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Trial registered on ANZCTR


Registration number
ACTRN12618001693213
Ethics application status
Approved
Date submitted
8/10/2018
Date registered
15/10/2018
Date last updated
16/03/2020
Date data sharing statement initially provided
16/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A protocol to standardise intravenous fluid therapy after cardiac surgery
Scientific title
Use of a mean systemic filling pressure analogue in ICU (Intensive Care Unit) patients post-cardiac surgery to guide fluid resuscitation and aim to reduce total amount of intravenous fluid administered until extubation.
Secondary ID [1] 296283 0
Nil known
Universal Trial Number (UTN)
U1111-1221-9878
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-cardiac surgery 309957 0
Condition category
Condition code
Cardiovascular 308731 308731 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Introduction of a protocol to guide intravenous fluid resuscitation post cardiac surgery based on calculation of the "mean systemic filling pressure analogue" (Pmsa).

Before-and-after trial comparing data after introduction of protocol to previously collected (retrospective) data from an earlier quality assurance audit, with the aim to reduce the amount of IV fluid administered post-operatively.

Participants will be recruited upon arrival into the ICU immediately post-operatively. The Pmsa is calculated on arrival and then every 2 hours, or if the patient is not meeting MAP (mean arterial pressure) and CO (cardiac output) targets and the most recent Pmsa is more than 15 minutes old.

The Pmsa is calculated from use of a Swan-Ganz catheter and the below equation:
Pmsa = aCVP + bMAP + cCO
where a = 0.96, b = 0.04 and c is determined from patient anthropometrics (height and weight).
A spreadsheet will be loaded to the bedside computer with formulas for calculation, and at each time for calculation a CO will be measured by thermodilution using the Swan-Ganz catheter. The values for height, weight, MAP, CVP, and CO are entered into the spreadsheet to calculate Pmsa.

The Pmsa is calculated regularly to guide fluid management, and treating clinician's are advised to avoid further IV fluid boluses once the Pmsa is above 17 (based on previous studies showing a Pmsa of 17 or higher indicates fluid non-responsiveness).

This will be conducted by the bedside nurse and treating clinician (registrar/consultant) for each patient post-cardiac surgery in a tertiary ICU. Education will be provided on implementing the protocol and chart review will occur to determine compliance. Any consultants who do not wish to enrol a patient will be required to provide a reason for future inclusion/exclusion criteria.
Intervention code [1] 312614 0
Prevention
Comparator / control treatment
The comparator is standard post-operative care where IV fluid administration is determined by the treating clinician without reference to the Pmsa.
This will be examined by a retrospective review of current standard care and amount of IV fluid administered (and relevant outcomes) over the past 12 months. (This is currently underway as part of an internal quality assurance project).
Control group
Historical

Outcomes
Primary outcome [1] 307720 0
Volume of IV fluid administered until extubation, which will be collected from bedside chart recording (hourly fluid input and cumulative total routinely recorded)
Timepoint [1] 307720 0
At time of extubation post-cardiac surgery
Secondary outcome [1] 352632 0
Urine output
Collected from bedside chart (hourly urine output routinely recorded and cumulatively totaled)
Timepoint [1] 352632 0
Day 0, Day 1 and Day 2 post-operatively
Secondary outcome [2] 352633 0
Plasma creatinine level
Timepoint [2] 352633 0
Day 1 and Day 2 post-op
Secondary outcome [3] 352634 0
Peak inotrope requirement (eg Adrenaline infusion, mcg/min)
Collected from bedside chart (routinely recorded)
Timepoint [3] 352634 0
From time of admission to time of extubation
Secondary outcome [4] 352635 0
Time to extubation
-Collected from time of admission to time of extubation, which are both routinely recorded on the bedside chart
Timepoint [4] 352635 0
From time of admission to time of extubation (both routinely recorded on bedside charts)
Secondary outcome [5] 352724 0
Peak vasopressor requirement (eg Noradrenaline infusion, mcg/min)
Collected from bedside chart (routinely recorded)
Timepoint [5] 352724 0
Over admission, from time of admission until time of extubation

Eligibility
Key inclusion criteria
Elective cardiac surgery patients admitted to ICU post-operatively, including:
-Coronary Artery Bypass Graft Surgery
-Valve Surgery
-Combined Coronary Artery Bypass Graft and Valve Surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Emergency surgery
Pregnancy
Age less than 18 years old
Cardiac surgery involving the ascending aorta

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Other
Other design features
A historical control group is being retrospectively analysed separately. The amount of fluid given via "standard-care" before introduction of the protocol will be determined, along with the above secondary outcomes based on bedside chart review.

Prospectively, eligible patients will be able to be recruited consecutively to this study protocol and then compared to the historical control group.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis planned with multivariate analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/11/2018
Actual
2/06/2019
Date of last participant enrolment
Anticipated
Actual
31/07/2019
Date of last data collection
Anticipated
Actual
30/09/2019
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12121 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 24290 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 300895 0
Hospital
Name [1] 300895 0
Monash Health - Monash Medical Centre
Country [1] 300895 0
Australia
Primary sponsor type
Hospital
Name
Monash Medical Centre
Address
Monash Medical Centre
246 Clayton Road
Clayton, VIC 3168
Country
Australia
Secondary sponsor category [1] 300439 0
Individual
Name [1] 300439 0
Justin Rheese
Address [1] 300439 0
Monash Medical Centre
246 Clayton Road
Clayton, VIC 3168
Country [1] 300439 0
Australia
Other collaborator category [1] 280386 0
Individual
Name [1] 280386 0
Adrian Pakavakis
Address [1] 280386 0
Monash Medical Centre
246 Clayton Road
Clayton, VIC 3168
Country [1] 280386 0
Australia
Other collaborator category [2] 280387 0
Individual
Name [2] 280387 0
William Geoffrey Parkin
Address [2] 280387 0
Monash Medical Centre
246 Clayton Road
Clayton, VIC 3168
Country [2] 280387 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301650 0
Monash Health HREC
Ethics committee address [1] 301650 0
Ethics committee country [1] 301650 0
Australia
Date submitted for ethics approval [1] 301650 0
14/10/2018
Approval date [1] 301650 0
21/01/2019
Ethics approval number [1] 301650 0
Ethics committee name [2] 305603 0
Monash Health HREC
Ethics committee address [2] 305603 0
Ethics committee country [2] 305603 0
Australia
Date submitted for ethics approval [2] 305603 0
22/10/2018
Approval date [2] 305603 0
21/01/2019
Ethics approval number [2] 305603 0
44894

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

Contacts
Principal investigator
Name 87658 0
Dr Justin Rheese
Address 87658 0
Monash Medical Centre
246 Clayton Road
Clayton, VIC 3168
Country 87658 0
Australia
Phone 87658 0
+61 408435260
Fax 87658 0
Email 87658 0
justin.rheese@monashhealth.org
Contact person for public queries
Name 87659 0
Justin Rheese
Address 87659 0
Monash Medical Centre
246 Clayton Road
Clayton, VIC 3168
Country 87659 0
Australia
Phone 87659 0
+61 408435260
Fax 87659 0
Email 87659 0
justin.rheese@monashhealth.org
Contact person for scientific queries
Name 87660 0
Justin Rheese
Address 87660 0
Monash Medical Centre
246 Clayton Road
Clayton, VIC 3168
Country 87660 0
Australia
Phone 87660 0
+61 408435260
Fax 87660 0
Email 87660 0
justin.rheese@monashhealth.org

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


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.