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

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02915627
• Other study ID #: 108183
• Status: Completed
• Phase: N/A
• First received: September 14, 2016
• Last updated: January 22, 2018
• Start date: November 2016
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Healthy participants

1. Male and female, age=18 years old

2. No clinical diagnosis of CKD

CKD patients not on dialysis

1. Male and female, age=18 years old

2. Stage 4 or Stage 5 CKD patients

CKD patients on dialysis

1. Male and female, age=18 years old

2. Patients having haemodialysis treatment at least 3 times per week at a London Health Sciences Centre facility

Exclusion Criteria:

1. Not meeting inclusion criteria

2. Severe heart failure (New York Heart Association grade IV)

3. Pulmonary hypertension

4. Mitral stenosis

5. Cardiac transplant recipients

6. Mental incapacity to consent

7. Declined to participate

8. Absence of lower limbs or lower limb injury

9. Pregnancy

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Device:
• Application of Antishock garment
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.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.