None listed
Conditions
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.
Interventions
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 particip
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).
Sponsors
Dr. Kim Wong
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed