Registration Enabling Study of the Safety and Efficacy of the Use of the Navigator Circulatory Management System - Full Text View

Sponsor:	Applied Physiology Pty Ltd
Collaborator:	Trident Clinical Research Pty Ltd
Information provided by:	Applied Physiology Pty Ltd
ClinicalTrials.gov Identifier:	NCT00468247

Purpose

A multicentre, open, RCT to assess the safety and efficacy of the Navigator Guided Circulatory Management System versus conventional care in post-operative cardiac surgery patients. The purpose of the study is to demonstrate that the real time acquisition and subsequent processing and display of data produced by the Navigator guided circulatory management system provides the clinician with appropriate data and guidance to achieve and maintain a prescribed target haemodynamic stability in the post operative patient when compared to conventional care in an Intensive Care Unit setting.

Condition	Intervention	Phase
Critical Illness Intensive Care	Device: Navigator Other: Conventional care	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Prospective,Open,Multicentre,RCT to Assess the Safety & Efficacy of Navigator v Conventional Care in Post-op Cardiac Surgery Patients Undergoing CABG &/or Heart Valve Repair/Replacement Utilising Heart Lung Perfusion Pump(The NAV-1 Study)

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery

U.S. FDA Resources

Further study details as provided by Applied Physiology Pty Ltd:

Primary Outcome Measures:

Average distance to central point of the target cardiovascular zone while connected to the device [ Time Frame: Time connected to Navigator device ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage time in the target cardiovascular zone while connected to device [ Time Frame: Time connected to Navigator device ] [ Designated as safety issue: No ]
Clinically significant AF while connected to device [ Time Frame: Time connected to Navigator device ] [ Designated as safety issue: No ]
Multiple organ function (SOFA score) [ Time Frame: From connection to Navigator device to hospital discharge ] [ Designated as safety issue: Yes ]
Device-related adverse events and device failures [ Time Frame: Time connected to Navigator device ] [ Designated as safety issue: Yes ]

Enrollment:	112
Study Start Date:	March 2007
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Device , Navigator used for guiding haemodynamic care	Device: Navigator Navigator circulatory mgt system
Placebo Comparator: 2 Conventional care	Other: Conventional care Conventional haemodynamic care

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female aged 18 years or older
Undergoing elective cardiac surgery where surgery involves the use of a heart-lung perfusion pump
Will have an arterial line and Swan Ganz catheter in situ
Require invasive measurement of Cardiac Output (CO), Mean Arterial Pressure (MAP) and Right Atrial Pressure (RAP)
Are able and willing to provide written informed consent to participate in the study

Exclusion Criteria:

Women who are lactating or pregnant
Require Extracorporeal Membrane Oxygenation
Present at baseline screening or immediately prior to randomisation in the ICU with atrial fibrillation (irregular supraventricular rhythm, not due to ectopic complexes with an absence of discrete P-waves lasting more than 10 minutes documented and confirmed with an ECG)
Intra-operative surgical treatment for atrial fibrillation
Surgery for left atrial reduction
Patients with left ventricular assist devices
Patients with permanent pacemakers in situ
Deemed by the investigator to be uncooperative or unsuitable for inclusion into this trial
Have a medical condition that in the opinion of the investigator would jeopardise the patient's safety by participating in this trial
Current participation in another drug or device study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468247

Locations

Australia, New South Wales
Westmead Private Hospital
Sydney, New South Wales, Australia, 2145
Westmead Public Hospital
Sydney, New South Wales, Australia, 2145
St George Public Hospital
Sydney, New South Wales, Australia, 2217
St Vincent's Public Hospital
Sydney, New South Wales, Australia, 2010
Royal North Shore Hospital
Sydney, New South Wales, Australia, 2065
Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3181
Monash Medical Centre
Melbourne, Victoria, Australia, 3168

Sponsors and Collaborators

Applied Physiology Pty Ltd

Trident Clinical Research Pty Ltd

Investigators

Principal Investigator:	Yugan Mudaliar, PhD	Western Sydney Area Health Service
Study Director:	Geoff Parkin, PhD	Monash Medical Centre

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

Parkin WG. Volume state control - a new approach. Crit Care Resusc. 1999 Sep;1(3):311-21.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pellegrino VA, Mudaliar Y, Gopalakrishnan M, Horton MD, Killick CJ, Parkin WG, Playford HR, Raper RF. Computer based haemodynamic guidance system is effective and safe in management of postoperative cardiac surgery patients. Anaesth Intensive Care. 2011 Mar;39(2):191-201.

Responsible Party:	Vickie Edwards, Applied Physiology Pty Ltd
ClinicalTrials.gov Identifier:	NCT00468247 History of Changes
Other Study ID Numbers:	AP2006-01
Study First Received:	April 30, 2007
Last Updated:	April 24, 2008
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Applied Physiology Pty Ltd:

mean systemic pressure
fluid therapy
closed loop control
circulation modelling

Additional relevant MeSH terms:

Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012