HemodialysisNCT01067170
Pneumatic Compression Stockings During Hemodialysis
A study testing Pneumatic Compression Stockings in people with Hemodialysis, run by University of Calgary at 1 site in Canada.
Trial summary
This study aims to determine the effect of pneumatic compression devices (PCDs) on central blood volume in hemodialysis patients. We hypothesize that PCDs will help maintain central blood volume, and therefore prevent sudden decreases in blood pressure during hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis
- What is being tested?
- Pneumatic Compression Stockings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2008to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- on hemodialysis at least 3 months
- on hemodialysis at least 3 times per week
Who cannot join
- dialyzing with a central venous catheter
- vascular access dysfunction
- peripheral vascular disease
- active medical issue
- unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pneumatic Compression Stockings on Hemodynamic Parameters in Hemodialysis Patients: A Randomized Crossover Trial
This study aims to determine the effect of pneumatic compression devices (PCDs) on central blood volume in hemodialysis patients. We hypothesize that PCDs will help maintain central blood volume, and therefore prevent sudden decreases in blood pressure during hemodialysis.
- Conditions
- Hemodialysis
- Being tested
- Pneumatic Compression Stockings
- Keywords
- Hemodialysis, Intradialytic hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumatic Compression StockingsDevice
Thigh-high pneumatic compression stockings
| Study group | Role | What they receive |
|---|---|---|
| Pneumatic compression stockings | Experimental | Not described Receives: Device: Pneumatic Compression Stockings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central blood volume
Measured: pre and post hemodialysis
Secondary outcomes (6)
cardiac output
Measured: pre and post hemodialysis
cardiac index
Measured: pre and post hemodialysis
systemic vascular resistance
Measured: pre and post hemodialysis
intracellular fluid volume
Measured: pre and post hemodialysis
extracellular fluid volume
Measured: pre and post hemodialysis
total body water
Measured: pre and post hemodialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2010 (estimated)
- Study startNov 2008
- Primary completionFeb 2011
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Jennifer MacRae, University of Calgary
- Investigators
- Jennifer M MacRae, MD MSc, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067170
- Sponsor's protocol ID
- E-21937
- Status last verified
- Dec 2012
- First submitted
- 9 Feb 2010
- Last updated
- 13 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Tai DJ, Ahmed SB, Palacios-Derflingher L, Hemmelgarn BR, MacRae JM; Alberta Kidney Disease Network. Pneumatic compression devices during hemodialysis: a randomized crossover trial. Nephrol Dial Transplant. 2013 Apr;28(4):982-90. doi: 10.1093/ndt/gfs502. Epub 2012 Nov 7.
PubMed 23136215
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pneumatic Compression Stockings on Hemodynamic Parameters in Hemodialysis Patients: A Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT01067170
- Acronym / sponsor ID
- E-21937
- Conditions
- Hemodialysis
- Keywords
- Hemodialysis, Intradialytic hypotension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 11 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine the effect of pneumatic compression devices (PCDs) on central blood volume in hemodialysis patients. We hypothesize that PCDs will help maintain central blood volume, and therefore prevent sudden decreases in blood pressure during hemodialysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pneumatic compression stockings | Experimental | Device: Pneumatic Compression Stockings |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- on hemodialysis at least 3 months
- on hemodialysis at least 3 times per week
Key exclusion criteria (5 listed)
- dialyzing with a central venous catheter
- vascular access dysfunction
- peripheral vascular disease
- active medical issue
- unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pneumatic Compression StockingsThigh-high pneumatic compression stockings | Device | Pneumatic compression stockings |
Primary outcome
Central blood volume
Time frame: pre and post hemodialysis
6 secondary outcomes
cardiac output
Time frame: pre and post hemodialysis
cardiac index
Time frame: pre and post hemodialysis
systemic vascular resistance
Time frame: pre and post hemodialysis
intracellular fluid volume
Time frame: pre and post hemodialysis
extracellular fluid volume
Time frame: pre and post hemodialysis
total body water
Time frame: pre and post hemodialysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2012.
- Results publication: PubMed 23136215Tai DJ, Ahmed SB, Palacios-Derflingher L, Hemmelgarn BR, MacRae JM; Alberta Kidney Disease Network. Pneumatic compression devices during hemodialysis: a randomized crossover trial. Nephrol Dial Transplant. 2013 Apr;28(4):982-90. doi: 10.1093/ndt/gfs502. Epub 2012 Nov 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer M MacRae, MD MSc principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pneumatic Compression Stockings in people with Hemodialysis, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central blood volume (time frame: pre and post hemodialysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01067170, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2012.