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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
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Scientific title
The use of bedside ultrasonography to detect pulmonary congestion in haemodialysis patients - a feasibility study
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Secondary ID [1]
290639
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None
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Universal Trial Number (UTN)
U1111-1190-4600
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Fluid overload in haemodialysis patients
301161
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Determining target weight in haemodialysis patients
301162
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Haemodynamic stability on haemodialysis
301163
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Condition category
Condition code
Renal and Urogenital
300926
300926
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0
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Kidney disease
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Cardiovascular
300927
300927
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
296524
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Diagnosis / Prognosis
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
300342
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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.
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Assessment method [1]
300342
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Timepoint [1]
300342
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End of the trial
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Primary outcome [2]
300343
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Acceptability of the procedure to the patient on a scale of 1 to 5
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Assessment method [2]
300343
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Timepoint [2]
300343
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End of the procedure
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Primary outcome [3]
300345
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Acceptability of the procedure to the novice operators on a scale of 1 to 5
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Assessment method [3]
300345
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Timepoint [3]
300345
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End of the trial
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Secondary outcome [1]
329738
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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
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Assessment method [1]
329738
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Timepoint [1]
329738
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end of the trial
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Secondary outcome [2]
329741
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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.
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Assessment method [2]
329741
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Timepoint [2]
329741
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End of the trial
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Any one not meeting the inclusion criteria
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
Cross-sectional before and after trial
The scans recorded will be blindly interpreted by the study radiologist
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
3/04/2017
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Actual
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Date of last participant enrolment
Anticipated
5/06/2017
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Actual
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Date of last data collection
Anticipated
3/07/2017
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
7006
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Gold Coast University Hospital - Southport
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Recruitment postcode(s) [1]
14738
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4215 - Southport
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Funding & Sponsors
Funding source category [1]
295075
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Hospital
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Name [1]
295075
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Gold Coast University Hospital
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Address [1]
295075
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1 Hospital Boulevard
Southport 4215
Queensland
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Country [1]
295075
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Australia
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Primary sponsor type
Hospital
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Name
Gold Coast University Hospital
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Address
1 Hospital Boulevard
Southport 4215
Queensland
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Country
Australia
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Secondary sponsor category [1]
293887
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None
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Name [1]
293887
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None
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Address [1]
293887
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None
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Country [1]
293887
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
296427
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Gold Coast Hospital and Health Service HREC
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Ethics committee address [1]
296427
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1 Hospital Boulevard Southport 4215 Queensland
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Ethics committee country [1]
296427
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Australia
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Date submitted for ethics approval [1]
296427
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06/03/2017
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Approval date [1]
296427
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Ethics approval number [1]
296427
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
70818
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Dr Balaji Hiremagalur
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Address
70818
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Gold Coast Hospital and Health Services
1 Hospital Boulevard
Southport 4215
Queensland
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Country
70818
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Australia
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Phone
70818
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+61 7 5687 4206
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Fax
70818
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Email
70818
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[email protected]
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Contact person for public queries
Name
70819
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Balaji Hiremagalur
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Address
70819
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Gold Coast Hospital and Health Services
1 Hospital Boulevard
Southport 4215
Queensland
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Country
70819
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Australia
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Phone
70819
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+61 7 5687 4206
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Fax
70819
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Email
70819
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[email protected]
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Contact person for scientific queries
Name
70820
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Balaji Hiremagalur
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Address
70820
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Gold Coast Hospital and Health Services
1 Hospital Boulevard
Southport 4215
Queensland
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Country
70820
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Australia
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Phone
70820
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+61 7 5687 4206
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Fax
70820
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Email
70820
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[email protected]
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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.
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