Pneumatic Compression Stockings During Hemodialysis

December 12, 2012 updated by: Dr Jennifer MacRae, University of Calgary

The Effect of Pneumatic Compression Stockings on Hemodynamic Parameters in Hemodialysis Patients: A Randomized Crossover Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • University of Calgary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pneumatic compression stockings
Device: Pneumatic Compression Stockings
Thigh-high pneumatic compression stockings

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Central blood volume
Time Frame: pre and post hemodialysis
pre and post hemodialysis

Secondary Outcome Measures

Outcome Measure
Time Frame
cardiac output
Time Frame: pre and post hemodialysis
pre and post hemodialysis
cardiac index
Time Frame: pre and post hemodialysis
pre and post hemodialysis
systemic vascular resistance
Time Frame: pre and post hemodialysis
pre and post hemodialysis
intracellular fluid volume
Time Frame: pre and post hemodialysis
pre and post hemodialysis
extracellular fluid volume
Time Frame: pre and post hemodialysis
pre and post hemodialysis
total body water
Time Frame: pre and post hemodialysis
pre and post hemodialysis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Investigators

  • Principal Investigator: Jennifer M MacRae, MD MSc, University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

February 9, 2010

First Submitted That Met QC Criteria

February 9, 2010

First Posted (Estimate)

February 11, 2010

Study Record Updates

Last Update Posted (Estimate)

December 13, 2012

Last Update Submitted That Met QC Criteria

December 12, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • E-21937

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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