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

Not Applicable

Completed

• Conditions: Blood Pressure
• Interventions: Device: Application of Antishock garment

• Registration Number: NCT02915627
• Lead Sponsor: Lawson Health Research Institute

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-09-14
• Study First Submitted QC: 2016-09-23
• Study First Posted: 2016-09-27
• Study Start: 2016-11
• Primary Completion: 2017-09
• Study Completion: 2017-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-22
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy participants	Application of Antishock garment	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.
CKD patients not on dialysis	Application of Antishock garment	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.
CKD patients on Dialysis	Application of Antishock garment	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.

Primary Outcome Measures

Name	Time	Method
Assessment of blood pressure changes with and without garment application	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

Secondary Outcome Measures

Name	Time	Method
Assessment of changes in Baroreflex Sensitivity with and without garment application.	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;
Assessment of changes in trends in beat to beat blood pressure with and without garment application.	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
Assessment of changes in ejection fraction with and without garment application.	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
Assessment of participant tolerability with garment application.	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

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada