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Trial registered on ANZCTR


Registration number
ACTRN12615000130561
Ethics application status
Approved
Date submitted
30/01/2015
Date registered
12/02/2015
Date last updated
6/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Monitoring of the fluid status of critically ill patients by bio-impedance vector analysis (BIVA): A before-and-after study
Scientific title
The use of bio-impedance vector analysis in the measurement of body water index in critically ill patients admitted to the intensive care unit: A before-and-after study
Secondary ID [1] 286080 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Bio-Impendence Vector Analysis (BIVA) fluid status monitoring
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 294079 0
Condition category
Condition code
Other 294383 294383 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Twice daily bio-impedance vector analysis monitoring commencing within the first 24 hours of admission in adult (aged 18 years or older) mechanically ventilated adult patients admitted to the intensive care unit.

In the after period the patient's treating clinical care team will be informed of the finding of the assessment.

For both patients both in the before and in the after period all other clinical decisions will be made as per the patient's treating clinical team.
Intervention code [1] 291073 0
Other interventions
Comparator / control treatment
Twice daily bio-impedance vector analysis monitoring in adult (aged 18 years or older) mechanically ventilated adult patients admitted to the intensive care unit. Measurements are made by placing two small adhesive electrodes stickers, one near the wrist and onear the ankle of the same side of the body. The device then sends a low voltage electric current down one wire and receives the impulse back via the other. The impedance to the electric current determines the measurement output. The duration of the measurement is less than 20 seconds.

In the before period the patient's treating clinical care team will be blinded to the finding of the assessment. During this period the assessments are commenced within the first 24 hours of the patient's admission to the intensive care unit.

For both patients both in the before and in the after period all other clinical decisions will be made as per the patient's treating clinical team.
Control group
Active

Outcomes
Primary outcome [1] 294173 0
Mean daily fluid balance as per the routine recording of input and output by the intensive care clinical staff for each patient.
Timepoint [1] 294173 0
Daily from admission to ICU through to the patient's discharge from the ICU
Primary outcome [2] 294174 0
Bio-impedance vector analysis measurement of body water index
Timepoint [2] 294174 0
Change in the twice daily bio-impedance vector analysis measurement for enrolment into the study within the first 24 hours of ICU admission until the patient's discharge from the ICU.
Secondary outcome [1] 312683 0
Length of stay - intensive care
Timepoint [1] 312683 0
Daily from admission to ICU until ICU discharge
Secondary outcome [2] 312684 0
Length in stay - hospital
Timepoint [2] 312684 0
Daily from admission to hospital until discharge from hospital
Secondary outcome [3] 312685 0
Serum creatinine
Timepoint [3] 312685 0
Daily changes in the patient's serum creatinine from the date the patient is admitted to the ICU until the date at which they are discharged from the ICU
Secondary outcome [4] 312686 0
Arterial oxygen tension to fraction of inspired oxygen ratio (PaO2/FiO2 ratio) as obtained from routine arterial blood gas analysis
Timepoint [4] 312686 0
Daily from admission to ICU until ICU discharge
Secondary outcome [5] 312687 0
Vasopressor requirement as determined by reviewing the patient's medical record
Timepoint [5] 312687 0
Daily from ICU admission until ICU discharge
Secondary outcome [6] 312688 0
Serum lactate
Timepoint [6] 312688 0
Daily changes in the patient's serum lactate by reviewing the patient's medical record for the duration of the patient's admission to the intensive care unit
Secondary outcome [7] 312689 0
Mechanical ventilation assessed via review of the patient's medical record
Timepoint [7] 312689 0
Duration in hours that the patient requires mechancial ventilation assessed daily from admission to ICU until ICU discharge
Secondary outcome [8] 312690 0
Continuous renal replacement therapy assessed via review of the patient's medical record
Timepoint [8] 312690 0
Need for continuous renal replacement therapy assessed daily from admission to ICU until ICU discharge
Secondary outcome [9] 312691 0
Mortality - intensive care unit
Timepoint [9] 312691 0
Incidence of death occuring in the intensive care unit
Secondary outcome [10] 312692 0
Mortality - hospital
Timepoint [10] 312692 0
Incidence of death occuring in the hospital

Eligibility
Key inclusion criteria
1. Adult (aged 18 years or older) admitted to the intensive care unit
2. Currently receiving mechanical ventilation
3. Expected to stay in the intensive care unit until the day after tomorrow
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The following patients will be excluded from the trial
1. Patients on chronic dialysis
2. Patients admitted after cardiac surgery
3. Patients with a pacemaker
4. Patients with an implantable defibrillator
5. Pregnant patients
6. Patients with diaphragmatic pacing

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Descriptive and inferential statistical procedures will be used together with analysis of variance to assess for changes over time. For this pilot study we feel that greater than 200 measurements in more than 60 patients in both the before period and in the after period will provide a meaningful interpretation of the value of bio-impedance vector analysis for the measurement of body water index for patients admitted to the intensive care unit.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
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 in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3380 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 9165 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 290665 0
Hospital
Name [1] 290665 0
Austin Hospital
Address [1] 290665 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelbrg VIC 3084
Country [1] 290665 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Austin Health
145 Studley Road
Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 289358 0
Individual
Name [1] 289358 0
Professor Rinaldo Bellomo
Address [1] 289358 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelbrg VIC 3084
Country [1] 289358 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292294 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 292294 0
Austin Health
145 Studley Road
Heidelbrg VIC 3084
Ethics committee country [1] 292294 0
Australia
Date submitted for ethics approval [1] 292294 0
27/11/2012
Approval date [1] 292294 0
24/04/2013
Ethics approval number [1] 292294 0
H2012/04864

Summary
Brief summary
The monitoring of fluid status in critically ill patients is challenging. Fluid balance is often incorrect and does not take into account insensible fluid losses, which in febrile patients can add up to a litre or more/day. Weighing with beds equipped with electronic scales has been shown to be unreliable and inaccurate in ICU patients. Intravascular filling pressures are not reliably related to extravascular fluid accumulation. Oedema can only be detected once up to 4-5 litres of excess fluid have accumulated. These shortcomings in fluid assessment are particularly problematic in patients who stay in ICU for a longer period of time, where daily errors in assessment accrue to make estimates of fluid status particularly inaccurate. These technical problems are potentially clinically significance as fluid accumulation has been repeatedly identified as an independent risk factor for mortality in ICU patients.
The development of novel bio-impedance vector analysis (BIVA) has recently been shown to provide a reliable, reproducible, robust, safe, and non-invasive assessment of hydration which can be performed at the bedside of critically ill patients by evaluating the bioelectrical impedance of the human body. This approach uses the administration of alternating (AC) microcurrents (microamperes) a low frequency (50kHz) with a standard four-electrode system. Such microcurrents are well below the sensation threshold for human beings.
The resistance (R) and reactance (Xc) adjusted for height of the whole body provide information on the ability of the microcurrent to move from ankle electrodes and reach sensor wrist electrode. The relationship between resistance (dependent of body fluid volume) and reactance (dependent on the capacitance of membranes and tissue interfaces) allows the construction of a vector on an X-Y plot.

This vector can be related to vectors obtained from >18,000 normal subjects which have been used to define reference values. These values identify states of low resistance and low reactance (fluid overload). Such individual vectors can then also be used to monitor changes in the fluid status of an individual. This approach has been applied to identify fluid overload in dialysis patients, cardiac failure patients, and, in pilot work, in critically ill patients.

In this study, we propose to compare fluid management in mechanically ventilated patients expected to stay in ICU until the day after tomorrow treated with standard care during a period when clinicians are not informed of the bio-impedance measurement followed by a period in which they are informed of the measurement.
Trial website
Trial related presentations / publications
Bioelectrical impedance vector analysis in critically ill patients: a prospective, clinician-blinded investigation.
Jones SL, Tanaka A, Eastwood GM, Young H, Peck L, Bellomo R, Martensson J.
Crit Care. 2015 Aug 12;19:290. doi: 10.1186/s13054-015-1009-3.
Public notes

Contacts
Principal investigator
Name 54526 0
Prof Rinaldo Bellomo
Address 54526 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg Vic 3084
Country 54526 0
Australia
Phone 54526 0
+61 3 9496 5992
Fax 54526 0
+61 3 9496 3932
Email 54526 0
rinaldo.bellomo@austin.org.au
Contact person for public queries
Name 54527 0
A/Prof Glenn Eastwood
Address 54527 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg Vic 3084
Country 54527 0
Australia
Phone 54527 0
+61 3 9496 4835
Fax 54527 0
+61 3 9496 3932
Email 54527 0
glenn.eastwood@austin.org.au
Contact person for scientific queries
Name 54528 0
Prof Rinaldo Bellomo
Address 54528 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg Vic 3084
Country 54528 0
Australia
Phone 54528 0
+61 3 9496 5992
Fax 54528 0
+61 3 9496 3932
Email 54528 0
rinaldo.bellomo@austin.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary