Pneumatic Compression Stockings During Hemodialysis | NCT01067170

Studies
Pneumatic Compression Stockings During Hemodialysis

NCT01067170

Sponsor

University of Calgary

Status

Completed

Last Update Posted

Dec 13, 2012Estimated

Enrollment

51Actual

Phase

Not Applicable

Conditions

Hemodialysis

Interventions

Pneumatic Compression Stockings

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Feb 2011Actual

Completion Date

Aug 2012Actual

First Submitted Date

Feb 9, 2010

First Submission Date that Met QC Criteria

Feb 9, 2010

First Posted Date

Feb 11, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2012

Last Update Posted Date

Dec 13, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Jennifer MacRae, Director, Hemodialysis and Vascular Access, University of CalgaryPrincipal Investigator

Lead Sponsor

University of CalgaryOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

51Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pneumatic compression stockings	Experimental		Device: Pneumatic Compression Stockings

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pneumatic Compression Stockings	Device	Thigh-high pneumatic compression stockings	Pneumatic compression stockings

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Central blood volume		pre and post hemodialysis

Secondary Outcomes

Measure	Description	Time Frame
cardiac output		pre and post hemodialysis
cardiac index		pre and post hemodialysis
systemic vascular resistance

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jennifer M MacRae, MD MSc	University of Calgary	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Calgary		Calgary	Alberta	T2N 2T9	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23136215	Result	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.

Type	Date	Date Unknown
Release	Aug 16, 2016
Reset	Oct 6, 2016