NCT00500981

Brief Summary

The goal of this study is to evaluate whether measures of the size of the internal jugular vein have clinical utility in predicting whether patients may benefit from treatment with intravenous fluid.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2007

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

June 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 11, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

July 26, 2012

Status Verified

July 1, 2012

Enrollment Period

4 months

First QC Date

July 11, 2007

Last Update Submit

July 25, 2012

Conditions

Fluid TherapyCardiac Surgical Procedures

Keywords

Fluid responsiveness

Outcome Measures

Primary Outcomes (1)

  • To evaluate the relationship between the static size of the right IJV and fluid responsiveness in ventilated post-operative cardiac surgical patients.

    1 hour

Secondary Outcomes (1)

  • To evaluate the relationship between dynamic variations in the size of the right IJV related to respiration and leg-raising and fluid responsiveness in ventilated post-operative cardiac surgical patients.

    1 hour

Study Arms (1)

Intravenous fluid bolus

EXPERIMENTAL

Administration of 500 ml of 10% pentastarch

Procedure: Volume challengeProcedure: Ultrasound evaluation of internal jugular vein

Interventions

Volume challengePROCEDURE
Intravenous fluid bolus
Ultrasound evaluation of internal jugular veinPROCEDURE
Intravenous fluid bolus

Eligibility Criteria

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

You may qualify if:

  • Adults (\>18 years old)
  • Able to provide advanced informed consent
  • Planned elective or semi-urgent cardiac surgery

You may not qualify if:

  • Severe tricuspid regurgitation or planned tricuspid valve surgery
  • Congenital heart disease associated with cardiac shunting
  • Pre or post-operative presence of an intra-aortic balloon pump
  • Severe chronic obstructive pulmonary disease
  • Hemodynamic instability such that inotropes/vasopressor dosing is not constant
  • Respiratory instability and/or need for PEEP \> 5 cmH20

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foothills Medical Centre

Calgary, Alberta, T2N-2T9, Canada

Location

Study Officials

  • Dan Zuege, MD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor of Medicine

Study Record Dates

First Submitted

July 11, 2007

First Posted

July 13, 2007

Study Start

June 1, 2007

Primary Completion

October 1, 2007

Study Completion

December 1, 2008

Last Updated

July 26, 2012

Record last verified: 2012-07

Locations

CA(1)