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Trial registered on ANZCTR


Registration number
ACTRN12608000486325
Ethics application status
Approved
Date submitted
18/08/2008
Date registered
30/09/2008
Date last updated
13/07/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of non-invasive cardiac output monitoring in the emergency room:
Scientific title
A randomised controlled trial of non-invasive cardiac output monitoring on oxygen delivery in critically ill emergency department patients.
Secondary ID [1] 727 0
Nil
Universal Trial Number (UTN)
Trial acronym
The NICER TRial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness in the emergency department requiring urgent administration of at least 500ml intravenous fluid 3574 0
Condition category
Condition code
Cardiovascular 3733 3733 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will be allocated to standard care plus non-invasive cardiac output monitoring (intervention).
Non-invasive cardiac output monitoring for four hours in the Emergency Department (ED).
Intervention code [1] 3288 0
Early detection / Screening
Comparator / control treatment
Standard care for the presenting illness without cardiac output monitoring.
Control group
Active

Outcomes
Primary outcome [1] 4831 0
Lactate levels as measured by blood gas analysis
Timepoint [1] 4831 0
Four hours post enrollment
Primary outcome [2] 4832 0
Base excess as measured by blood gas analysis
Timepoint [2] 4832 0
Four hours post enrollment
Primary outcome [3] 4833 0
Vital signs (heart rate and blood pressure)
Timepoint [3] 4833 0
Four hours post enrollment
Secondary outcome [1] 7829 0
Questionnaire regarding clinicians management plans for each patient, before and after cardiac output monitoring.
Timepoint [1] 7829 0
Four hours post enrollment

Eligibility
Key inclusion criteria
Critically ill adults in the ED requiring referral to Intensive Care for consideration of admission.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age < 18

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients requiring urgent fluid administration will be randomised to having this guided by non-invasive cardiac output monitoring where stroke volume variation will be used to guide resuscitation or to standard care
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation will be by computerized random number generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
222
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3750 0
Government body
Name [1] 3750 0
Queensland Emergency Medicine Research Foundation
Country [1] 3750 0
Australia
Primary sponsor type
Individual
Name
Ogilvie Thom
Address
Box Hill Hospital
Nelson Road
Box Hill
Vic 3128
Country
Australia
Secondary sponsor category [1] 3363 0
None
Name [1] 3363 0
Address [1] 3363 0
Country [1] 3363 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5807 0
Human research Ethics Committee
The Prince Charles Hospital
Ethics committee address [1] 5807 0
Rode Road, Chermside, QLD 4032
Ethics committee country [1] 5807 0
Australia
Date submitted for ethics approval [1] 5807 0
17/03/2010
Approval date [1] 5807 0
Ethics approval number [1] 5807 0
HREC/10/QPCH/16

Summary
Brief summary
Critically ill patients often have signs of inadequate oxygen delivery. We know this adversely impacts on survival. The hypothesis is that the introduction of non invasive cardiac output monitoring will allow us to improve or correct oxygen delivery, thus possibly improving survival
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28857 0
Address 28857 0
Country 28857 0
Phone 28857 0
Fax 28857 0
Email 28857 0
Contact person for public queries
Name 12014 0
Dr Ogilvie Thom
Address 12014 0
Emergency Department, Princess Alexandra Hospital, Ipswich road, Wolloongabba, QLD
Country 12014 0
Australia
Phone 12014 0
(03) 9895 3333
Fax 12014 0
Email 12014 0
[email protected]
Contact person for scientific queries
Name 2942 0
Dr Ogilvie Thom
Address 2942 0
Emergency Department, Princess Alexandra Hospital, Ipswich road, Wolloongabba, QLD
Country 2942 0
Australia
Phone 2942 0
(03) 9895 3333
Fax 2942 0
Email 2942 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.