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

Lawson Health Research Institute

Status: Completed

Conditions: Blood Pressure

Treatments: Device: Application of Antishock garment

Study type: Interventional

Funder types: Other

Identifiers

NCT02915627

108183

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 3 patient groups

Healthy participants

Active Comparator group

Description:

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.

Treatment:

Device: Application of Antishock garment

CKD patients not on dialysis

Active Comparator group

Description:

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.

Treatment:

Device: Application of Antishock garment

CKD patients on Dialysis

Active Comparator group

Description:

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.

Treatment:

Device: Application of Antishock garment