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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]

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

Condition category

Condition code

Other

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]

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]

Mean daily fluid balance as per the routine recording of input and output by the intensive care clinical staff for each patient.

Timepoint [1]

Daily from admission to ICU through to the patient's discharge from the ICU

Primary outcome [2]

Bio-impedance vector analysis measurement of body water index

Timepoint [2]

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]

Length of stay - intensive care

Timepoint [1]

Daily from admission to ICU until ICU discharge

Secondary outcome [2]

Length in stay - hospital

Timepoint [2]

Daily from admission to hospital until discharge from hospital

Secondary outcome [3]

Serum creatinine

Timepoint [3]

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]

Arterial oxygen tension to fraction of inspired oxygen ratio (PaO2/FiO2 ratio) as obtained from routine arterial blood gas analysis

Timepoint [4]

Daily from admission to ICU until ICU discharge

Secondary outcome [5]

Vasopressor requirement as determined by reviewing the patient's medical record

Timepoint [5]

Daily from ICU admission until ICU discharge

Secondary outcome [6]

Serum lactate

Timepoint [6]

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]

Mechanical ventilation assessed via review of the patient's medical record

Timepoint [7]

Duration in hours that the patient requires mechancial ventilation assessed daily from admission to ICU until ICU discharge

Secondary outcome [8]

Continuous renal replacement therapy assessed via review of the patient's medical record

Timepoint [8]

Need for continuous renal replacement therapy assessed daily from admission to ICU until ICU discharge

Secondary outcome [9]

Mortality - intensive care unit

Timepoint [9]

Incidence of death occuring in the intensive care unit

Secondary outcome [10]

Mortality - hospital

Timepoint [10]

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

Sex

Both males and females

Can healthy volunteers participate?

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

2/08/2014

Actual

2/08/2014

Date of last participant enrolment

Anticipated

Actual

20/02/2015

Date of last data collection

Anticipated

Actual

1/06/2015

Sample size

Target

150

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Austin Health - Austin Hospital - Heidelberg

Recruitment postcode(s) [1]

3084 - Heidelberg

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Austin Hospital

Address [1]

Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelbrg VIC 3084

Country [1]

Australia

Primary sponsor type

Hospital

Name

Austin Health

Address

Austin Health
145 Studley Road
Heidelberg VIC 3084

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Professor Rinaldo Bellomo

Address [1]

Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelbrg VIC 3084

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Research Ethics Committee

Ethics committee address [1]

Austin Health
145 Studley Road
Heidelbrg VIC 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/11/2012

Approval date [1]

24/04/2013

Ethics approval number [1]

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

Attachments [1]

/AnzctrAttachments/367867-04864 Approval of LNRR amendment (May 13).pdf

Contacts

Principal investigator

Name

Prof Rinaldo Bellomo

Address

Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg Vic 3084

Country

Australia

Phone

+61 3 9496 5992

Fax

+61 3 9496 3932

[email protected]

Contact person for public queries

Name

Glenn Eastwood

Address

Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg Vic 3084

Country

Australia

Phone

+61 3 9496 4835

Fax

+61 3 9496 3932

[email protected]

Contact person for scientific queries

Name

Rinaldo Bellomo

Address

Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg Vic 3084

Country

Australia

Phone

+61 3 9496 5992

Fax

+61 3 9496 3932

[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

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No additional documents have been identified.

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