Hemodynamic Responses in Hemodialysis Patients to Blood Flow Restriction Using Non-pneumatic Anti-shock Garments
January 22, 2018 updated by: Chris McIntyre, Lawson Health Research Institute
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A 5W9
- London Health Sciences Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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
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
Exclusion Criteria:
- Not meeting inclusion criteria
- Severe heart failure (New York Heart Association grade IV)
- Pulmonary hypertension
- Mitral stenosis
- Cardiac transplant recipients
- Mental incapacity to consent
- Declined to participate
- Absence of lower limbs or lower limb injury
- Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Healthy participants
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.
|
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.
|
|
Active Comparator: CKD patients not on dialysis
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.
|
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.
|
|
Active Comparator: CKD patients on Dialysis
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
baroreflex sensitivity; upon application of the anti-shock garments;
|
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.
|
trends in beat-to-beat blood pressure upon application of the anti-shock garments
|
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.
|
Participant tolerability of the anti-shock garments
|
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.
|
changes in ejection fraction upon application of anti-shock 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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2016
Primary Completion (Actual)
September 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
September 14, 2016
First Submitted That Met QC Criteria
September 23, 2016
First Posted (Estimate)
September 27, 2016
Study Record Updates
Last Update Posted (Actual)
January 25, 2018
Last Update Submitted That Met QC Criteria
January 22, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 108183
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.