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

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ClinicalTrials.gov Identifier: NCT02714244
Recruitment Status : Completed
First Posted : March 21, 2016
Last Update Posted : September 7, 2017
Sponsor:
Information provided by (Responsible Party):
Montreal Heart Institute

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.


Condition or disease Intervention/treatment Phase
Left Ventricular Function Diastolic Dysfunction Fluid Responsiveness Other: Volume expansion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of the E/e' Ratio of the Mitral Annulus Measured by Transesophageal Echocardiography in Predicting Fluid Responsiveness.
Study Start Date : January 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Intervention Details:
  • Other: Volume expansion
    Volume expansion with rapid administration of 500 ml of crystalloid
    Other Name: Lactate Ringer


Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714244


Locations
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Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Sponsors and Collaborators
Montreal Heart Institute
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Responsible Party: Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT02714244    
Other Study ID Numbers: 2014-1671
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: September 7, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No