Blood PressureNCT02915627
Hemodynamic Responses in Hemodialysis Patients to Blood Flow Restriction Using Non-pneumatic Anti-shock Garments
A study testing Application of Antishock garment in people with Blood Pressure, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Study comparing different groups of people and how they respond to application of the non-pneumatic anti-shock garments. Investigators will divide all recruited participants into three groups based on health status (group 1: hemodialysis patients; group 2: patients with severe chronic kidney disease but not on… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Application of Antishock garment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2016to Dec 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy participants
- Male and female, age≥18 years old
- No clinical diagnosis of CKD
- CKD patients not on dialysis
- Male and female, age≥18 years old
- Stage 4 or Stage 5 CKD patients
Show all 9Show fewer
- CKD patients on dialysis
- Male and female, age≥18 years old
- Patients having haemodialysis treatment at least 3 times per week at a London Health Sciences Centre facility
Who cannot join
- Not meeting inclusion criteria
- Severe heart failure (New York Heart Association grade IV)
- Pulmonary hypertension
- Mitral stenosis
- Cardiac transplant recipients
- Mental incapacity to consent
Show all 9Show fewer
- Declined to participate
- Absence of lower limbs or lower limb injury
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Examine the Hemodynamic Responses in Hemodialysis Patients to Blood Flow Restriction Using Non-pneumatic Anti-shock Garments
Study comparing different groups of people and how they respond to application of the non-pneumatic anti-shock garments. Investigators will divide all recruited participants into three groups based on health status (group 1: hemodialysis patients; group 2: patients with severe chronic kidney disease but not on dialysis; group 3: healthy participants with no clinically known kidney disease). Each group, which will comprise of 10 people, will receive the same treatment using the non-pneumatic anti-shock garments.
Read the detailed description
Primary Aim: To determine how blood flow restriction to the lower extremities using non-pneumatic anti-shock garments affects hemodynamic and cardiovascular parameters such as blood pressure in Hemodialysis (HD) patients while they are not on dialysis.
Investigators propose a pilot study to assess the effects of blood flow restriction using non-pneumatic anti-shock garments in HD patients while they are not on dialysis.
Outcomes: The primary objective will be a measurement of blood pressure upon application of the non-pneumatic anti-shock garments.
Secondary outcomes will include the following: baroreflex sensitivity; trends in beat-to-beat blood pressure upon application of the anti-shock garments; patient tolerability of the non-pneumatic anti-shock garments, ejection fraction via echocardiogram analyses.
- Conditions
- Blood Pressure
- Being tested
- Application of Antishock garment
- Keywords
- Antishock Garment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of Antishock garmentDevice
anti-shock garments are applied. Participants will then be examined for two 15 minute intervals with and without the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants | Active comparator | Non chronic kidney disease (CKD) participants. Intervention: Application of antishock garment. Participants will be examined for two 15 minute intervals with and without the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed. Receives: Device: Application of Antishock garment |
| CKD patients not on dialysis | Active comparator | CKD 4/5 patients not on Dialysis- Intervention: Application of antishock garment. Participants will be examined for two 15 minute intervals with and without the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed. Receives: Device: Application of Antishock garment |
| CKD patients on Dialysis | Active comparator | Patients having haemodialysis treatment at least 3 times per week at a London Health Sciences Centre facility-Intervention: Application of antishock garment. Participants will be examined for two 15 minute intervals with and without the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed. Receives: Device: Application of Antishock garment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of blood pressure changes with and without garment application
a measurement of blood pressure upon application of the non-pneumatic anti-shock garments
Measured: Participants will be examined for two 15 minute intervals with and without the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed.
Secondary outcomes (4)
Assessment of changes in Baroreflex Sensitivity with and without garment application.
baroreflex sensitivity; upon application of the anti-shock garments;
Measured: Participants will be examined for two 15 minute intervals with and without the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed.
Assessment of changes in trends in beat to beat blood pressure with and without garment application.
trends in beat-to-beat blood pressure upon application of the anti-shock garments
Measured: Participants will be examined for two 15 minute intervals with and without the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed.
Assessment of participant tolerability with garment application.
Participant tolerability of the anti-shock garments
Measured: Participants will be examined for a 15 minute interval with the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed.
Assessment of changes in ejection fraction with and without garment application.
changes in ejection fraction upon application of anti-shock garment
Measured: Participants will be examined for two 15 minute intervals with and without the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startNov 2016
- Primary completionSep 2017
- Study completionDec 2017
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 Blood PressureStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chris McIntyre, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02915627
- Sponsor's protocol ID
- 108183
- Status last verified
- Jan 2018
- First submitted
- 14 Sep 2016
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Marinovich R, Li Z, Tamasi T, Quinn K, Wong S, McIntyre CW. Hemodynamic response to non-pneumatic anti-shock compression garments in patients with renal dysfunction. BMC Nephrol. 2020 Jan 14;21(1):15. doi: 10.1186/s12882-019-1680-8.
