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

Fluid Responsiveness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02714244
• Other study ID #: 2014-1671
• Status: Completed
• Phase: N/A
• First received: March 3, 2016
• Last updated: September 6, 2017
• Start date: January 2016
• Est. completion date: August 2017

Study information

• Verified date: December 2016
• Source: Montreal Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fluid Responsiveness
• Left Ventricular Function Diastolic Dysfunction

Intervention

Other:
• Volume expansion
Volume expansion with rapid administration of 500 ml of crystalloid

Locations

Country	Name	City	State
Canada	Montreal Heart Institute	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Montreal Heart Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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