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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.

Condition category

Condition code

Cardiovascular

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]

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]

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]

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]

1) Percentage time in the physician-nominated target cardiovascular zone

Timepoint [1]

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]

2) clinically significant atrial fibrillation (AF)

Timepoint [2]

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]

3) Multiple organ function, as assessed using the SOFA score

Timepoint [3]

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]

4) Navigator device related adverse events and device failures.

Timepoint [4]

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?

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]

Commercial sector/Industry

Name [1]

Applied Physiology Pty Limited

Address [1]

Country [1]

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]

None

Name [1]

Nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St George Hospital, Sydney

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

14/11/2006

Ethics approval number [1]

2006/100 Horton

Ethics committee name [2]

Alfred Hospital, Melbourne

Ethics committee address [2]

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

08/01/2007

Ethics approval number [2]

229/06

Ethics committee name [3]

St Vincent's Hospital, Sydney

Ethics committee address [3]

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

Approval date [3]

27/11/2006

Ethics approval number [3]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Louise Hayman, Senior Partner

Address

Trident Clinical Research Pty Limited, Suite 204, 27 Merriwa Street, Gordon, NSW 2072

Country

Australia

Phone

+61 2 94999996

Fax

+61 2 94999998

[email protected]

Contact person for scientific queries

Name

Dr Geoffrey Parkin

Address

Medical Director, Applied Physiology Pty Limited, 119 Willoughby Road, Crows Nest, NSW 2065

Country

Australia

Phone

+61 418582281

Fax

+61 2 94392157

[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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Documents added automatically

No additional documents have been identified.

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