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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
  Purpose

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 Intervention
Coronary Artery Occlusive Disease
Other: Volume expansion

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 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.


Enrollment: 40
Study Start Date: December 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: fluid responsiveness Other: Volume expansion
Other Name: volume expansion with 6 mL/kg of 6% hydroxylethyl starch 130/0.4

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01836081

Locations
Korea, Republic of
Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided by Yonsei University

Additional 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
Study First Received: April 10, 2013
Last Updated: April 18, 2013
Health Authority: Korea: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 25, 2014