Coronary Artery Occlusive DiseaseNCT01836081
Respirophasic Carotid Artery Peak Velocity Variation as a Predictor of Fluid Responsiveness in Patients With Coronary Disease
A study testing Volume expansion in people with Coronary Artery Occlusive Disease, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Occlusive Disease
- What is being tested?
- Volume expansion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. patients scheduled for elective isolated off-pump coronary artery bypass graft surgery
Who cannot join
- 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%
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University College of Medicine
Seoul, Seoul, 120-752
About this study
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.
- Conditions
- Coronary Artery Occlusive Disease
- Being tested
- Volume expansion
- Keywords
- fluid responsiveness, carotid artery peak velocity variation, coronary disease
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volume expansionOther
Also called volume expansion with 6 mL/kg of 6% hydroxylethyl starch 130/0.4
| Study group | Role | What they receive |
|---|---|---|
| fluid responsiveness | Experimental | Not described Receives: Other: Volume expansion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Measurement of respirophasic carotid flow peak velocity variation before the volume expansion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2013 (estimated)
- Study startDec 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Occlusive DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836081
- Sponsor's protocol ID
- 4-2011-0687
- Status last verified
- Apr 2013
- First submitted
- 10 Apr 2013
- Last updated
- 19 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24722322
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respirophasic Carotid Artery Peak Velocity Variation as a Predictor of Fluid Responsiveness in Patients With Coronary Disease
- ClinicalTrials.gov ID
- NCT01836081
- Acronym / sponsor ID
- 4-2011-0687
- Conditions
- Coronary Artery Occlusive Disease
- Keywords
- fluid responsiveness, carotid artery peak velocity variation, coronary disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 19 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fluid responsiveness | Experimental | Other: Volume expansion |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. patients scheduled for elective isolated off-pump coronary artery bypass graft surgery
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volume expansionAlso: volume expansion with 6 mL/kg of 6% hydroxylethyl starch 130/0.4 | Other | fluid responsiveness |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2013.
- Derived from this study: PubMed 24722322Song 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volume expansion in people with Coronary Artery Occlusive Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01836081, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2013.