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Completed

NCT Number: NCT02915627

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

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.

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Key information

Conditions

Blood Pressure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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
  • Pregnancy

Treatment and study plan

Application of Antishock garment

Device

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 27, 2016
Registry last updated
Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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