Hemodynamic Responses in Hemodialysis Patients to Blood Flow Restriction Using Non-pneumatic Anti-shock Garments

Study Overview
=================
Brief 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 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.

Official Title
-----------------
Study to Examine the Hemodynamic Responses in Hemodialysis Patients to Blood Flow Restriction Using Non-pneumatic Anti-shock Garments

Conditions
-----------------
Blood Pressure

Intervention / Treatment
-----------------
* Device: Application of Antishock garment


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Healthy participants<br>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. | Device: Application of Antishock garment<br>* 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.<br>|
| Active Comparator: CKD patients not on dialysis<br>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. | Device: Application of Antishock garment<br>* 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.<br>|
| Active Comparator: CKD patients on Dialysis<br>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. | Device: Application of Antishock garment<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of blood pressure changes with and without garment application | 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. | 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. | 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. | 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. | 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antishock Garment