ANZCTR - Registration

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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]

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

Determining target weight in haemodialysis patients

Haemodynamic stability on haemodialysis

Condition category

Condition code

Renal and Urogenital

Kidney disease

Cardiovascular

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]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

End of the trial

Primary outcome [2]

Acceptability of the procedure to the patient on a scale of 1 to 5

Timepoint [2]

End of the procedure

Primary outcome [3]

Acceptability of the procedure to the novice operators on a scale of 1 to 5

Timepoint [3]

End of the trial

Secondary outcome [1]

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]

end of the trial

Secondary outcome [2]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Gold Coast University Hospital - Southport

Recruitment postcode(s) [1]

4215 - Southport

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Gold Coast University Hospital

Address [1]

1 Hospital Boulevard
Southport 4215
Queensland

Country [1]

Australia

Primary sponsor type

Hospital

Name

Gold Coast University Hospital

Address

1 Hospital Boulevard
Southport 4215
Queensland

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Gold Coast Hospital and Health Service HREC

Ethics committee address [1]

1 Hospital Boulevard
Southport 4215
Queensland

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

06/03/2017

Approval date [1]

Ethics approval number [1]

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

Dr Balaji Hiremagalur

Address

Gold Coast Hospital and Health Services
1 Hospital Boulevard
Southport 4215
Queensland

Country

Australia

Phone

+61 7 5687 4206

Fax

Balaji.Hiremagalur@health.qld.gov.au

Contact person for public queries

Name

Balaji Hiremagalur

Address

Gold Coast Hospital and Health Services
1 Hospital Boulevard
Southport 4215
Queensland

Country

Australia

Phone

+61 7 5687 4206

Fax

Balaji.Hiremagalur@health.qld.gov.au

Contact person for scientific queries

Name

Balaji Hiremagalur

Address

Gold Coast Hospital and Health Services
1 Hospital Boulevard
Southport 4215
Queensland

Country

Australia

Phone

+61 7 5687 4206

Fax

Balaji.Hiremagalur@health.qld.gov.au

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 documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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