Contact information
Type
Scientific
Primary contact
Dr Jennifer MacRae
ORCID ID
Contact details
Foothills Medical Centre
C210
1403 29th Street NW
Calgary
T2N 2T9
Canada
+1 403 944 8168
jennifer.macrae@calgaryhealthregion.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The effect of pneumatic compression stockings on haemodynamic parameters in haemodialysis patients: a randomised crossover trial
Acronym
Study hypothesis
Primary hypothesis:
To determine the effect of pneumatic compression devices (PCDs), compared to standard of care, on central blood volume in both intradialytic hypotension (IDH) prone and non-IDH prone haemodialysis patients.
Secondary hypothesis:
To determine the effect of PCDs on the haemodynamic response during haemodialysis in both IDH-prone and non-IDH prone patients.
Ethics approval
The University of Calgary Office of Medical Bioethics approved on 2nd October 2008 (ref: ED-21937)
Study design
Randomised single centre active-controlled crossover trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
End-stage kidney disease on haemodialysis
Intervention
For sequence 1, the patient will undergo three HD sessions with PCDs, followed by three HD sessions without PCDs. For sequence 2, the patient will undergo three HD sessions without PCDs, followed by three sessions with PCDs. PCDs will be applied firmly around the calves prior to the initiation of HD with compressions intermittently applied at 40 mmHg throughout HD sessions. Frequencies of the compressions will be three cycles of compressions and decompressions per minute. Each cycle of compression and decompression will last approximately ten seconds. Lower extremities of all patients will be kept horizontal during the dialysis run.
The total duration of treatment is three consecutive HD sessions at 4 hours each; the follow up period is the same.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
The change in central blood volume with and without PCDs in both IDH-prone patients and non-IDH prone patients. Central blood volume will be determined using ultrasound dilution technique as per standard procedures. Determined within the first 30 minutes of HD and again within the last 15 minutes of the HD session; this is done for each of the study HD sessions (three with treatment, three with control).
Secondary outcome measures
Determined within the first 30 minutes of HD and again at the last 15 minutes of HD for each of the study sessions:
1. Cardiac output
2. Mean arterial pressure
3. Bioimpedance derived extracellular fluid (ECF) and intracellular fluid (ICF) values
Overall trial start date
01/12/2008
Overall trial end date
01/12/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Chronic stable HD patients who have been on HD at least three times per week for at least 3 months
2. Both males and females, aged 18 - 95 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
51
Participant exclusion criteria
1. Dialysing with a central venous catheter
2. Vascular access dysfunction
3. Lower extremity arterial ulcers, severe peripheral arterial disease, lower extremity amputations
4. Active medical issues
5. Unable to provide informed consent
Recruitment start date
01/12/2008
Recruitment end date
01/12/2010
Locations
Countries of recruitment
Canada
Trial participating centre
Foothills Medical Centre
Calgary
T2N 2T9
Canada
Sponsor information
Organisation
University of Calgary (Canada)
Sponsor details
c/o Jennifer MacRae
Foothills Medical Centre
Calgary Health Region
C210 1403-29th Street NW
Calgary
T2N 2T9
Canada
+1 403 944 8168
jennifer.macrae@calgaryhealthregion.ca
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Calgary (Canada) - Faculty of Medicine, Division of Nephrology
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary