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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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ClinicalTrials.gov Identifier: NCT01836081
Recruitment Status : Completed
First Posted : April 19, 2013
Last Update Posted : April 19, 2013
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Artery Occlusive Disease Other: Volume expansion Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : December 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: fluid responsiveness Other: Volume expansion
Other Name: volume expansion with 6 mL/kg of 6% hydroxylethyl starch 130/0.4


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836081


Locations
Korea, Republic of
Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01836081     History of Changes
Other Study ID Numbers: 4-2011-0687
First Posted: April 19, 2013    Key Record Dates
Last Update Posted: April 19, 2013
Last Verified: April 2013

Keywords provided by Yonsei University:
fluid responsiveness
carotid artery peak velocity variation
coronary disease

Additional relevant MeSH terms:
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases