Status:
COMPLETED
Registration Enabling Study of the Safety and Efficacy of the Use of the Navigator Circulatory Management System
Lead Sponsor:
Applied Physiology Pty Ltd
Collaborating Sponsors:
Trident Clinical Research Pty Ltd
Conditions:
Critical Illness
Intensive Care
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
Protocol No. AP2006-01 Study title: A Prospective, Open, Randomised, Multicentre, Controlled Group Study to Assess the Safety and Efficacy of Navigator versus Conventional Care in Postoperative Cardi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00468247
Start Date
March 1 2007
End Date
April 1 2008
Last Update
April 25 2008
Active Locations (7)
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1
St Vincent's Public Hospital
Sydney, New South Wales, Australia, 2010
2
Royal North Shore Hospital
Sydney, New South Wales, Australia, 2065
3
Westmead Private Hospital
Sydney, New South Wales, Australia, 2145
4
Westmead Public Hospital
Sydney, New South Wales, Australia, 2145