PubMed 31937266
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Examine the Hemodynamic Responses in Hemodialysis Patients to Blood Flow Restriction Using Non-pneumatic Anti-shock Garments
- ClinicalTrials.gov ID
- NCT02915627
- Acronym / sponsor ID
- 108183
- Conditions
- Blood Pressure
- Keywords
- Antishock Garment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 27 Sep 2016 (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.
Study comparing different groups of people and how they respond to application of the non-pneumatic anti-shock garments. Investigators will divide all recruited participants into three groups based on health status (group 1: hemodialysis patients; group 2: patients with severe chronic kidney disease but not on dialysis; group 3: healthy participants with no clinically known kidney disease). Each group, which will comprise of 10 people, will receive the same treatment using the non-pneumatic anti-shock garments.
Detailed description
Primary Aim: To determine how blood flow restriction to the lower extremities using non-pneumatic anti-shock garments affects hemodynamic and cardiovascular parameters such as blood pressure in Hemodialysis (HD) patients while they are not on dialysis.
Investigators propose a pilot study to assess the effects of blood flow restriction using non-pneumatic anti-shock garments in HD patients while they are not on dialysis.
Outcomes: The primary objective will be a measurement of blood pressure upon application of the non-pneumatic anti-shock garments.
Secondary outcomes will include the following: baroreflex sensitivity; trends in beat-to-beat blood pressure upon application of the anti-shock garments; patient tolerability of the non-pneumatic anti-shock garments, ejection fraction via echocardiogram analyses.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | Active comparator | Device: Application of Antishock garmentNon chronic kidney disease (CKD) participants. Intervention: Application of antishock garment. Participants will be examined for two 15 minute intervals with and without the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed. |
| CKD patients not on dialysis | Active comparator | Device: Application of Antishock garmentCKD 4/5 patients not on Dialysis- Intervention: Application of antishock garment. Participants will be examined for two 15 minute intervals with and without the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed. |
| CKD patients on Dialysis | Active comparator | Device: Application of Antishock garmentPatients having haemodialysis treatment at least 3 times per week at a London Health Sciences Centre facility-Intervention: Application of antishock garment. Participants will be examined for two 15 minute intervals with and without the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy participants
- Male and female, age≥18 years old
- No clinical diagnosis of CKD
- CKD patients not on dialysis
- Male and female, age≥18 years old
Key exclusion criteria (9 listed)
- Not meeting inclusion criteria
- Severe heart failure (New York Heart Association grade IV)
- Pulmonary hypertension
- Mitral stenosis
- Cardiac transplant recipients
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 |
|---|---|---|
| Application of Antishock garmentanti-shock garments are applied. Participants will then be examined for two 15 minute intervals with and without the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed. | Device | CKD patients not on dialysis, CKD patients on Dialysis, Healthy participants |
Primary outcome
Assessment of blood pressure changes with and without garment application
Time frame: Participants will be examined for two 15 minute intervals with and without the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed.
a measurement of blood pressure upon application of the non-pneumatic anti-shock garments
4 secondary outcomes
Assessment of changes in Baroreflex Sensitivity with and without garment application.
Time frame: Participants will be examined for two 15 minute intervals with and without the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed.
Assessment of changes in trends in beat to beat blood pressure with and without garment application.
Time frame: Participants will be examined for two 15 minute intervals with and without the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed.
Assessment of participant tolerability with garment application.
Time frame: Participants will be examined for a 15 minute interval with the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed.
Assessment of changes in ejection fraction with and without garment application.
Time frame: Participants will be examined for two 15 minute intervals with and without the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed.
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 25 Jan 2018.
- Derived from this study: PubMed 31937266Marinovich R, Li Z, Tamasi T, Quinn K, Wong S, McIntyre CW. Hemodynamic response to non-pneumatic anti-shock compression garments in patients with renal dysfunction. BMC Nephrol. 2020 Jan 14;21(1):15. doi: 10.1186/s12882-019-1680-8.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of Antishock garment in people with Blood Pressure, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 9 inclusion and 9 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 25 Jan 2018. 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?
Assessment of blood pressure changes with and without garment application (time frame: Participants will be examined for two 15 minute intervals with and without the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed.). 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 NCT02915627, 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 25 Jan 2018.