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Trial registered on ANZCTR


Registration number
ACTRN12611001197921
Ethics application status
Approved
Date submitted
18/11/2011
Date registered
21/11/2011
Date last updated
12/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Computerised Assistance of Cardiovascular Monitoring in Intensive Care
Scientific title
Retrospective, proof of concept study on model-based cardiovascular monitoring in critical care for improved diagnosis of circulatory dysfunction
Secondary ID [1] 273403 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular dysfunction 279182 0
Condition category
Condition code
Cardiovascular 279378 279378 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 279379 279379 0 0
Coronary heart disease
Cardiovascular 279380 279380 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A series of short therapeutic interventions will be performed on study patients following a pre-defined protocol:

1. A thermo-dilution will be performed at the start of each study to assess cardiac output and correctly reflect the patient’s volume status.

2. Optimizing ventilator settings by adjusting the PEEP level will help quantify fluid responsiveness. PEEP will be varied +/-5 cmH2O from the clinically-determined setting. The changes in CVS responses will be recorded.

3. Patients are often given infusions of adrenaline and/or noradrenaline (heart stimulants) which are titrated to a clinical response. No formal protocols exist to guide clinicians. This treatment is largely carried our using intuition and experience. The clinically-determined inotrope dose will be changed +/- 20% with increments of 1 mcg/min every 5 minutes. At each change in dose, the CVS responses will be recorded. The reason for this exercise is to assess the patients sensitivity to the drugs they are receiving. The maximal change in noradrenaline or adrenaline will be limited to 5 mcg/min. For example a patient receiving an infusion of noradrenaline at 10 mcg/min will have their infusion changed to 8,9,10,11,12 mcg/min for up to 5 minutes at each setting. After this the patients infusion will be returned to starting rate (10 mcg/min) or as clinically indicated.
Intervention code [1] 283737 0
Other interventions
Intervention code [2] 283754 0
Early detection / Screening
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 285977 0
To assess the ability of the model-based method to retrospectively track hemodynamic changes resulting from the inotropic and PEEP interventions. The model-based results will be compared to clinical diagnoses, clinically derived CVS performance metrics, and standard ICU hemodynamic measurements. Where applicable, the ability of the model to capture the data will be analysed by 90% confidence intervals of the absolute percentage error between the identified model predictions and the measured response. Errors within measurement error of 10% will be assumed to be a fully accurate prediction.
Timepoint [1] 285977 0
The outcomes of the trials will be assessed at the end of the clinical study.
Secondary outcome [1] 294880 0
To store all the hemodynamic measurements recorded in the ICU including: arterial pressure, central venous pressure, pulmonary artery pressure, stroke volume, global end diastolic volume, extra-vascular lung water, heart rate, respiratory pressure and flow, ECG, and other available cardiac and circulatory measurements to create a virtual patient database for future research.
Timepoint [1] 294880 0
The database will be set up at the end of the study.

Eligibility
Key inclusion criteria
Post-cardiac surgery or diagnosed CVS dysfunction as leading contributor to ICU admission; Arterial and central venous catheterization; and full or intermittent mechanical ventilation (intubated).
Minimum age
16 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Moribund or not expected to survive 48 hours; patient not intubated or does not have required catheters for measurements.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3955 0
New Zealand
State/province [1] 3955 0

Funding & Sponsors
Funding source category [1] 284224 0
University
Name [1] 284224 0
University of Canterbury
Address [1] 284224 0
22 Kirkwood Avenue
Riccarton
8041
Private Bag 4800
Country [1] 284224 0
New Zealand
Funding source category [2] 284225 0
Hospital
Name [2] 284225 0
Christchurch Hospital
Address [2] 284225 0
Riccarton Avenue
Private Bag 4710
Christchurch 8140
Country [2] 284225 0
New Zealand
Primary sponsor type
University
Name
University of Canterbury
Address
22 Kirkwood Avenue
Riccarton
8041
Private Bag 4800
Country
New Zealand
Secondary sponsor category [1] 269180 0
Hospital
Name [1] 269180 0
Christchurch Hospital
Address [1] 269180 0
Riccarton Avenue
Private Bag 4710
Christchurch 8140
Country [1] 269180 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286187 0
Multi-region Ethics Committee
Ethics committee address [1] 286187 0
Ministry of Health
133 Molesworth Street,
PO Box 5013
Wellington 6145
Ethics committee country [1] 286187 0
New Zealand
Date submitted for ethics approval [1] 286187 0
10/02/2010
Approval date [1] 286187 0
24/02/2010
Ethics approval number [1] 286187 0
MEC/09/12/144

Summary
Brief summary
Currently, cardiac assessment of critical care patients involves the analysis of changes in aortic pressure, cardiac output, central venous pressure, heart rate, ECG and gas exchange measurements relative to a normal or “average” patient. However, complex interactions in these measurements can hide the underlying disease state so that clinicians receive no clear picture of overall circulatory status or function. This research proposes to use a computer model of the CVS to aggregate the clinical data into a more readily understood physiological context for clinicians, by exposing hidden dynamics, and thus allowing a stronger foundation for treatment selection.
This study tests the ability of the CVS model to monitor and characterize cardiac disturbances in a critical care setting. During the observation period, the participants will receive interventions which are determined by clinical judgement and which follow standardized protocols. These interventions will involve administering fluids, medicines that increase blood pressure and stimulate the heart, and changing ventilator settings, which are known to impact on the circulation. Each participant’s CVS response will be recorded and all interventions will be consistent with normal clinical practice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33402 0
Address 33402 0
Country 33402 0
Phone 33402 0
Fax 33402 0
Email 33402 0
Contact person for public queries
Name 16649 0
Dr. Geoffrey Shaw
Address 16649 0
Department of Intensive Care
Christchurch Hospital
Riccarton Avenue
Private Bag 4710
Christchurch 8140
Country 16649 0
New Zealand
Phone 16649 0
+64 3 364 1077
Fax 16649 0
+64 3 364 0099
Email 16649 0
Geoff.Shaw@cdhb.govt.nz
Contact person for scientific queries
Name 7577 0
Dr. Geoffrey Shaw
Address 7577 0
Department of Intensive Care
Christchurch Hospital
Riccarton Avenue
Private Bag 4710
Christchurch 8140
Country 7577 0
New Zealand
Phone 7577 0
+64 3 364 1077
Fax 7577 0
+64 3 364 0099
Email 7577 0
Geoff.Shaw@cdhb.govt.nz

No data has been provided for results reporting
Summary results
Not applicable