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

NCT ID: NCT03222778

Last Updated: 2020-03-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 66 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2020-03-06

Brief Summary

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.

Conditions

Fluid Responsiveness

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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 interventions assigned to this group

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)

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Anesthesiology and Pain Medicine

Seoul, , South Korea

Countries

South Korea

Other Identifiers

4-2017-0403

Identifier Type: -

Identifier Source: org_study_id