Respirophasic Carotid Artery Peak Velocity Variation as a Predictor of Fluid Responsiveness in Patients With Coronary Disease
This study has been completed.
Sponsor:
Yonsei University
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
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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 |
Resource links provided by NLM:
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:
- 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%
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01836081
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 |
ClinicalTrials.gov processed this record on February 27, 2015