Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000085471
Ethics application status
Approved
Date submitted
20/09/2006
Date registered
25/01/2007
Date last updated
25/01/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to assess the safety and efficacy of Navigator in post operative cardiac surgery patients versus conventional care.
Scientific title
AP2006-1: A prospective, randomised, multicentre, controlled group study to assess the safety and efficacy of Navigator versus conventional care in post operative cardiac surgery patients undergoing coronary bypass grafting and / or heart valve repair or replacement whilst utilising heart lung perfusion pump.
Universal Trial Number (UTN)
Trial acronym
NAV-1 Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elective cardiac bypass grafting and / or heart valve repair or replacement whilst utilising heart lung perfusion pump. 1578 0
Condition category
Condition code
Cardiovascular 1680 1680 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Post operative cardiac patients entering the Intensive Care will be connected to the Navigator device with real-time data displayed in a graphical manner. The Navigator device will be connected until the Swan-Ganz catheter is removed. This is most commonly on day 2 after surgery, but could be as long as 7 days.
Intervention code [1] 1352 0
Other interventions
Comparator / control treatment
Post operative cardiac patients entering the Intensive Care will be connected to the Navigator device but without real-time data displayed in a graphical manner. The Navigator device will be connected until the Swan-Ganz catheter is removed. This is most commonly on day 2 after surgery, but could be as long as 7 days.
Control group
Active

Outcomes
Primary outcome [1] 2325 0
Average distance to the central point of the physician-prescribed target cardiovascular zone over the period that the patient is connected to Navigator.
Timepoint [1] 2325 0
This will most commonly be on day 2 after surgery, but, dependent on speed of recovery, may be up to and beyond 7 days.
Secondary outcome [1] 4060 0
1) Percentage time in the physician-nominated target cardiovascular zone
Timepoint [1] 4060 0
over the period of time that the patient is connected to Navigator, usually over 2 days, but may be up to or more than 7 days
Secondary outcome [2] 4061 0
2) clinically significant atrial fibrillation (AF)
Timepoint [2] 4061 0
over the period the patient is connected to Navigator, usually for 2 days post-surgery, but may be up to or more than 7 days, depending on speed of recovery
Secondary outcome [3] 4062 0
3) Multiple organ function, as assessed using the SOFA score
Timepoint [3] 4062 0
calculated daily over the period the patient is hospitalised, usually for 5 days, but could be up to 10 days in cases of slow recovery
Secondary outcome [4] 4063 0
4) Navigator device related adverse events and device failures.
Timepoint [4] 4063 0

Eligibility
Key inclusion criteria
Who provide written informed consent and are about to undergo elective heart surgery requiring heart lung perfusion pump. Eligible patients will emerge from surgery with an arterial line and Swan Ganz catheter in situ and must require invasive measurement of cardiac output, mean arterial pressure and right atrial pressure.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will not be eligible for inclusion if the require extracorporeal membrane oxygenation, or have permenant pace makers or left ventircular assist devices in situ. A history of or pre-randomisation event of atrial fibrillation and/or intra-operative surgical treatment for atrial fibrillation will exclude patients from the study. Simillarly if the investigator deems the patient unco-operative or unsuitable for inclusion or considers an exisiting medical condition renders participation unsafe for the patient they will be excluded from the study. Patients will also be excluded if they are involved in another drug/device study or if they are pregnant or lactating females.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central Randomisation by Phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
1:1 randomisation using a computer generated randomisation table and stratified by site and history of atrial fibrillation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
multi-centre
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/10/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1825 0
Commercial sector/Industry
Name [1] 1825 0
Applied Physiology Pty Limited
Country [1] 1825 0
Primary sponsor type
Commercial sector/Industry
Name
Applied Physiology Pty Limited
Address
119 Willoughby Road
Crows Nest NSW 2065
Country
Australia
Secondary sponsor category [1] 1645 0
None
Name [1] 1645 0
Nil
Address [1] 1645 0
Country [1] 1645 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3416 0
St George Hospital, Sydney
Ethics committee address [1] 3416 0
Ethics committee country [1] 3416 0
Australia
Date submitted for ethics approval [1] 3416 0
Approval date [1] 3416 0
14/11/2006
Ethics approval number [1] 3416 0
2006/100 Horton
Ethics committee name [2] 3417 0
Alfred Hospital, Melbourne
Ethics committee address [2] 3417 0
Ethics committee country [2] 3417 0
Australia
Date submitted for ethics approval [2] 3417 0
Approval date [2] 3417 0
08/01/2007
Ethics approval number [2] 3417 0
229/06
Ethics committee name [3] 3418 0
St Vincent's Hospital, Sydney
Ethics committee address [3] 3418 0
Ethics committee country [3] 3418 0
Australia
Date submitted for ethics approval [3] 3418 0
Approval date [3] 3418 0
27/11/2006
Ethics approval number [3] 3418 0
H06/127

