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

NCT02915627 | Completed

• 1 other identifier: 108183
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure

Keywords

Antishock Garment

Outcome Measures

Primary Outcomes (1)

• Assessment of blood pressure changes with and without garment application

  a measurement of blood pressure upon application of the non-pneumatic anti-shock garments

  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 (4)

• 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 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.

• 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.

Study Arms (3)

Healthy participants

ACTIVE COMPARATOR

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

CKD patients not on dialysis

ACTIVE COMPARATOR

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

CKD patients on Dialysis

ACTIVE COMPARATOR

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

Interventions

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.

CKD patients not on dialysis; CKD patients on Dialysis; Healthy participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Related Publications (1)

• 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.

  PMID: 31937266 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, UWO

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: September 27, 2016
• Study Start: November 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 25, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)