The effect of pneumatic compression stockings in haemodialysis patients: a randomised crossover trial
| ISRCTN | ISRCTN74510183 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74510183 |
| Secondary identifying numbers | N/A |
- Submission date
- 12/11/2008
- Registration date
- 23/12/2008
- Last edited
- 23/12/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jennifer MacRae
Scientific
Scientific
Foothills Medical Centre
C210, 1403 29th Street NW
Calgary
T2N 2T9
Canada
| Phone | +1 403 944 8168 |
|---|---|
| jennifer.macrae@calgaryhealthregion.ca |
Study information
| Study design | Randomised single centre active-controlled crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The effect of pneumatic compression stockings on haemodynamic parameters in haemodialysis patients: a randomised crossover trial |
| Study objectives | 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(s) | The University of Calgary Office of Medical Bioethics approved on 2nd October 2008 (ref: ED-21937) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/12/2008 |
| Completion date | 01/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 51 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2008 |
| Date of final enrolment | 01/12/2010 |
Locations
Countries of recruitment
- Canada
Study participating centre
Foothills Medical Centre
Calgary
T2N 2T9
Canada
T2N 2T9
Canada
Sponsor information
University of Calgary (Canada)
University/education
University/education
c/o Jennifer MacRae
Foothills Medical Centre
Calgary Health Region
C210 1403-29th Street NW
Calgary
T2N 2T9
Canada
| Phone | +1 403 944 8168 |
|---|---|
| jennifer.macrae@calgaryhealthregion.ca | |
"ROR" |
https://ror.org/03yjb2x39 |
Funders
Funder type
University/education
University of Calgary (Canada) - Faculty of Medicine, Division of Nephrology
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
