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Trial registered on ANZCTR


Registration number
ACTRN12616000524493
Ethics application status
Approved
Date submitted
18/04/2016
Date registered
22/04/2016
Date last updated
13/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of pneumatic compression devices on intradialytic hypotension
Scientific title
The effect of pneumatic compression devices on intradialytic hypotension in chronic hemodialysis patients
Secondary ID [1] 288994 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intradialytic hypotension 298400 0
Condition category
Condition code
Renal and Urogenital 298498 298498 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention in this study is pneumatic compression device (PCD). The intervention period is 3 weeks for each participant. PCD will be applied every dialysis session (3 times a week) for 3 weeks during the intervention period for each participant.

Pneumatic compression devices (PCD) are widely used in prevention of thromboembolism in hospital settings and are generally well tolerated. During the sessions with pneumatic compression devices, the compression sleeve will be applied to participants’ legs. A pump will perform intermittent compression during the duration of your dialysis. Each cycle of compression last 60 seconds. The compression sleeve comprised of 3 chambers. The lowest chamber, middle chamber and highest chamber have pressure of 45mmHg, 40mmHg and 30mmHg respectively. The PCD has a venous refill detection system, which allows the controller to customize the compression cycles based upon the patient's individual venous refill time. The time between compression is between 20 and 60 seconds and will be automatically determined by the PCD.

During the study, dialysis nurses will apply PCD prior to commencing each dialysis and remove at the end of each dialysis during intervention period. Dialysis nurses will be trained by the manufacturing company regarding application of PCD and maintenance. The use of PCD will be recorded by dialysis nurse in the data collection record.

The location for this study will be at Frankston Hospital Hemodialysis Unit (Victoria, Australia).
Intervention code [1] 294481 0
Prevention
Intervention code [2] 294482 0
Treatment: Devices
Comparator / control treatment
Participants will be randomised into 2 groups, either to start with PCD or without PCD. Group A participants will have 3 weeks of dialysis with PCD, then one-week washout period of no intervention, followed by 3 weeks of dialysis without PCD. Group B participants will have 3 weeks of dialysis without PCD, followed by 3 weeks of dialysis with PCD.

During one-week washout period for group A participants, regular dialysis will continue to be administered as per usual care.

There are no differences for patients between treatment during washout period and three-week control treatment. Standard of care during dialysis will continue. However, during washout period, recorded parameters will not be used in the analysis of primary and secondary outcomes.
Control group
Active

Outcomes
Primary outcome [1] 297992 0
The primary outcome is intradialytic hypotension. We defined intradialytic hypotension as the presence of a decrease in blood pressure from pre-dialysis blood pressure of 20 mmHg or more at any time during dialysis. Blood pressure will be measured every hour during dialysis.

Timepoint [1] 297992 0
Dialysis parameters during intervention and non-intervention period will be recorded during the entire duration of the study (7 weeks). These parameters will be measured during every dialysis (three times a week) in the treatment period and non-treatment period.
Secondary outcome [1] 322852 0
First secondary outcome is symptomatic intradialytic hypotension which requires nursing intervention, which will be recorded in the medical record and data collection record. This will be reviewed and assessed by the investigators.

Timepoint [1] 322852 0
Blood pressure will be measured hourly during dialysis. Any hypotensive symptoms during dialysis requiring nursing intervention will be recorded. These will be recorded every dialysis session during the study.
Secondary outcome [2] 323064 0
Ability to achieve target weight post-dialysis.

Participants' weight will be measured using digital scales before and after each dialysis session being studied.
Timepoint [2] 323064 0
Weight prior and after dialysis will be measured during the duration of the study.
Secondary outcome [3] 323065 0
Postural hypotension at the end of hemodialysis – defined as a systolic blood pressure decrease of at least 20 mm Hg or a diastolic blood pressure decrease of at least 10 mm Hg within three minutes of standing.
Timepoint [3] 323065 0
Postural blood pressure (lying and standing) will be measured at the end of each dialysis session during the study.
Secondary outcome [4] 323066 0
Maximum fluid removal.

The amount of fluid removed each dialysis session will be obtained by review of dialysis records.
Timepoint [4] 323066 0
The amount of fluid removed will be recorded every dialysis session during the duration of the study.
Secondary outcome [5] 323067 0
Symptomatic intradialytic hypotension, assessed by recording any hypotensive symptoms during dialysis and measuring blood pressure using sphygmomanometer.
Timepoint [5] 323067 0
Blood pressure will be measured hourly during dialysis. Any hypotensive symptoms during dialysis will be recorded. These will be recorded every dialysis session during the study.
Secondary outcome [6] 323068 0
Nadir blood pressure < 100

This will be assessed by measuring blood pressure using sphygmomanometer.
Timepoint [6] 323068 0
Blood pressure will be measured hourly during dialysis. These will be recorded every dialysis session during the study.

