Left Ventricular Function Diastolic DysfunctionNCT02714244
Evaluation of the E/e' Ratio of the Mitral Annulus in Predicting Fluid Responsiveness.
A study testing Volume expansion in people with Left Ventricular Function Diastolic Dysfunction and Fluid Responsiveness, run by Montreal Heart Institute at 1 site in Canada.
Trial summary
Diastolic function may be evaluated by different measurements on transesophageal echocardiography (TEE). They include mitral inflow velocities obtained by pulsed-wave doppler (PW) : peak early diastolic velocity (E) and late diastolic velocity (A). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Ventricular Function Diastolic Dysfunction, Fluid Responsiveness
- What is being tested?
- Volume expansion
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2016to Aug 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients >18 yrs, undergoing elective coronary artery bypass grafting or surgery will be included.
Who cannot join
- Significant mitral valvular heart disease (mitral regurgitation ≥ 2/4 or stenosis)
- Significant right sided valvular heart disease (tricuspid regurgitation ≥ 2/4)
- Intracardiac shunts
- Emergency surgery
- Non-sinusal rythme
- Clinical evidence of decompensated heart failure
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- Clinical evidence of decompensated pulmonary hypertension
- Renal insufficiency with creatinine clairance ≤ 30 cc/min or dialysis
- Contraindications to TEE, including esophageal disease or unstable cervical spine
- CVP ≥ 15 mm Hg or PCWP ≥ 18 mm Hg immediately before fluid infusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the E/e' Ratio of the Mitral Annulus Measured by Transesophageal Echocardiography in Predicting Fluid Responsiveness.
Diastolic function may be evaluated by different measurements on transesophageal echocardiography (TEE). They include mitral inflow velocities obtained by pulsed-wave doppler (PW) : peak early diastolic velocity (E) and late diastolic velocity (A). Mitral annulus velocities, early diastolic (e') and late diastolic (a') are obtained by tissue doppler imaging (TDI). The ratio E/e' reflects left ventricular filling pressure and, as such, might be a predictor of fluid responsiveness.
The aim of this study is to evaluate the predictive value of the mitral valve E/e' ratio for fluid responsiveness among patients undergoing coronary bypass graft surgery. Fluid responsiveness being defined as an increase in stroke volume of ≥ 15%.
After induction of anesthesia, patients will have their diastolic function evaluated by means of E/e' and other measures. They will then be administered an intravenous bolus of 500 mL of Lactate Ringer® along with passive leg raising (PLR). Stroke volume and fluid responsiveness will be assessed by the thermodilution method (Swan-Ganz catheter) and the FloTrac® device. Fluid responders will be compared to non-responders to evaluate the relationship between E/e' ratio and fluid responsiveness.
- Being tested
- Volume expansion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volume expansionOther
Also called Lactate Ringer
Volume expansion with rapid administration of 500 ml of crystalloid
What is being measured
The primary outcome is the main question the study is designed to answer.
Mitral valve E/e' ratio for prediction of fluid responsiveness
TEE evaluation of mitral inflow velocities and mitral annulus velocities measured right before fluid administration as a predictor of fluid responsiveness defined as an increase of 15% or more of the stroke volume
Measured: TEE images taken within the 15 minutes before fluid administration and responsiveness evaluation within the 5 minutes following fluid administration and leg raising
Secondary outcomes (3)
Pulmonary capillary wedge pressure (PCWP) a-wave to v-wave ratio of the for prediction of fluid responsiveness
a-wave on v-wave ratio of the pulmonary capillary wedge pressure (PCWP) curve for prediction of fluid responsiveness defined as an increase of 15% or more of the stroke volume
Measured: Waveform measured within the 15 minutes preceding fluid administration and responsiveness evaluation within the 5 minutes following fluid administration and leg raising
Pulse pressure variation (PPV) for prediction of fluid responsiveness
Pulse pressure variation (PPV) measured on arterial pressure curve for prediction of fluid responsiveness defined as an increase of 15% or more of the stroke volume
Measured: PPV measured within the 15 minutes preceding fluid administration and responsiveness evaluation within the 5 minutes following fluid administration and leg raising
Stroke volume variation (SVV) for prediction of fluid responsiveness
Stroke volume variation (SVV) directly measured by FloTrac/Vigileo® with its intrinsic algorithm for prediction of fluid responsiveness defined as an increase of 15% or more of the stroke volume
Measured: SVV measured within the 15 minutes preceding fluid administration and responsiveness evaluation within the 5 minutes following fluid administration and leg raising
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionAug 2017
- Study completionAug 2017
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 Left Ventricular Function Diastolic DysfunctionStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714244
- Sponsor's protocol ID
- 2014-1671
- Status last verified
- Dec 2016
- First submitted
- 3 Mar 2016
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Courbe A, Perrault-Hebert C, Ion I, Desjardins G, Fortier A, Denault A, Deschamps A, Couture P. Should we use diastolic function parameters to determine preload responsiveness in cardiac surgery? A pilot study. J Anesth Analg Crit Care. 2021 Oct 30;1(1):12. doi: 10.1186/s44158-021-00014-7.