Summary
Brief summary
Post surgical patients often display instability in their blood pressure and flow (haemodynamic circulation) which, if not stabilized, can lead to a range of side effects such as reduced urine output, kidney failure, fluid in the lungs, disorganized and ineffective pumping of the blood by the heart, and stroke. These side effects usually require an extended hospital stay, additional investigations and medications, and all lead to additional cost. Navigator software has been developed to link with the patient’s bedside monitor and acquire and process data collected by the monitor. This data is then displayed graphically relative to target ranges for a variety of heart measurements that were determined by the physician specifically for the patient and entered into Navigator at the start of monitoring. This provides the physician with a real time picture of the patient’s blood pressure and flow, in comparison to the prescribed values he would like to achieve and provides unique guidance as to what fluid and medication treatments could be administered to make the patient more stable.
The aim of the study is to demonstrate that the real time acquisition and subsequent processing and display of data produced by Navigator provides the clinician with appropriate data and guidance to achieve and maintain a prescribed target blood pressure and flow stability in the post operative patient when compared to conventional care in an ICU setting.
The study will be conducted in 100 post-cardiac surgery patients male and female aged 18 and over that have undergone coronary bypass grafting and/or heart valve repair or replacement whilst utilizing heart lung perfusion pump (50 patients per study group).
Patients that meet all of the inclusion / exclusion criteria will have a 50:50 chance of being randomized to one of two study groups, Navigator or control (conventional care). All patients will be connected to a bedside monitor which in turn is connected to an Avantech computer with the Navigator software installed. Those patients randomized to the Navigator group will have the full Navigator functions available; for those patients randomized to the control group the physician will still determine target values for the heart measurements, however once control is selected on the Navigator screen the graphical part of the screen will go blank. Each patient will be connected to Navigator for as long as their doctor wishes to have their heart function closely monitored by their heart catheter. Once this catheter is removed, Navigator will be disconnected. This will be between the day after surgery and around a week after surgery, depending on the speed of recovery.
All patients will undergo standard treatments during their hospital stay.
The aim of this study therefore, is to demonstrate that real time aquisition and subsequent processing and display of data produced by Navigator provides the clinican with the appropriate data and guidance to acheive and maintain a prescribed target haemodynamic stability in the post operative patient when compared to conventional care in an ICU setting. Acheiving early haemodynamic stability in the post operative cardiac patient as it is hoped will lead to improved patient outcome and reduced associated costs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27959 0
Address 27959 0
Country 27959 0
Phone 27959 0
Fax 27959 0
Email 27959 0
Contact person for public queries
Name 10541 0
Louise Hayman, Senior Partner
Address 10541 0
Trident Clinical Research Pty Limited, Suite 204, 27 Merriwa Street, Gordon, NSW 2072
Country 10541 0
Australia
Phone 10541 0
+61 2 94999996
Fax 10541 0
+61 2 94999998
Email 10541 0
[email protected]
Contact person for scientific queries
Name 1469 0
Dr Geoffrey Parkin
Address 1469 0
Medical Director, Applied Physiology Pty Limited, 119 Willoughby Road, Crows Nest, NSW 2065
Country 1469 0
Australia
Phone 1469 0
+61 418582281
Fax 1469 0
+61 2 94392157
Email 1469 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

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