Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000754842
Ethics application status
Approved
Date submitted
16/07/2012
Date registered
16/07/2012
Date last updated
3/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Fluid therapy after cardiac surgery – A feasibility study
Scientific title
A study of cardiac surgical patients to determine if a stroke volume variation guided fluid protocol is superior to standard fluid administration in reducing the total amount of fluid patients receive.
Secondary ID [1] 280851 0
Nil
Universal Trial Number (UTN)
U1111-1132-5464
Trial acronym
FRACAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac surgery 286918 0
Condition category
Condition code
Cardiovascular 287245 287245 0 0
Other cardiovascular diseases
Surgery 287249 287249 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Stroke volume variation guided fluid administration. Bedside staff will utilise a protocol to guide fluid administration. If the clinician suspects the patient to have a known or suspected inadequate cardiac output (i.e. the cardiac index is < 2.5L/min/m2; poor perfusion;poor urine output) and the stroke voume is >13 then they will be instructed to administer a fluid bolus of 250mls. This will continue until the patient is extubated or they reach 24 hours post-operative.
Intervention code [1] 285277 0
Treatment: Other
Comparator / control treatment
Standard fluid administration - fluid boluses administered by the treating clinician based on blood pressure, central venous pressure etc. These boluses are usually 250 - 500mls per bolus and depend on the treating clinician.
Control group
Active

Outcomes
Primary outcome [1] 287527 0
Difference in the volume of fluid administered as a bolus during the first 24hrs post-op.
Timepoint [1] 287527 0
24 hours postoperative
Secondary outcome [1] 298330 0
Increase in serum NGAL
Timepoint [1] 298330 0
6 and 24hours postoperative
Secondary outcome [2] 298331 0
Incidence of acute kidney injury using RIFLE and AKIN catgories
Timepoint [2] 298331 0
Hospital stay
Secondary outcome [3] 298332 0
Requirment for renal replacement therapy
Timepoint [3] 298332 0
hospital stay
Secondary outcome [4] 298333 0
Intensive care unit length of stay
Timepoint [4] 298333 0
Discharge from ICU
Secondary outcome [5] 298334 0
Hospital length of stay
Timepoint [5] 298334 0
Discharge from hospital
Secondary outcome [6] 298335 0
Mortality
Timepoint [6] 298335 0
90days

Eligibility
Key inclusion criteria
Adult patients (>16yrs), expected to have cardiac surgery using cardiopulmonary bypass, written infomred consent
Minimum age
16 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Emergency procedure, intra-aortic balloon pump in situ, chronic atrial fibrillation pre-op, atrial fibrillation post-op, open chest post-op, patient likely to die within 24hours

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be consented and enrolled pre-operatively. As long as no exclusion criteria exist post-opertaively, patient will be randomised on return to ICU and allocation revealed. Randomisation will be acheived through use of sequentially numbered opaque envelopes which will contain patient allocation and study number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
These will be randomly generated using microsoft excel.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Patients will be stratified for presence/absence of a pulmonary artery catheter on admission to ICU.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2012
Actual
31/01/2013
Date of last participant enrolment
Anticipated
Actual
10/10/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
144
Accrual to date
Final
144
Recruitment outside Australia
Country [1] 4408 0
New Zealand
State/province [1] 4408 0
Auckland

Funding & Sponsors
Funding source category [1] 285636 0
Self funded/Unfunded
Name [1] 285636 0
Country [1] 285636 0
Primary sponsor type
Individual
Name
Dr Shay McGuinness
Address
Cardiothoracic and Vascular ICU
Auckland City Hospital
Private Bag 92024
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 284471 0
None
Name [1] 284471 0
Address [1] 284471 0
Country [1] 284471 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287636 0
Northern A ethics committee
Ethics committee address [1] 287636 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6011
Ethics committee country [1] 287636 0
New Zealand
Date submitted for ethics approval [1] 287636 0
13/07/2012
Approval date [1] 287636 0
21/09/2012
Ethics approval number [1] 287636 0
12/NTA/2

Summary
Brief summary
Following cardiac surgery, patients receive large amounts of fluid in the intensive care unit. This may cause problems with wound healing and delay hospital discharge. A planned randomised controlled trial of a restrictive fluid regime as compared to a more liberal approach utilising advance hemodynamic monitoring, aims to reduce the amount of fluid patients receive and reduce hospital length of stay. This feasibility study aims to determine whether this nurse-led protocol is practicable and feasible and will help answer the research question. It will also aim to evaluate how fluid is administered in other cardiac intensive care centres in New Zealand. This study is simple and inexpensive and if it demonstrates a decreased length of hospital stay then this will represent a significant benefit for both individual patients and the health system
Trial website
Trial related presentations / publications
This trial has been published as follows: Parke RL, McGuinness SP, Gilder E, McCarthy LW, Cowdrey K-AL. A Randomised feasibility study to assess a novel strategy to rationalise fluid in patients after cardiac surgery. British Journal of Anaesthesia 2015;115:45-52.
Public notes

Contacts
Principal investigator
Name 34440 0
Dr Shay McGuinness
Address 34440 0
Cardiothoracic and Vascular Intensive Care Unit Auckland CIty Hospital
Private Bag 92024
Auckland 1142
Country 34440 0
New Zealand
Phone 34440 0
+6421324771
Fax 34440 0
+6493074906
Email 34440 0
[email protected]
Contact person for public queries
Name 17687 0
Mrs Rachael Parke
Address 17687 0
Cardiothoracic and Vascular ICU
Auckland City Hospital
Private Bag 92024
Auckland 1142
Country 17687 0
New Zealand
Phone 17687 0
+6421893176
Fax 17687 0
+6493074906
Email 17687 0
[email protected]
Contact person for scientific queries
Name 8615 0
Dr Shay McGuinness
Address 8615 0
Cardiothoracic and Vascular ICU
Auckland City Hospital
Private Bag 92024
Auckland 1142
Country 8615 0
New Zealand
Phone 8615 0
+6421324771
Fax 8615 0
+6493074906
Email 8615 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
SourceTitleYear of PublicationDOI
EmbaseA Randomised feasibility study to assess a novel strategy to rationalise fluid in patients after cardiac surgery.2015https://dx.doi.org/10.1093/bja/aev118
N.B. These documents automatically identified may not have been verified by the study sponsor.