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

NCT02714244 | Completed

• 1 other identifier: 2014-1671
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Left Ventricular Function Diastolic Dysfunction; Fluid Responsiveness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pulmonary capillary wedge pressure (PCWP) a-wave to v-wave ratio of the for prediction of fluid responsiveness

  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

  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

  SVV measured within the 15 minutes preceding fluid administration and responsiveness evaluation within the 5 minutes following fluid administration and leg raising

Interventions

Volume expansion OTHER

Volume expansion with rapid administration of 500 ml of crystalloid

Also known as: Lactate Ringer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \>18 yrs, undergoing elective coronary artery bypass grafting or surgery will be included.

You may not qualify if:

• 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

Sponsors & Collaborators

• Montreal Heart Institute: lead

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Related Publications (1)

• Courbe A, Perrault-Hebert C, Ion I, Desjardins G, Fortier A, Denault A, Deschamps A, Couture P. Should we use diastolic function parameters to determine preload responsiveness in cardiac surgery? A pilot study. J Anesth Analg Crit Care. 2021 Oct 30;1(1):12. doi: 10.1186/s44158-021-00014-7.

  PMID: 37386580 DERIVED

MeSH Terms

Interventions

Ringer's Lactate

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: March 21, 2016
• Study Start: January 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: September 7, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)