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.

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 Overview

• Status: Completed
• Conditions: Left Ventricular Function Diastolic Dysfunction; Fluid Responsiveness
• Intervention / Treatment: Other: Volume expansion

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H1T 1C8
      • Montreal Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	TEE images taken within the 15 minutes before fluid administration and responsiveness evaluation within the 5 minutes following fluid administration and leg raising

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	SVV measured within the 15 minutes preceding fluid administration and responsiveness evaluation within the 5 minutes following fluid administration and leg raising

Collaborators and Investigators

• Sponsor: Montreal Heart Institute

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (ACTUAL): August 1, 2017
• Study Completion (ACTUAL): August 1, 2017

Study Registration Dates

• First Submitted: March 3, 2016
• First Submitted That Met QC Criteria: March 15, 2016
• First Posted (ESTIMATE): March 21, 2016

Study Record Updates

• Last Update Posted (ACTUAL): September 7, 2017
• Last Update Submitted That Met QC Criteria: September 6, 2017
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 2014-1671

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO