Combination of Static Echocardiographic Indices for Prediction of Fluid Responsiveness During Cardiac Surgery

In the perioperative or critical care of hemodynamically unstable patients, appropriate fluid resuscitation guided by reliable preload indices is of pivotal importance as only half of them are fluid responsive, and that empiric fluid administration actually leads to dismal prognosis. In the continuum of being non-invasive, combinations of tissue Doppler-derived parameters of early (e') and late (a') diastolic, and peak systolic velocity (s') of the mitral annulus provide information regarding the systolic dysfunction and preload (e'/s'), and LV stiffness (e'/a'). Although the left ventricular end-diastolic area (LVEDA) alone is not a valid predictor of fluid responsiveness, combining LVEDA with these indices would provide comprehensive information regarding the LV dimension, preload, and compliance as well as systolic function. Also, it seems logical to assume that patients with low LVEDA and high e' velocity indicating preserved early diastolic relaxation or low e (early mitral inflow velocity) /e' ratio indicating normal LV filling pressure would more likely be fluid responsive. Yet, these assumptions have not been tested before. Moreover, these values can be reliably obtained regardless of the heart rhythm, except for a', and do not completely rely on heart-lung interaction as opposed to the dynamic indices. Thus, the aim of this prospective trial is to investigate the role of LVEDA combined with e, e', a' or s' as a preload index in predicting fluid responsiveness in patients scheduled for off-pump coronary bypass surgery, in closed-chest conditions.

Study Overview

• Status: Completed
• Conditions: Fluid Responsiveness

• Study Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Department of anesthesiology and pain medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients scheduled for off-pump coronary bypass surgery

Description

Inclusion Criteria:

1. the patients scheduled for off-pump coronary bypass surgery
2. tha age ≥20 yrs old
3. the patients who are willing to provide written informed consent

Exclusion Criteria:

heart rhythm other than sinus, L, septal and/or lateral wall motion abnormalities, and a

1. New York Heart Association functional class ≥III
2. LV ejection fraction <40%
3. emergency operation
4. the patients with preoperative septal and/or lateral wall motion abnormalities
5. contraindications to transesophageal echocardiography or balanced 6% hydroxyethyl starch 130/0.4
6. the patients with any valvular heart disease ≥moderate degree
7. No communication possible due to a language barrier or deafness

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
hypovolemia (fluid responsiveness); The patients with fluid responsiveness (an increase in stroke volume index of ≥12%) after fluid challenge using 6 ml/kg of balanced 6% hydroxyethyl starch 130/0.4 (Volulyte; Fresenius Kabi, Bad Homburg, Germany)
NO hypovolemia (NO fluid responsiveness); The patients without fluid responsiveness after fluid challenge using 6 ml/kg of balanced 6% hydroxyethyl starch 130/0.4 (Volulyte; Fresenius Kabi, Bad Homburg, Germany)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive ability of combined echocardiographic index consisting of LVEDA, e, e', s' or a'	Fluid challenge is performed once using 6 ml/kg of balanced 6% hydroxyethyl starch 130/0.4 (Volulyte; Fresenius Kabi, Bad Homburg, Germany) 15 to 20 min after anesthetic induction during closed chest condition. Fluid responsiveness is defined as an increase in stroke volume index of ≥ 15%. Assessment of echocardiographic variables [LVEDA, e, e', a' or s'] is performed before fluid challenge. We assess the predictive ability of a combined echocardiographic preload index consisting of LVEDA, e, e', s' or a' on fluid responsiveness using the area under the Receiver Operating Characteristic (ROC) curve (AUROC).	15 to 20 min after anesthetic induction during closed chest condition

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison between the combine echocardiographic index and LVEDA alone, CVP, PCWP, RVEDV and PPV for the predictive ability on fluid responsiveness	CVP, PCWP, RVEDV and PPV are measured as well as echocardiographic variables [LVEDA, e, e', a' or s'] before fluid challenge. We also assess the predictive ability of LVEDA alone, CVP, PCWP, RVEDV and PPV on fluid responsiveness using each AUROC, and compare the predictive power of the combined echocardiographic index on fluid responsiveness with those of the LVEDA alone, CVP, PCWP, RVEDV, and PPV.	15 to 20 min after anesthetic induction during closed chest condition

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): March 6, 2020
• Study Completion (Actual): March 6, 2020

Study Registration Dates

• First Submitted: July 9, 2017
• First Submitted That Met QC Criteria: July 17, 2017
• First Posted (Actual): July 19, 2017

Study Record Updates

• Last Update Posted (Actual): March 27, 2020
• Last Update Submitted That Met QC Criteria: March 26, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: fluid responsiveness; tissue doppler; off-pump coronary bypass surgery
• Other Study ID Numbers: 4-2017-0403

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No