Clinical trial NCT02714244: Evaluation of the E/e' Ratio of the Mitral Annulus in Predicting Fluid Responsiveness.
Official title: Evaluation of the E/e' Ratio of the Mitral Annulus Measured by Transesophageal Echocardiography in Predicting Fluid Responsiveness.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Left Ventricular Function Diastolic Dysfunction
Fluid Responsiveness
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
First posted: 2016-03-21
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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). 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.


Eligibility criteria: Inclusion Criteria:

* Patients \>18 yrs, undergoing elective coronary artery bypass grafting or surgery will be included.

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Mitral valve E/e' ratio for prediction of fluid responsiveness
timeFrame: 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:
measure: Pulmonary capillary wedge pressure (PCWP) a-wave to v-wave ratio of the for prediction of fluid responsiveness
timeFrame: Waveform measured within the 15 minutes preceding fluid administration and responsiveness evaluation within the 5 minutes following fluid administration and leg raising
measure: Pulse pressure variation (PPV) for prediction of fluid responsiveness
timeFrame: PPV measured within the 15 minutes preceding fluid administration and responsiveness evaluation within the 5 minutes following fluid administration and leg raising
measure: Stroke volume variation (SVV) for prediction of fluid responsiveness
timeFrame: SVV measured within the 15 minutes preceding fluid administration and responsiveness evaluation within the 5 minutes following fluid administration and leg raising
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
References: