NCT01836081

Brief Summary

The aim of this study is to investigate usefulness of the respirophasic variation in carotid artery peak flow velocity measured by Doppler ultrasound, which is noninvasive and easily accessible, as a predictor of fluid responsiveness in patients with coronary artery disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2011

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 19, 2013

Completed
Last Updated

April 19, 2013

Status Verified

April 1, 2013

Enrollment Period

1 year

First QC Date

April 10, 2013

Last Update Submit

April 18, 2013

Conditions

Keywords

fluid responsivenesscarotid artery peak velocity variationcoronary disease

Outcome Measures

Primary Outcomes (1)

  • Predictive power of the respirophasic carotid flow peak velocity variation for the fluid responsiveness

    After induction of anesthesia, peak velocity of carotid artery blood flow is measured by the pulsed wave Doppler signal obtained from the left common carotid artery. Respirophasic variation of the peak velocity is defined as the difference between the maximum and the minimum values of peak velocity divided by the mean of the two values during one respiratory cycle. Fluid responder is defined as a patient whose stroke volume index is increased ≥15% after volume expansion. The receiver operating characteristic curve analysis to descriminiate fluid responder is performed.

    Measurement of respirophasic carotid flow peak velocity variation before the volume expansion

Study Arms (1)

fluid responsiveness

EXPERIMENTAL
Other: Volume expansion

Interventions

Also known as: volume expansion with 6 mL/kg of 6% hydroxylethyl starch 130/0.4
fluid responsiveness

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. patients scheduled for elective isolated off-pump coronary artery bypass graft surgery

You may not qualify if:

  • cardiac rhythm other than sinus
  • congestive heart failure
  • left ventricular ejection fraction \<35%
  • history of transient ischemic attack
  • pre-existing cerebrovascular disease and peripheral arterial occlusive disease
  • presence of carotid artery stenosis \>50%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University College of Medicine

Seoul, Seoul, 120-752, South Korea

Location

Related Publications (1)

  • Song Y, Kwak YL, Song JW, Kim YJ, Shim JK. Respirophasic carotid artery peak velocity variation as a predictor of fluid responsiveness in mechanically ventilated patients with coronary artery disease. Br J Anaesth. 2014 Jul;113(1):61-6. doi: 10.1093/bja/aeu057. Epub 2014 Apr 9.

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2013

First Posted

April 19, 2013

Study Start

December 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

April 19, 2013

Record last verified: 2013-04

Locations