Pneumatic Compression Stockings During Hemodialysis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Jennifer MacRae, University of Calgary
ClinicalTrials.gov Identifier:
NCT01067170
First received: February 9, 2010
Last updated: December 12, 2012
Last verified: December 2012
  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: 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 University of Calgary:

Primary Outcome Measures:
  • Central blood volume [ Time Frame: pre and post hemodialysis ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cardiac output [ Time Frame: pre and post hemodialysis ] [ Designated as safety issue: No ]
  • cardiac index [ Time Frame: pre and post hemodialysis ] [ Designated as safety issue: No ]
  • systemic vascular resistance [ Time Frame: pre and post hemodialysis ] [ Designated as safety issue: No ]
  • intracellular fluid volume [ Time Frame: pre and post hemodialysis ] [ Designated as safety issue: No ]
  • extracellular fluid volume [ Time Frame: pre and post hemodialysis ] [ Designated as safety issue: No ]
  • total body water [ Time Frame: pre and post hemodialysis ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: February 9, 2010
Last Updated: December 12, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Calgary:
Hemodialysis
Intradialytic hypotension

ClinicalTrials.gov processed this record on July 24, 2014