Eligibility
Key inclusion criteria
Age greater than or equal to 18 years
Chronic hemodialysis 3 times a week for at least 3 months
Able to provide informed consent
Had intradialytic hypotension in at least 30% of hemodialysis sessions during the 4 weeks prior
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No recent hospital admission and no current active medical problems
Symptoms of critical lower limb ischemia
Pressure areas
Known current deep venous thrombosis or pulmonary embolism
Known active compartment syndrome
Vascular access dysfuncion
Inability to provide informed consent
Previous lower limb (s) amputation

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be determined by a computer-generated random number list, and concealed in envelopes to ensure allocation concealment.
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
Crossover
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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] 5620 0
Frankston Hospital - Frankston
Recruitment postcode(s) [1] 13067 0
3199 - Frankston

Funding & Sponsors
Funding source category [1] 293354 0
Commercial sector/Industry
Name [1] 293354 0
Covidien
Address [1] 293354 0
678 Victoria St
Richmond
Victoria
VIC 3121
Australia
Country [1] 293354 0
Australia
Primary sponsor type
Individual
Name
Dr. Kim Wong
Address
2 Hastings Road
Frankston
Victoria
VIC 3199
Australia
Country
Australia
Secondary sponsor category [1] 292180 0
None
Name [1] 292180 0
Address [1] 292180 0
Country [1] 292180 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294822 0
Peninsula Health Human Research and Ethics Committee
Ethics committee address [1] 294822 0
2 Hastings Road
Frankston
Victoria
VIC 3199
Australia
Ethics committee country [1] 294822 0
Australia
Date submitted for ethics approval [1] 294822 0
14/04/2016
Approval date [1] 294822 0
03/05/2016
Ethics approval number [1] 294822 0

Summary
Brief summary
Intradialytic hypotension (low blood pressure during dialysis) is a common problem in hemodialysis patients and can lead to poor outcomes. Pneumatic compression devices (PCD) are well established in the prevention of deep venous thrombosis and pulmonary embolism. It is thought that the use of PCDs during hemodialysis will increase venous return and improve hemodynamic stability. However, there is paucity in evidence regarding the use of PCDs during dialysis.

We aim to investigate the effect of PCDs on intradialytic hypotension, compared with standard of care. The study is a two-period, eighteen-treatment, randomized crossover trial. We aim to recruit between 16 and 25 patients from hemodialysis unit at Frankston Hospital.

Participants will be randomised into 2 groups, either to start with PCD or without PCD. Group A participants will have 3 weeks of dialysis with PCD, then one-week washout period of no intervention, followed by 3 weeks of dialysis without PCD. Group B participants will have 3 weeks of dialysis without PCD, followed by 3 weeks of dialysis with PCD. Standard of care during dialysis will remain the same during non-treatment period and washout period.

Primary outcome measured is intradialytic hypotension. Secondary outcomes are intradialytic hypotension with nursing intervention and patient symptoms, intradialytic hypotension with symptoms, lowest blood pressure less than 100 mmHg, ability to achieve dry weight, postural hypotension at the end of dialysis and maximum fluid removal. Postural hypotension is defined as a systolic blood pressure decrease of at least 20 mm Hg or a diastolic blood pressure decrease of at least 10 mm Hg within three minutes of standing.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65150 0
Dr Kim Wong
Address 65150 0
Department of Nephrology
Peninsula Health
2 Hastings Road
Frankston
Victoria
VIC 3199
Australia
Country 65150 0
Australia
Phone 65150 0
+61439228338
Fax 65150 0
Email 65150 0
kwong@phcn.vic.gov.au
Contact person for public queries
Name 65151 0
Dr Minh Huan Dang
Address 65151 0
Department of Nephrology
Peninsula Health
2 Hastings Road
Frankston
Victoria
VIC 3199
Australia
Country 65151 0
Australia
Phone 65151 0
+61423933043
Fax 65151 0
Email 65151 0
huandg341@gmail.com
Contact person for scientific queries
Name 65152 0
Dr Minh Huan Dang
Address 65152 0
Department of Nephrology
Peninsula Health
2 Hastings Road
Frankston
Victoria
VIC 3199
Australia
Country 65152 0
Australia
Phone 65152 0
+61423933043
Fax 65152 0
Email 65152 0
huandg341@gmail.com

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