PubMed 37386580
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the E/e' Ratio of the Mitral Annulus Measured by Transesophageal Echocardiography in Predicting Fluid Responsiveness.
- ClinicalTrials.gov ID
- NCT02714244
- Acronym / sponsor ID
- 2014-1671
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 21 Mar 2016 (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.
Diastolic function may be evaluated by different measurements on transesophageal echocardiography (TEE). They include mitral inflow velocities obtained by pulsed-wave doppler (PW) : peak early diastolic velocity (E) and late diastolic velocity (A). Mitral annulus velocities, early diastolic (e') and late diastolic (a') are obtained by tissue doppler imaging (TDI). The ratio E/e' reflects left ventricular filling pressure and, as such, might be a predictor of fluid responsiveness.
The aim of this study is to evaluate the predictive value of the mitral valve E/e' ratio for fluid responsiveness among patients undergoing coronary bypass graft surgery. Fluid responsiveness being defined as an increase in stroke volume of ≥ 15%.
After induction of anesthesia, patients will have their diastolic function evaluated by means of E/e' and other measures. They will then be administered an intravenous bolus of 500 mL of Lactate Ringer® along with passive leg raising (PLR). Stroke volume and fluid responsiveness will be assessed by the thermodilution method (Swan-Ganz catheter) and the FloTrac® device. Fluid responders will be compared to non-responders to evaluate the relationship between E/e' ratio and fluid responsiveness.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients >18 yrs, undergoing elective coronary artery bypass grafting or surgery will be included.
Key exclusion criteria (10 listed)
- Significant mitral valvular heart disease (mitral regurgitation ≥ 2/4 or stenosis)
- Significant right sided valvular heart disease (tricuspid regurgitation ≥ 2/4)
- Intracardiac shunts
- Emergency surgery
- Non-sinusal rythme
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: Lactate RingerVolume expansion with rapid administration of 500 ml of crystalloid | Other | – |
Primary outcome
Mitral valve E/e' ratio for prediction of fluid responsiveness
Time frame: TEE images taken within the 15 minutes before fluid administration and responsiveness evaluation within the 5 minutes following fluid administration and leg raising
TEE evaluation of mitral inflow velocities and mitral annulus velocities measured right before fluid administration as a predictor of fluid responsiveness defined as an increase of 15% or more of the stroke volume
3 secondary outcomes
Pulmonary capillary wedge pressure (PCWP) a-wave to v-wave ratio of the for prediction of fluid responsiveness
Time frame: Waveform measured within the 15 minutes preceding fluid administration and responsiveness evaluation within the 5 minutes following fluid administration and leg raising
Pulse pressure variation (PPV) for prediction of fluid responsiveness
Time frame: PPV measured within the 15 minutes preceding fluid administration and responsiveness evaluation within the 5 minutes following fluid administration and leg raising
Stroke volume variation (SVV) for prediction of fluid responsiveness
Time frame: SVV measured within the 15 minutes preceding fluid administration and responsiveness evaluation within the 5 minutes following fluid administration and leg raising
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 7 Sep 2017.
- Derived from this study: PubMed 37386580Courbe A, Perrault-Hebert C, Ion I, Desjardins G, Fortier A, Denault A, Deschamps A, Couture P. Should we use diastolic function parameters to determine preload responsiveness in cardiac surgery? A pilot study. J Anesth Analg Crit Care. 2021 Oct 30;1(1):12. doi: 10.1186/s44158-021-00014-7.
- Individual participant dataSharing planned: No
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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 Left Ventricular Function Diastolic Dysfunction and Fluid Responsiveness, run by Montreal Heart Institute at 1 site in Canada.
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 10 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 7 Sep 2017. 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 Canada. 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?
Mitral valve E/e' ratio for prediction of fluid responsiveness (time frame: TEE images taken within the 15 minutes before fluid administration and responsiveness evaluation within the 5 minutes following fluid administration and leg raising). 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 NCT02714244, 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 7 Sep 2017.