Respirophasic Carotid Artery Peak Velocity Variation as a Predictor of Fluid Responsiveness in Patients With Coronary Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01836081
First received: April 10, 2013
Last updated: April 18, 2013
Last verified: April 2013

April 10, 2013
April 18, 2013
December 2011
December 2012   (final data collection date for primary outcome measure)
Predictive power of the respirophasic carotid flow peak velocity variation for the fluid responsiveness [ Time Frame: Measurement of respirophasic carotid flow peak velocity variation before the volume expansion ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01836081 on ClinicalTrials.gov Archive Site
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Respirophasic Carotid Artery Peak Velocity Variation as a Predictor of Fluid Responsiveness in Patients With Coronary Disease
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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.

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Interventional
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Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Coronary Artery Occlusive Disease
Other: Volume expansion
Other Name: volume expansion with 6 mL/kg of 6% hydroxylethyl starch 130/0.4
Experimental: fluid responsiveness
Intervention: Other: Volume expansion
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  1. cardiac rhythm other than sinus
  2. congestive heart failure
  3. left ventricular ejection fraction <35%
  4. history of transient ischemic attack
  5. pre-existing cerebrovascular disease and peripheral arterial occlusive disease
  6. presence of carotid artery stenosis >50%
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01836081
4-2011-0687
No
Yonsei University
Yonsei University
Not Provided
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Yonsei University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP