Study to Examine the Hemodynamic Responses in Hemodialysis Patients to Blood Flow Restriction Using Non-pneumatic Anti-shock Garments
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Assessment of blood pressure changes with and without garment application
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants
- •Male and female, age≥18 years old
- •No clinical diagnosis of CKD
- •CKD patients not on dialysis
- •Male and female, age≥18 years old
- •Stage 4 or Stage 5 CKD patients
- •CKD patients on dialysis
- •Male and female, age≥18 years old
- •Patients having haemodialysis treatment at least 3 times per week at a London Health Sciences Centre facility
排除标准
- •Not meeting inclusion criteria
- •Severe heart failure (New York Heart Association grade IV)
- •Pulmonary hypertension
- •Mitral stenosis
- •Cardiac transplant recipients
- •Mental incapacity to consent
- •Declined to participate
- •Absence of lower limbs or lower limb injury
研究组 & 干预措施
Healthy participants
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.
干预措施: Application of Antishock garment (Device)
CKD patients not on dialysis
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.
干预措施: Application of Antishock garment (Device)
CKD patients on Dialysis
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.
干预措施: Application of Antishock garment (Device)
结局指标
主要结局
Assessment of blood pressure changes with and without garment application
时间窗: 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
次要结局
- 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.)
- 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.)
- 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.)
- 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.)
研究者
Chris McIntyre
Professor of Medicine, UWO
Lawson Health Research Institute