NCT00468247

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

April 25, 2008

Status Verified

April 1, 2008

Enrollment Period

1.1 years

First QC Date

April 30, 2007

Last Update Submit

April 24, 2008

Conditions

Critical IllnessIntensive Care

Keywords

mean systemic pressurefluid therapyclosed loop controlcirculation modelling

Outcome Measures

Primary Outcomes (1)

  • Average distance to central point of the target cardiovascular zone while connected to the device

    Time connected to Navigator device

Secondary Outcomes (4)

  • Percentage time in the target cardiovascular zone while connected to device

    Time connected to Navigator device

  • Clinically significant AF while connected to device

    Time connected to Navigator device

  • Multiple organ function (SOFA score)

    From connection to Navigator device to hospital discharge

  • Device-related adverse events and device failures

    Time connected to Navigator device

Study Arms (2)

1

ACTIVE COMPARATOR

Device , Navigator used for guiding haemodynamic care

Device: Navigator

2

PLACEBO COMPARATOR

Conventional care

Other: Conventional care

Interventions

NavigatorDEVICE

Navigator circulatory mgt system

1
Conventional careOTHER

Conventional haemodynamic care

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

St Vincent's Public Hospital

Sydney, New South Wales, 2010, Australia

Location

Royal North Shore Hospital

Sydney, New South Wales, 2065, Australia

Location

Westmead Private Hospital

Sydney, New South Wales, 2145, Australia

Location

Westmead Public Hospital

Sydney, New South Wales, 2145, Australia

Location

St George Public Hospital

Sydney, New South Wales, 2217, Australia

Location

Monash Medical Centre

Melbourne, Victoria, 3168, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3181, Australia

Location

Related Publications (2)

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

    PMID: 16603021BACKGROUND

  • 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. doi: 10.1177/0310057X1103900207.

    PMID: 21485666DERIVED

Related Links

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yugan Mudaliar, PhD

    Western Sydney Area Health Service

    PRINCIPAL INVESTIGATOR

  • Geoff Parkin, PhD

    Monash Medical Centre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 30, 2007

First Posted

May 2, 2007

Study Start

March 1, 2007

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

April 25, 2008

Record last verified: 2008-04

Locations

AU(7)