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Trial registered on ANZCTR


Registration number
ACTRN12616001663448p
Ethics application status
Not yet submitted
Date submitted
29/11/2016
Date registered
2/12/2016
Date last updated
2/12/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Bedside ultrasound to detect excess lung water in haemodialysis patients
Scientific title
The use of bedside ultrasonography to detect pulmonary congestion in haemodialysis patients - a feasibility study
Secondary ID [1] 290639 0
None
Universal Trial Number (UTN)
U1111-1190-4600
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fluid overload in haemodialysis patients 301161 0
Determining target weight in haemodialysis patients 301162 0
Haemodynamic stability on haemodialysis 301163 0
Condition category
Condition code
Renal and Urogenital 300926 300926 0 0
Kidney disease
Cardiovascular 300927 300927 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Lung ultrasound will be performed by novice operators after training and assessment for competence. Novice operators - 2 renal specialists, 2 renal trainees and 2 dialysis nurses with no formal radiology training will be recruited through expression of interest.

The training will involve attending a half-day workshop conducted by Australian Ultrasound Institute and completing a quiz. After this they need to report and submit prescribed number of unsupervised scans recorded as 3-s cine loop for assessment by the study radiologist. They will participate in the research only after being deemed competent by the study radiologist.

Each participant receives one lung ultrasound scan immediately prior to haemodialysis and a repeat scan immediately post haemodialysis on a single occasion only.

Scan of each zone is saved as de-identified 3-s cine loop.

All the recorded scans will be blindly reported by the study radiologist.
Intervention code [1] 296524 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300342 0
The expert operator - study radiologist, will be presented all the individual zone scans (480) recorded for blind interpretation. It will also be presented to the six novice operators (a minimum of one month after the last scan) for blind interpretation. The concordance between the expert and each of the raters, and whether any type of raters (eg specialist/trainees/nurses) have better concordance with expert ratings will be investigated.
Timepoint [1] 300342 0
End of the trial
Primary outcome [2] 300343 0
Acceptability of the procedure to the patient on a scale of 1 to 5
Timepoint [2] 300343 0
End of the procedure
Primary outcome [3] 300345 0
Acceptability of the procedure to the novice operators on a scale of 1 to 5
Timepoint [3] 300345 0
End of the trial
Secondary outcome [1] 329738 0
Proportion of positive lung scans post-haemodialysis

The lung scan is positive when there are 3 or more B lines are detected in two or more zones on one side of the lung, and in one or more zones on the contra-lateral side. A B line has five mandatory features:
- it arises from pleural line
- it is well defined (laser-beam-like)
- spreads to the edge of the screen without fading
- erases A lines
- moves with lung sliding
Timepoint [1] 329738 0
end of the trial
Secondary outcome [2] 329741 0
Correlation between weight loss on dialysis in kg (difference between pre- and post-dialysis weight) and the change in extent of lung water (overall result of the scan) pre- to post-dialysis will be evaluated.
Timepoint [2] 329741 0
End of the trial

Eligibility
Key inclusion criteria
1. On haemodialysis three times a week
2. 18 years or over
3. Ability to consent
4. Have a set target weight
5. Outpatient
6. No clinical evidence of lower respiratory tract infection
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any one not meeting the inclusion criteria

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Cross-sectional before and after trial
The scans recorded will be blindly interpreted by the study radiologist
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
1. Appropriate descriptive statistics
2. We will calculate the concordance between the expert and each of the raters, and investigate whether any type of raters (eg specialist/trainees/nurses) have better concordance with expert ratings using mixed-effects logistic regression, with type of rater included as a main effect and individual included as a random intercept, in order to account for multiple observations from the same rater.
3. The magnitude and significance of association between the weight loss and change in the extent of lung water following dialysis will be investigated using linear regression with weight loss as the main effect and change in lung water as the main effect.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/04/2017
Actual
Date of last participant enrolment
Anticipated
5/06/2017
Actual
Date of last data collection
Anticipated
3/07/2017
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7006 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 14738 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 295075 0
Hospital
Name [1] 295075 0
Gold Coast University Hospital
Country [1] 295075 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast University Hospital
Address
1 Hospital Boulevard
Southport 4215
Queensland
Country
Australia
Secondary sponsor category [1] 293887 0
None
Name [1] 293887 0
None
Address [1] 293887 0
None
Country [1] 293887 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 296427 0
Gold Coast Hospital and Health Service HREC
Ethics committee address [1] 296427 0
1 Hospital Boulevard
Southport 4215
Queensland
Ethics committee country [1] 296427 0
Australia
Date submitted for ethics approval [1] 296427 0
06/03/2017
Approval date [1] 296427 0
Ethics approval number [1] 296427 0

Summary
Brief summary
Patients on dialysis lack the ability to excrete water adequately and accumulate water in-between dialysis sessions. This excess fluid accumulated needs removal on dialysis. Traditionally the amount of excess fluid accumulated by the patient is estimated by clinical examination. Whilst large fluid excess (volume overload) is relatively easy to detect on clinical examination, it is unreliable for detecting subtle fluid excess. Underestimation of the amount of fluid to be removed on dialysis leads to long term volume overload that results in a number of detrimental effects such as high blood pressure, heart failure and
other disorders of the heart and blood vessels that eventually lead to increased mortality. Overestimation of the amount of fluid that needs to be removed on dialysis, results in volume deficit causing post-dialysis fatigue, low blood pressure, dizziness, cramps, seizure and dialysis interruptions that can result in under dialysis.

The use of objective measures to supplement the clinical assessment of volume status in dialysis patients is gaining attention. Some of the techniques used have focused on measuring inferior vena cava diameter, bioimpedance and circulating blood volume. These techniques do not convey information on heart function that is critical to patients’ tolerance and response to fluid removal on dialysis. The measure of lung water, the accumulation of which reflects both heart function and the circulating blood volume appear to be much better at identifying patients at risk of adverse volume dependent clinical outcomes
and to monitor effects of fluid removal aimed at preventing these adverse outcomes. Recently a quick, simple and easy to learn measure of lung water using ultrasonography has been validated in dialysis patients.

The current study aims to assess the feasibility of introducing routine assessment, by the renal unit staff, of volume status in our dialysis patients by measuring their lung water using bedside ultrasonography. We will evaluate the acceptability of the procedure to the operators and patients along with the inter-observer variability. The sensitivity of the ultrasound changes to changes in body weight following dialysis, and the proportion of patients with lung water post-haemodialysis will also be assessed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70818 0
Dr Balaji Hiremagalur
Address 70818 0
Gold Coast Hospital and Health Services
1 Hospital Boulevard
Southport 4215
Queensland
Country 70818 0
Australia
Phone 70818 0
+61 7 5687 4206
Fax 70818 0
Email 70818 0
[email protected]
Contact person for public queries
Name 70819 0
Balaji Hiremagalur
Address 70819 0
Gold Coast Hospital and Health Services
1 Hospital Boulevard
Southport 4215
Queensland
Country 70819 0
Australia
Phone 70819 0
+61 7 5687 4206
Fax 70819 0
Email 70819 0
[email protected]
Contact person for scientific queries
Name 70820 0
Balaji Hiremagalur
Address 70820 0
Gold Coast Hospital and Health Services
1 Hospital Boulevard
Southport 4215
Queensland
Country 70820 0
Australia
Phone 70820 0
+61 7 5687 4206
Fax 70820 0
Email 70820 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

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