Clinical trial NCT02915627: Hemodynamic Responses in Hemodialysis Patients to Blood Flow Restriction Using Non-pneumatic Anti-shock Garments
Official title: Study to Examine the Hemodynamic Responses in Hemodialysis Patients to Blood Flow Restriction Using Non-pneumatic Anti-shock Garments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Keywords: Antishock Garment
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2016-09-27
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of blood pressure changes with and without garment application
timeFrame: 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 outcomes:
measure: Assessment of changes in Baroreflex Sensitivity with and without garment application.
timeFrame: 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.
measure: Assessment of changes in trends in beat to beat blood pressure with and without garment application.
timeFrame: 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.
measure: Assessment of participant tolerability with garment application.
timeFrame: Participants will be examined for a 15 minute interval with the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed.
measure: Assessment of changes in ejection fraction with and without garment application.
timeFrame: 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.
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
References:
citation: Marinovich R, Li Z, Tamasi T, Quinn K, Wong S, McIntyre CW. Hemodynamic response to non-pneumatic anti-shock compression garments in patients with renal dysfunction. BMC Nephrol. 2020 Jan 14;21(1):15. doi: 10.1186/s12882-019-1680-8.