Valvular Heart SurgeryNCT02224378
Prediction of Fluid Responsiveness in Atrial Fibrillation Patients Who Underwent Valvular Heart Surgery: Peep-induced Increase in Central Venous Pressure vs. Passive Leg Raising
A study testing peep induced CVP and passive leg raising(PLR) in people with Valvular Heart Surgery, run by Yonsei University at 1 site in South Korea.
Trial summary
Dynamic indices of preload depending on the heart-lung interaction require sinus rhythm and cannot be applied to patients with atrial fibrillation. PEEP-induced increase in central venous pressure (CVP) was shown to be a valid predictor of fluid responsiveness after cardiac surgery in patients with sinus rhythm, and… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Valvular Heart Surgery
- What is being tested?
- peep induced CVP and passive leg raising(PLR)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2012to Oct 2014
- 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
- age ≥20
- atrial fibrillation patients who underwent elective valvular heart surgery
Who cannot join
- age < 20
- LV ejection fraction < 40%
- any pulmonary disease
- end stage renal disease
- high intrabdominal pressure patient
- contraindication of passive leg raising
- deep vein thrombosis
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology & Pain Medicine, Yonsei university college of medicine
Seoul, Seoul, 120-752
About this study
Dynamic indices of preload depending on the heart-lung interaction require sinus rhythm and cannot be applied to patients with atrial fibrillation. PEEP-induced increase in central venous pressure (CVP) was shown to be a valid predictor of fluid responsiveness after cardiac surgery in patients with sinus rhythm, and was speculated to be of value in patients with rhythm other than sinus. The aim of this study is to assess the predictability of PEEP-induced increase in CVP and passive leg raising (PLR)-induced changes in stroke volume index (SVI) on fluid responsiveness in patients with atrial fibrillation following valvular heart surgery.
- Conditions
- Valvular Heart Surgery
- Being tested
- peep induced CVP, passive leg raising(PLR)
- Keywords
- fluid responsiveness, atrial fibrillation, passive leg raising, central venous pressure, valvular heart surgery
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peep induced CVPProcedure or surgery
passive leg raising(PLR)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| peep induced CVP | Experimental | Not described Receives: Procedure: peep induced CVP |
| passive leg raising(PLR) | Active comparator | Not described Receives: Procedure: passive leg raising(PLR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
fluid responsiveness
- ventilator peep setting was adjusted to 0cmH2O as baseline
- Then peep was increased to 10cmH2O for 5 min.
- We set peep to baseline 0cmH2O again, making patients to semirecumbent position following passive leg raising at 30 degree for 5 min.
- After that, 300 ml of hydroxyethyl starch 130/0.4 was infused in the supine position for 10-20 min and haemodynamic variables including SVI were assessed 5 min after completion of fluid challenge.
Measured: 1hr after arriving at ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2014 (estimated)
- Study startMar 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valvular Heart SurgeryStudies 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
- 44 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
- NCT02224378
- Sponsor's protocol ID
- 4-2011-0686
- Status last verified
- Mar 2015
- First submitted
- 19 Aug 2014
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Fluid Responsiveness in Atrial Fibrillation Patients Who Underwent Valvular Heart Surgery: Peep-induced Increase in Central Venous Pressure vs. Passive Leg Raising
- ClinicalTrials.gov ID
- NCT02224378
- Acronym / sponsor ID
- 4-2011-0686
- Conditions
- Valvular Heart Surgery
- Keywords
- fluid responsiveness, atrial fibrillation, passive leg raising, central venous pressure, valvular heart surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 25 Aug 2014 (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.
Dynamic indices of preload depending on the heart-lung interaction require sinus rhythm and cannot be applied to patients with atrial fibrillation. PEEP-induced increase in central venous pressure (CVP) was shown to be a valid predictor of fluid responsiveness after cardiac surgery in patients with sinus rhythm, and was speculated to be of value in patients with rhythm other than sinus. The aim of this study is to assess the predictability of PEEP-induced increase in CVP and passive leg raising (PLR)-induced changes in stroke volume index (SVI) on fluid responsiveness in patients with atrial fibrillation following valvular heart surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| peep induced CVP | Experimental | Procedure: peep induced CVP |
| passive leg raising(PLR) | Active comparator | Procedure: passive leg raising(PLR) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age ≥20
- atrial fibrillation patients who underwent elective valvular heart surgery
Key exclusion criteria (7 listed)
- age < 20
- LV ejection fraction < 40%
- any pulmonary disease
- end stage renal disease
- high intrabdominal pressure patient
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 |
|---|---|---|
| peep induced CVP | Procedure or surgery | peep induced CVP |
| passive leg raising(PLR) | Procedure or surgery | passive leg raising(PLR) |
Primary outcome
fluid responsiveness
Time frame: 1hr after arriving at ICU
1. ventilator peep setting was adjusted to 0cmH2O as baseline 2. Then peep was increased to 10cmH2O for 5 min. 3. We set peep to baseline 0cmH2O again, making patients to semirecumbent position following passive leg raising at 30 degree for 5 min. 4. After that, 300 ml of hydroxyethyl starch 130/0.4 was infused in the supine position for 10-20 min and haemodynamic variables including SVI were assessed 5 min after completion of fluid challenge.
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 1 Apr 2015.
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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 peep induced CVP and passive leg raising(PLR) in people with Valvular Heart Surgery, 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 2 inclusion and 7 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 1 Apr 2015. 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?
fluid responsiveness (time frame: 1hr after arriving at ICU). 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 1 Apr 2015.