NCT01067170

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 11, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

December 13, 2012

Status Verified

December 1, 2012

Enrollment Period

2.3 years

First QC Date

February 9, 2010

Last Update Submit

December 12, 2012

Conditions

Hemodialysis

Keywords

HemodialysisIntradialytic hypotension

Outcome Measures

Primary Outcomes (1)

  • Central blood volume

    pre and post hemodialysis

Secondary Outcomes (6)

  • cardiac output

    pre and post hemodialysis

  • cardiac index

    pre and post hemodialysis

  • systemic vascular resistance

    pre and post hemodialysis

  • intracellular fluid volume

    pre and post hemodialysis

  • extracellular fluid volume

    pre and post hemodialysis

  • +1 more secondary outcomes

Study Arms (1)

Pneumatic compression stockings

EXPERIMENTAL
Device: Pneumatic Compression Stockings

Interventions

Pneumatic Compression StockingsDEVICE

Thigh-high pneumatic compression stockings

Pneumatic compression stockings

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • dialyzing with a central venous catheter
  • vascular access dysfunction
  • peripheral vascular disease
  • active medical issue
  • unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 2T9, Canada

Location

Related Publications (1)

  • Tai DJ, Ahmed SB, Palacios-Derflingher L, Hemmelgarn BR, MacRae JM; Alberta Kidney Disease Network. Pneumatic compression devices during hemodialysis: a randomized crossover trial. Nephrol Dial Transplant. 2013 Apr;28(4):982-90. doi: 10.1093/ndt/gfs502. Epub 2012 Nov 7.

    PMID: 23136215RESULT

MeSH Terms

Interventions

Intermittent Pneumatic Compression Devices

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Jennifer M MacRae, MD MSc

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Hemodialysis and Vascular Access

Study Record Dates

First Submitted

February 9, 2010

First Posted

February 11, 2010

Study Start

November 1, 2008

Primary Completion

February 1, 2011

Study Completion

August 1, 2012

Last Updated

December 13, 2012

Record last verified: 2012-12

Locations

CA(1)