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

NCT ID: NCT02714244

Last Updated: 2017-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-08-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Interventions

Volume expansion

Volume expansion with rapid administration of 500 ml of crystalloid

Intervention Type: OTHER

Other Intervention Names

Lactate Ringer

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Montreal Heart Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Montreal Heart Institute

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 37386580 (View on PubMed)

Other Identifiers

2014-1671

Identifier Type: -

Identifier Source: org_study_id