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Evaluation of the E/e' Ratio of the Mitral Annulus in Predicting Fluid Responsiveness.

Evaluation of the E/e' Ratio of the Mitral Annulus Measured by Transesophageal Echocardiography in Predicting Fluid Responsiveness.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02714244
Enrollment
70
Registered
2016-03-21
Start date
2016-01-31
Completion date
2017-08-31
Last updated
2017-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Left Ventricular Function Diastolic Dysfunction, Fluid Responsiveness

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.

Interventions

Volume expansion with rapid administration of 500 ml of crystalloid

Sponsors

Montreal Heart Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mitral valve E/e' ratio for prediction of fluid responsivenessTEE images taken within the 15 minutes before fluid administration and responsiveness evaluation within the 5 minutes following fluid administration and leg raisingTEE 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

Secondary

MeasureTime frameDescription
Pulmonary capillary wedge pressure (PCWP) a-wave to v-wave ratio of the for prediction of fluid responsivenessWaveform measured within the 15 minutes preceding fluid administration and responsiveness evaluation within the 5 minutes following fluid administration and leg raisinga-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
Pulse pressure variation (PPV) for prediction of fluid responsivenessPPV measured within the 15 minutes preceding fluid administration and responsiveness evaluation within the 5 minutes following fluid administration and leg raisingPulse 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
Stroke volume variation (SVV) for prediction of fluid responsivenessSVV measured within the 15 minutes preceding fluid administration and responsiveness evaluation within the 5 minutes following fluid administration and leg raisingStroke 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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026