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

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ClinicalTrials.gov Identifier: NCT02915627
Recruitment Status : Completed
First Posted : September 27, 2016
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Chris McIntyre, 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.

Condition or disease Intervention/treatment Phase
Blood Pressure Device: Application of Antishock garment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Study to Examine the Hemodynamic Responses in Hemodialysis Patients to Blood Flow Restriction Using Non-pneumatic Anti-shock Garments
Study Start Date : November 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Shock

Arm Intervention/treatment
Active Comparator: 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.
Device: Application of Antishock garment
anti-shock garments are applied. Participants will then be examined for two 15 minute intervals with and without the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed.

Active Comparator: 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.
Device: Application of Antishock garment
anti-shock garments are applied. Participants will then be examined for two 15 minute intervals with and without the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed.

Active Comparator: 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.
Device: Application of Antishock garment
anti-shock garments are applied. Participants will then 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 :
  1. Assessment of blood pressure changes with and without garment application [ Time Frame: 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 :
  1. Assessment of changes in Baroreflex Sensitivity with and without garment application. [ Time Frame: 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;

  2. Assessment of changes in trends in beat to beat blood pressure with and without garment application. [ Time Frame: 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

  3. Assessment of participant tolerability with garment application. [ Time Frame: 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

  4. Assessment of changes in ejection fraction with and without garment application. [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02915627


Locations
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Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
Sponsors and Collaborators
Lawson Health Research Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chris McIntyre, Professor of Medicine, UWO, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02915627    
Other Study ID Numbers: 108183
First Posted: September 27, 2016    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Chris McIntyre, Lawson Health Research Institute:
Antishock Garment