Stroke Volume VariationNCT01404455
Effect of Wide Pulse Pressure on the Predictability of Stroke Volume Variation for Fluid Responsiveness in Patients Undergoing Off-pump Coronary Artery Bypass Graft
A study testing HES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 500mL loading in people with Stroke Volume Variation, run by Severance Hospital at 1 site in South Korea.
Trial summary
The investigators examined the predictability of stroke volume variation for fluid responsiveness in patients with wide pulse pressure undergoing off-pump coronary artery bypass graft Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stroke Volume Variation
- What is being tested?
- HES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 500mL loading
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2010to Aug 2011
- 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. Age ≥ 20
- 2. elective off-pump coronary artery bypass graft
Who cannot join
- 1. arrhythmia
- 2.EF <40%
- 3.valvular heart dz
- 4.pul HTN
- 5.PAOD
- 6.lung dz
- 7.NYHA IV
- 8.ESRD
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, 120-752
About this study
The investigators examined the predictability of stroke volume variation for fluid responsiveness in patients with wide pulse pressure undergoing off-pump coronary artery bypass graft
- Conditions
- Stroke Volume Variation
- Being tested
- HES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 500mL loading
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 500mL loadingOther
HES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 500mL loading during 15 minutes after induction of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Normal pulse pressure | Other | pulse pressure <60mmHg Receives: Other: HES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 500mL loading |
| Wide pulse pressure | Other | pulse pressure ≥60mmHg Receives: Other: HES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 500mL loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
The predictability of stroke volume variation for fluid responsiveness in patients with wide pulse pressure
Measured: 30 min
Secondary outcomes (1)
Cut off value of stroke volume variation for predicting fluid responsiveness in patients with wide pulse pressure
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2011 (estimated)
- Study startDec 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke Volume VariationStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, So Yeon Kim, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404455
- Sponsor's protocol ID
- IRB 1-2010-0039
- Status last verified
- Jan 2012
- First submitted
- 1 Apr 2011
- Last updated
- 18 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Wide Pulse Pressure on the Predictability of Stroke Volume Variation for Fluid Responsiveness in Patients Undergoing Off-pump Coronary Artery Bypass Graft
- ClinicalTrials.gov ID
- NCT01404455
- Acronym / sponsor ID
- IRB 1-2010-0039
- Conditions
- Stroke Volume Variation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Severance HospitalUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 28 Jul 2011 (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 investigators examined the predictability of stroke volume variation for fluid responsiveness in patients with wide pulse pressure undergoing off-pump coronary artery bypass graft
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal pulse pressure | Other | Other: HES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 500mL loadingpulse pressure <60mmHg |
| Wide pulse pressure | Other | Other: HES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 500mL loadingpulse pressure ≥60mmHg |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Age ≥ 20
- 2. elective off-pump coronary artery bypass graft
Key exclusion criteria (8 listed)
- 1. arrhythmia
- 2.EF <40%
- 3.valvular heart dz
- 4.pul HTN
- 5.PAOD
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 |
|---|---|---|
| HES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 500mL loadingHES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 500mL loading during 15 minutes after induction of anesthesia | Other | Normal pulse pressure, Wide pulse pressure |
Primary outcome
The predictability of stroke volume variation for fluid responsiveness in patients with wide pulse pressure
Time frame: 30 min
1 secondary outcome
Cut off value of stroke volume variation for predicting fluid responsiveness in patients with wide pulse pressure
Time frame: 30 min
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 18 Jan 2012.
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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 HES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 500mL loading in people with Stroke Volume Variation, run by Severance Hospital 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 2 inclusion and 8 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 18 Jan 2012. 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?
The predictability of stroke volume variation for fluid responsiveness in patients with wide pulse pressure (time frame: 30 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2012.