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Registration Enabling Study of the Safety and Efficacy of the Use of the Navigator Circulatory Management System

NCT00468247 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2008-04-25

No results posted yet for this study

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 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.

Conditions

  • Critical Illness
  • Intensive Care

Interventions

DEVICE

Navigator

Navigator circulatory mgt system

OTHER

Conventional care

Conventional haemodynamic care

Sponsors & Collaborators

  • Trident Clinical Research Pty Ltd

    collaborator INDUSTRY

  • Applied Physiology Pty Ltd

    lead OTHER

Principal Investigators

  • Yugan Mudaliar, PhD · Western Sydney Area Health Service

  • Geoff Parkin, PhD · Monash Medical Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00468247 on ClinicalTrials.gov