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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Intradialytic hypotension

Condition category

Condition code

Renal and Urogenital

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]

Prevention

Intervention code [2]

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]

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]

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]

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]

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]

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]

Weight prior and after dialysis will be measured during the duration of the study.

Secondary outcome [3]

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]

Postural blood pressure (lying and standing) will be measured at the end of each dialysis session during the study.

Secondary outcome [4]

Maximum fluid removal.

The amount of fluid removed each dialysis session will be obtained by review of dialysis records.

Timepoint [4]

The amount of fluid removed will be recorded every dialysis session during the duration of the study.

Secondary outcome [5]

Symptomatic intradialytic hypotension, assessed by recording any hypotensive symptoms during dialysis and measuring blood pressure using sphygmomanometer.

Timepoint [5]

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]

Nadir blood pressure < 100

This will be assessed by measuring blood pressure using sphygmomanometer.

Timepoint [6]

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

Sex

Both males and females

Can healthy volunteers participate?

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

29/04/2016

Actual

30/05/2016

Date of last participant enrolment

Anticipated

13/05/2016

Actual

15/06/2016

Date of last data collection

Anticipated

30/09/2016

Actual

14/10/2016

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Frankston Hospital - Frankston

Recruitment postcode(s) [1]

3199 - Frankston

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Covidien

Address [1]

678 Victoria St
Richmond
Victoria
VIC 3121
Australia

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr. Kim Wong

Address

2 Hastings Road
Frankston
Victoria
VIC 3199
Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Peninsula Health Human Research and Ethics Committee

Ethics committee address [1]

2 Hastings Road
Frankston 
Victoria
VIC 3199 
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/04/2016

Approval date [1]

03/05/2016

Ethics approval number [1]

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

Dr Kim Wong

Address

Department of Nephrology
Peninsula Health
2 Hastings Road
Frankston
Victoria
VIC 3199
Australia

Country

Australia

Phone

+61439228338

Fax

kwong@phcn.vic.gov.au

Contact person for public queries

Name

Minh Huan Dang

Address

Department of Nephrology
Peninsula Health
2 Hastings Road
Frankston
Victoria
VIC 3199
Australia

Country

Australia

Phone

+61423933043

Fax

huandg341@gmail.com

Contact person for scientific queries

Name

Minh Huan Dang

Address

Department of Nephrology
Peninsula Health
2 Hastings Road
Frankston
Victoria
VIC 3199
Australia

Country

Australia

Phone

+61423933043

Fax

huandg341@gmail.com

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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