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Completed

NCT Number: NCT02714244

Evaluation of the E/e' Ratio of the Mitral Annulus 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.

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Key information

Conditions

Left Ventricular Function Diastolic Dysfunction Fluid Responsiveness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

volume expansion

Other

Volume expansion with rapid administration of 500 ml of crystalloid

Other names: Lactate Ringer

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    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

  2. 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

    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

  3. 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

    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

Sponsors and collaborators

Lead sponsor

Montreal Heart Institute

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 21, 2016
Registry last updated
Sep 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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