilated patients following coronary artery bypass grafting.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients admitted to the Intensive Care Unit following Coronary Artery Bypass Grafting (CABG). 511 0
Condition category
Condition code
Cardiovascular 589 589 0 0
Coronary heart disease
Surgery 590 590 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brain natriuretic peptide assay, transthoracic and transoesophageal echocardiography, clinical data and waveform analysis (including PaOP, CVP, pulse pressure variation and systolic pressure variation) will be performed immediately before and after rapid infusion of intravenous colloid solution.
Intervention code [1] 423 0
Diagnosis / Prognosis
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 685 0
An increase in mean cardiac output, as determined by pulmonary artery catheter thermodilution, by equal to or greater than 10% within half an hour of rapid intravenous fluid administration compared with immediately before fluid administration.
Timepoint [1] 685 0
30 minutes
Secondary outcome [1] 1401 0
The impact of varying positive end expiratory pressure (PEEP).
Timepoint [1] 1401 0
Preload and afterload upon measured variables will be assessed.

Eligibility
Key inclusion criteria
Patient booked for CABG surgery.Left ventricular ejection fraction greater than 40% pre-operatively (as determined by echocardiography or radiocontrast ventriculography).Normal cardiac valvular function (defined as mitral or aortic valve regurgitation less than 2+ on echocardiography).Normal respiratory function (defined as absence of documented respiratory pathology or FEV1/FVC greater than or equal to 60%).Absence of oesophageal pathology that would contraindicate transoesophageal echocardiography.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ECG demonstrates rhythm other than sinus rhythm or AAI pacing post-operatively.Pulmonary hypertension (defined as pulmonary systolic blood pressure greater than 50mmHg as estimated by echocardiography pre-operatively or by pulmonary artery catheter at the time of insertion).Blood loss greater than 250mL in the first hour post-operatively.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
8/11/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 643 0
University
Name [1] 643 0
University of Queensland
Country [1] 643 0
Australia
Funding source category [2] 644 0
Hospital
Name [2] 644 0
Queensland Health (Princess Alexandra Hospital)
Country [2] 644 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
The University of Queensland, Brisbane, Queensland, Australia 4072
Country
Australia
Secondary sponsor category [1] 540 0
Hospital
Name [1] 540 0
Princess Alexandra Hospital
Address [1] 540 0
Woolloongabba, Queensland, Australia
Country [1] 540 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304731 0
Princess Alexandra Hospital Human Research Ethics Committee
Ethics committee address [1] 304731 0
Ipswich Road
Woolloongabba Q 4102
Ethics committee country [1] 304731 0
Date submitted for ethics approval [1] 304731 0
04/04/2006
Approval date [1] 304731 0
06/04/2006
Ethics approval number [1] 304731 0
2006/045

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

Contacts
Principal investigator
Name 36125 0
Address 36125 0
Country 36125 0
Phone 36125 0
Fax 36125 0
Email 36125 0
Contact person for public queries
Name 9612 0
Dr David Sturgess
Address 9612 0
School of Medicine
Southern Division
University of Queensland
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 9612 0
Australia
Phone 9612 0
+61 7 32402111
Fax 9612 0
Email 9612 0
[email protected]
Contact person for scientific queries
Name 540 0
Dr David Sturgess
Address 540 0
School of Medicine
Southern Division
University of Queensland
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 540 0
Australia
Phone 540 0
+61 7 32402111
Fax 540 0
Email 540 0
[email protected]

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.