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Sponsors and Collaborators: |
Applied Physiology Pty Ltd Trident Clinical Research Pty Ltd |
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Information provided by: | Applied Physiology Pty Ltd |
ClinicalTrials.gov Identifier: | NCT00468247 |
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 |
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Critical Illness Intensive Care |
Device: Navigator Other: Conventional care |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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) |
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 |
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1: Active Comparator
Device , Navigator used for guiding haemodynamic care
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Device: Navigator
Navigator circulatory mgt system
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2: Placebo Comparator
Conventional care
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Other: Conventional care
Conventional haemodynamic care
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Yugan Mudaliar, PhD | Western Sydney Area Health Service |
Study Director: | Geoff Parkin, PhD | Monash University |
Responsible Party: | Applied Physiology Pty Ltd ( Vickie Edwards ) |
Study ID Numbers: | AP2006-01 |
Study First Received: | April 30, 2007 |
Last Updated: | April 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00468247 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
mean systemic pressure fluid therapy closed loop control circulation modelling |
Critical Illness |
Disease Attributes Pathologic Processes |