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Pneumatic Compression Stockings During Hemodialysis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01067170
First Posted: February 11, 2010
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr Jennifer MacRae, University of Calgary
  Purpose
This study aims to determine the effect of pneumatic compression devices (PCDs) on central blood volume in hemodialysis patients. We hypothesize that PCDs will help maintain central blood volume, and therefore prevent sudden decreases in blood pressure during hemodialysis.

Condition Intervention
Hemodialysis Device: Pneumatic Compression Stockings

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Pneumatic Compression Stockings on Hemodynamic Parameters in Hemodialysis Patients: A Randomized Crossover Trial

Resource links provided by NLM:


Further study details as provided by Dr Jennifer MacRae, University of Calgary:

Primary Outcome Measures:
  • Central blood volume [ Time Frame: pre and post hemodialysis ]

Secondary Outcome Measures:
  • cardiac output [ Time Frame: pre and post hemodialysis ]
  • cardiac index [ Time Frame: pre and post hemodialysis ]
  • systemic vascular resistance [ Time Frame: pre and post hemodialysis ]
  • intracellular fluid volume [ Time Frame: pre and post hemodialysis ]
  • extracellular fluid volume [ Time Frame: pre and post hemodialysis ]
  • total body water [ Time Frame: pre and post hemodialysis ]

Enrollment: 51
Study Start Date: November 2008
Study Completion Date: August 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pneumatic compression stockings Device: Pneumatic Compression Stockings
Thigh-high pneumatic compression stockings

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • on hemodialysis at least 3 months
  • on hemodialysis at least 3 times per week

Exclusion Criteria:

  • dialyzing with a central venous catheter
  • vascular access dysfunction
  • peripheral vascular disease
  • active medical issue
  • unable to provide informed consent
  Contacts and Locations
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): NCT01067170


Locations
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 2T9
Sponsors and Collaborators
University of Calgary
Investigators
Principal Investigator: Jennifer M MacRae, MD MSc University of Calgary
  More Information

Publications:
Responsible Party: Dr Jennifer MacRae, Director, Hemodialysis and Vascular Access, University of Calgary
ClinicalTrials.gov Identifier: NCT01067170     History of Changes
Other Study ID Numbers: E-21937
First Submitted: February 9, 2010
First Posted: February 11, 2010
Last Update Posted: October 12, 2017
Last Verified: December 2012

Keywords provided by Dr Jennifer MacRae, University of Calgary:
Hemodialysis
Intradialytic hypotension