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

History of Changes

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:

MedlinePlus related topics: Dialysis

U.S. FDA Resources

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

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:

Tai DJ, Ahmed SB, Palacios-Derflingher L, Hemmelgarn BR, Macrae JM; for the Alberta Kidney Disease Network. Pneumatic compression devices during hemodialysis: a randomized crossover trial. Nephrol Dial Transplant. 2012 Nov 7. [Epub ahead of print]

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 May 23, 2013

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