Fluid Responsiveness PredictabilityNCT01819571
Pulse Pressure Variation for Prediction of Fluid Responsiveness in Coronary Artery Disease Patients With Diastolic Dysfunction
A study testing Fluid loading (Voluven) in people with Fluid Responsiveness Predictability, run by Yonsei University at 1 site in South Korea.
Trial summary
The investigators hypothesized that predictability of pulse pressure variation (PPV) on fluid responsiveness would be reduced in patients with coronary disease who have diastolic dysfunction. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Fluid Responsiveness Predictability
- What is being tested?
- Fluid loading (Voluven)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2012to Oct 2013
- 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
- Patients older than 20 years
- scheduled for elective coronary artery bypass grafting
- normal diastolic function (E/E' < 8) or diastolic dysfunction (E/E' >15) according to preoperative Echocardiographic evaluation
Who cannot join
- arrythmia,
- reduced left ventricular function (ejection fraction < 40%)
- valvular heart disease requiring concomitant surgical correction
- pulmonary hypertension (mean pulmonary arterial pressure ≥30 mm Hg)
- peripheral arterial occlusive disease, pulmonary disease (asthma, chronic obstructive pulmonary disease, and lung resection)
- end-stage renal disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of anesthesiology and pain medicine
Seoul, Seoul, 120-752
About this study
The investigators hypothesized that predictability of pulse pressure variation (PPV) on fluid responsiveness would be reduced in patients with coronary disease who have diastolic dysfunction.
- Conditions
- Fluid Responsiveness Predictability
- Being tested
- Fluid loading (Voluven)
- Keywords
- pulse pressure variation, fluid responsiveness, diastolic dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid loading (Voluven)Drug
Also called Fluid loading
HES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 8ml / kg loading during 15 minutes after induction of anesthesia on both groups
| Study group | Role | What they receive |
|---|---|---|
| Normal diastolic function group | Experimental | Not described Receives: Drug: Fluid loading (Voluven) |
| Diastolic dysfunction group | Active comparator | Not described Receives: Drug: Fluid loading (Voluven) |
What is being measured
The primary outcome is the main question the study is designed to answer.
predictability of pulse pressure variation (PPV) on fluid responsiveness in patients with coronary disease who have normal diastolic function and diastolic dysfunction.
After induction of anesthesia and applying mechanical ventilation, hemodynamic parameters (including PPV measured by Philips IntelliVue MP 70®) were recorded
Measured: 10 minutes after fluid replacement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startJan 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid Responsiveness PredictabilityStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 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
- NCT01819571
- Sponsor's protocol ID
- 1-2011-0056
- Status last verified
- Feb 2014
- First submitted
- 14 Mar 2013
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulse Pressure Variation for Prediction of Fluid Responsiveness in Coronary Artery Disease Patients With Diastolic Dysfunction
- ClinicalTrials.gov ID
- NCT01819571
- Acronym / sponsor ID
- 1-2011-0056
- Conditions
- Fluid Responsiveness Predictability
- Keywords
- pulse pressure variation, fluid responsiveness, diastolic dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 27 Mar 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 investigators hypothesized that predictability of pulse pressure variation (PPV) on fluid responsiveness would be reduced in patients with coronary disease who have diastolic dysfunction.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal diastolic function group | Experimental | Drug: Fluid loading (Voluven) |
| Diastolic dysfunction group | Active comparator | Drug: Fluid loading (Voluven) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients older than 20 years
- scheduled for elective coronary artery bypass grafting
- normal diastolic function (E/E' < 8) or diastolic dysfunction (E/E' >15) according to preoperative Echocardiographic evaluation
Key exclusion criteria (6 listed)
- arrythmia,
- reduced left ventricular function (ejection fraction < 40%)
- valvular heart disease requiring concomitant surgical correction
- pulmonary hypertension (mean pulmonary arterial pressure ≥30 mm Hg)
- peripheral arterial occlusive disease, pulmonary disease (asthma, chronic obstructive pulmonary disease, and lung resection)
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 |
|---|---|---|
| Fluid loading (Voluven)Also: Fluid loadingHES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 8ml / kg loading during 15 minutes after induction of anesthesia on both groups | Drug | Diastolic dysfunction group, Normal diastolic function group |
Primary outcome
predictability of pulse pressure variation (PPV) on fluid responsiveness in patients with coronary disease who have normal diastolic function and diastolic dysfunction.
Time frame: 10 minutes after fluid replacement
After induction of anesthesia and applying mechanical ventilation, hemodynamic parameters (including PPV measured by Philips IntelliVue MP 70®) were recorded
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 Feb 2014.
Related trials for Fluid Responsiveness Predictability
Recruiting
A Study Comparing Carotid Doppler Ultrasound and Echocardiography to Assess Fluid Responsiveness in Septic Patients on Ventilator
Fluid Responsiveness Predictability in Sepsis
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 Fluid loading (Voluven) in people with Fluid Responsiveness Predictability, 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 3 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 Feb 2014. 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?
predictability of pulse pressure variation (PPV) on fluid responsiveness in patients with coronary disease who have normal diastolic function and diastolic dysfunction. (time frame: 10 minutes after fluid replacement). 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 19 Feb 2014.