Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2026-01-24 @ 10:17 AM
Study NCT ID:
NCT02915627
Status:
COMPLETED
Last Update Posted:
2018-01-25
First Post:
2016-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemodynamic Responses in Hemodialysis Patients to Blood Flow Restriction Using Non-pneumatic Anti-shock Garments
Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Organization:
Study Overview
Official Title:
Study to Examine the Hemodynamic Responses in Hemodialysis Patients to Blood Flow Restriction Using Non-pneumatic Anti-shock Garments
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: